Title: CSVP – InstantGMP™ User Manual-3.000.001 Document No: CSVP-UM-IGMP- 3.000.001 Effective upon last signature date Page: 1 of 122 1 Approvals Name Title Organization Signature Date System Owner: Richard Soltero President InstantGMP 6/2/16 Software QA: Gretchen Rizor QA InstantGMP 6/1/2016 Version History Version Date (MM/DD/YY YY) Description of Change 00 02072014 New Document 01/ 2.045 070214 Made changes for the new Unit table/page/workflow. 02/ 2.045.008 09/10/14 Updated the new specification workflow. 03/2.045.009 11/17/14 Updated with new batch material use workflow 04/2.050.001 05/18/2015 The default Role can be assigned from the personnel screen. Personnel may login immediately after role assignment on this screen. (p 21) Added Optional Features section (p20) Added note about ability to sort by batch issuance stamp (p89) Deleted signatures for Material vendor qualification and updated screen shot. (p 39) Updated new specification workflow (pp 40-45) Updated reports to reflect being sourced from within GeneXus. (pp 99-102) 05 / 2.051.002 07/22/2015 Added a section for the new barcode scan features for user badges and material labels. Added Sign with badge add tests and browse buttons to icon glossary. Edited Order to sort with new icon in glossary. 06/ 2.052.001 12/2/2015 Deleted CPC, addressed client change, deleted : Selecting “Y” from the “Qualified Vendor” dropdown will return all materials that have qualified vendors. “N” will return all materials whose vendor has not been qualified. “Clear” will return all materials.” 2.053.002 12/13/2016 project changes, Product name, Primary container, copy function, version up function, scale up function,
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Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
Page: 1 of 122
1
Approvals
Name Title Organization Signature Date
System Owner:
Richard Soltero
President InstantGMP
6/2/16
Software QA:
Gretchen Rizor
QA InstantGMP
6/1/2016
Version History
Version Date
(MM/DD/YY
YY)
Description of Change
00 02072014 New Document
01/ 2.045 070214 Made changes for the new Unit table/page/workflow.
02/
2.045.008 09/10/14 Updated the new specification workflow.
03/2.045.009 11/17/14 Updated with new batch material use workflow
04/2.050.001 05/18/2015
The default Role can be assigned from the personnel screen.
Personnel may login immediately after role assignment on this
screen. (p 21) Added Optional Features section (p20) Added
note about ability to sort by batch issuance stamp (p89)
Deleted signatures for Material vendor qualification and
updated screen shot. (p 39)
Updated new specification workflow (pp 40-45) Updated
reports to reflect being sourced from within GeneXus. (pp
99-102)
05 /
2.051.002 07/22/2015
Added a section for the new barcode scan features for user
badges and material labels. Added Sign with badge add tests
and browse buttons to icon glossary. Edited Order to sort with
2.054.002 05/09/2016 Min max patch – new error messages
3.000.001 05/09/2016 See release notes below
Table of Contents
Table of Contents ............................................................................................................................ 2 Release Notes: ................................................................................................................................. 3 User Manual Summary ................................................................................................................. 11 Overview of Main Menu and Sub-menu choices ......................................................................... 11
Manufacturing Process Overview ................................................................................................. 24 Starting a New Project .................................................................................................................. 24
Vendors ..................................................................................................................................... 28 Material Types .......................................................................................................................... 30 Material Status .......................................................................................................................... 32
Storage Condition ..................................................................................................................... 34 Unit ........................................................................................................................................... 34
Methods..................................................................................................................................... 40 Countries ................................................................................................................................... 41
Material ......................................................................................................................................... 43
Material Specifications ................................................................................................................. 46 Creating a Project .......................................................................................................................... 51
Inventory ....................................................................................................................................... 62 This module includes Receipt, Status update and Use of a material. ........................................... 62
Material Receipt ........................................................................................................................ 62
Master Batch Records ................................................................................................................... 77
Master Record Cover Page ....................................................................................................... 80 Master Record: Bill of Materials .............................................................................................. 81
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Master Record Equipment ........................................................................................................ 84 Master Records In-Process Tests .............................................................................................. 85 Master Production Record Manufacturing Instructions ............................................................ 86 Master Record: MPR Approvals ............................................................................................... 92
Batch Production Record .............................................................................................................. 94 Batch Production Cover Page ................................................................................................... 95 Batch Record Manufacturing Instructions .............................................................................. 100 Batch Record Approval........................................................................................................... 107
InstantGMP runs on PCs and Macs as well as Windows based tablets (Full version of windows
not RT) and iOS.
Overview of Main Menu and Sub-menu choices
There are eight (8) Main Menu choices that reside at the left of the opening screen. Each of them
have additional sub-menus choices.
The following main menu choices are found to the left of the main application screen. They
contain sub-menu choices which are selected to enter in data. 1. Setup 2. Materials 3. Specifications 4. Requisitions 5. Inventory 6. Logs 7. Project 8. Batch Record 9. Audit 10. Reports
Sub-menus (signified by bold grey text e.g. Set-Up Personnel:) The main menu choices have
sub-menus from which to choose in order to complete various activities. For example, Set-Up
consists of sub-menus that open data tables. The Personnel table contains the names and contact
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information of personnel. The Vendor table contains the names and contact information of
various material vendors.
1. Set Up
a) Personnel
b) Vendor
c) Material Type (raw materials, components, WIP, Finished Goods, etc.)
d) Material Status (Approved, Quarantine, Rejected)
e) Storage Condition
f) Unit
g) Facility
h) Room
i) Bin
j) Equipment
k) Tests
l) Methods
m) Countries
2. Material (including Finished Goods, WIP, and Raw Materials)
3. Specifications
a) Add Material Specifications
b) View Material Specifications
4. Requisitions
5. Inventory
a) Material Receipt
b) Inventory Status (quarantined, approved, etc.)
c) Inventory Management
d) Depleted Inventory
6. Project
a) Project Definition (Project & Product information)
b) WIP/FG material list
c) Project (Client Information)
c) Project Personnel
7. Logs (use, cleaning, maintenance)
a) Room Log
b) Equipment Log
8. Batch Record
a) MPR Record Definition
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b) Batch Production Record
9. Audit
a) Audit Log
b) Audit Attribute
10. Reports
a) Current inventory
b) Inventaory
c) Inventory in Quarantine
d) Equipment CAL/PM Date
e) Production Lot Traceability
f) Vendor Lot Traceability
g) Low Inventory Levels
There is a set workflow inherent to the program so that the GMP checks and balances can be
carried out in real time; thus there is an order in which the training and test scripts must be executed
for success. The order generally follows the menu items from top to bottom.
Your trainer has access to the DBADM (database administrator) dashboard whereby they can
toggle on and off certain features.
Specifications may be turned off (Note: this feature is not meant to be turned on and off repeatedly)
inventory checks for Material amounts can be turned off
Allowance for same user to sign for log and batch record operator and verifier for those not ready
for full adherence to GMPs.
Abbreviations
Abbreviation Description
ADM Administrator (ambiguous role that has access to
personnel screens to get started with the
program)
BOM Bill of Materials
BPR Batch Production Record
CoA Certificate of Analysis
FG Finished Good
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Abbreviation Description
ADM Administrator (ambiguous role that has access to
personnel screens to get started with the
program)
BOM Bill of Materials
ID Identification
IT Information Technology
MPR Master Production Record
MSDS Material Safety Data Sheets
oWIP Outgoing Work In Process
PM Project Manager
PS Production Supervisor
QM Quality Manager
Req Requisition, Purchase Order (with no associated
cost )
WIP Work in Process
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Definition Glossary
Acceptance Limit: result requirement for passing test.
Administrator/ADM: the personnel who have full permissions (except no access to security) set
for MES modules of InstantGMP functions. An Administrator can always view and edit,
however, they are generally not part of manufacturing projects or teams. An Administrator must
be assigned to the system in order to add other personnel and set security.
Approval: Formal permission or sanction needed: signature.
Approved: Confirmed or sanctioned formally, by signature. For materials and products: passed
all specifications and is fit for use, distribution or sale.
Bin Location: location of materials as uniquely defined by further organization than room
#/name.
Batch size: Amount of a finished batch, to be associated with corresponding unit.
BPR: Batch Production Record; the unique and numbered documentation of the manufacture of
a specific production run or batch of product. The BPR will have a unique batch (production or
lot) number and the capture of weights, times, and other results will be specific to one instance of
following the included instructions.
Client: the person or company who is responsible for funding the project.
Close: close the web page without saving changes.
Company: Your firm, plant, or company name (as editable on the DBADM dashboard only; this
is displayed in the upper right hand corner of the application)
Conditional Approval: Confirmed or sanctioned formally, by signature, but with restrictions;
permission to use at risk but not to ship, or pending some specified action.
Confirm: close the web page with changes saved.
DBADM: Data Base Administrator; role in InstantGMP utilized by InstantGMP support
specialist to provide customer service and for QA tester to perform U/FAT/OP/OQ testing.
Formulation ID: number or name identifying the specific recipe, formula, instructions, product
strength, flavor, unit, etc. of a product; Client Product Code can be used as a base.
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Production Supervisor: the personnel role subordinate to Project Manager who is responsible
for overseeing InstantGMP production at the manufacturing site.
Product Code (lite): internal code for product.
In-Process Test: Testing or inspection of any ingredients or components of a product or WIP
during any production phase.
Instance: Customer-specific, secure, cloud-based Database of InstantGMP.
Instance Owner: the company who has been assigned a specific instance of the InstantGMP
data base and who has control of the personnel, materials, facilities, equipment, projects, logs,
specifications, inventory, batch records and security settings for that specific instance.
Insert: to add new record.
Inventory Manager: Role specifically for those who purchase the Inventory version of IGMP
with modified permissions to exclude Projects, masters and batch records and includes more
rights than an operator. (similar to a PM with QM rights for material handling)
Inventory Operator: Role specifically for those who purchase the Inventory version of IGMP
with modified permissions to exclude Projects, masters and batch records and includes more
rights than an operator.
Material: any component, excipient, reagent, active ingredient or drug product that is needed for
or manufactured by InstantGMP.
Material Type: The Physical form of a material.
MPR: Master Production Record, A written template for the recipe and manufacturing
instruction steps and other info necessary for completing manufacture product.
Operator: the personnel who use InstantGMP to perform warehouse and production activities.
Order: drop down which allows users to order the results of a summary screen by any column
header.
Outgoing work in process: Partially processed material that is either held for further
processing, sold to a middleman or distributor, etc. treated like a finished good in inventory
after processing if added to inv via the button on batch record.
Performer: User/operator who completed task.
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Personnel: Interchangeable with user, person assigned a name and password in the application.
Print: provide a hard copy or PDF copy.
Product Name: product to be produced, and for which to write an MPR.
Defined in the project by the concatenation of the material name, strength, primary container and
suffix.
Project: (MES only) precursor to creating an MPR, assigning a WIP or FG part number with
additional titles and associating with a client (differentiate the client/sponsors’ MPRs from other
projects.)
Project Manager: the personnel who have the InstantGMP responsibilities defined in the Project
Initiation SOP. They are generally in charge of the project team and administration for
manufacturing projects.
Production Supervisor: Operations manager at the floor level responsible for Production
Operators and Operations including log responsibilities.
Quality Manager: the personnel who have the InstantGMP responsibilities defined in the
Quality Management SOP. They are generally responsible for quality oversight and approval of
quality operations in manufacturing projects.
Quality Operator: Role allowing for more permissions than an operator for Quality control
analysts.
Quarantine: Isolate or put on hold; not for use until further notice, the status all received and
batch-created materials default to in InstantGMP.
Rejected: Not accepted, not allowed to be used.
Requisition: request/order for materials from vendors.
Save: to retain.
Screen/page name: Developer chosen screen names visible at bottom left of each screen. This
differs from the title of the screen which appears across the top left of each screen in large blue
lettering.
Specification: Set of parameters defining the tests and limits required for acceptance of a
material for use in production or for distribution or sale.
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Status: Standard state of Quality of a component, excipient, API, raw material, WIP or finished
Product; used to assess a material’s safety and conformance to applicable specifications.
Standards are Quarantine, Approved, and Rejected.
System Type: Status of a material, FG, WIP, Raw.
Test: name of the test or goal of a procedure.
Test Method: Description of how a specific test is performed, standard to follow.
Theoretical yield: Amount of product that could theoretically be produced from a recipe in the
MPR given no loss (via deviations, testing/samples, QA inspection rejects, normal operation loss
e.g. lost in air, residue on equipment, batch does not fill full integer of containers, etc.)
Title: User Functional Screen Title visible in Blue font in top left of screen.
Update: to modify a record; add, edit or delete.
User: The individual with a user ID and password.
Verifier: Personnel to sign for verification of a manufacturing step which a performer has
completed.
Verify: to confirm the truth or correctness of (something).
iWIP: Work in process; incoming goods that will be used as ingredients in manufacturing.
Icon Glossary
User Name and Role: A drop down in the upper right hand corner of the screen that lists the
roles that are currently assigned which user may toggle between.
Note: This feature is for convenience and special circumstances and should be used responsibly
and only within the scope of 21CFR part 11.
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Title: At the top of the page the screen name indicates what kind of data the system will display
in the current screen In the example, the title says "MPR Record Definition"
Direct Access Icons: At the upper-right part of the screen there are, depending on user rights,
three active icons:
o Password (change password)
o Favorite
o Home button (resets to see entire menu)
o Security (change user rights to the current screen) , and
o Logout (leave the application)
Pagination Buttons: The information in the grid is displayed in groups of usually 50 records. To
access the next 50, there are paging buttons:
The "First" button: , the "Previous" button: , the "Next" button: and the “Last"
button to access the chosen number of records.
The Qty of rows field allows users to adjust the amount of rows displayed on the screen. Enter
the number desired and select the icon.
In some cases there may be an “Add New Record” button, to add new records.
The Confirm button registers the entered data into the data base. The Close button closes the
screen and returns the user to the previous screen but does not save any changes in the database.
The Search button searches for the entered data. The Clear button clears all data from the search
function and resets the screen to include all data.
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The print button appears on several pages and allows the user to print an MPR or BPR.
A report for Material Specifications can be printed using the report button.
The “Copy Manufacturing Steps From Another MPR” button allows the user to select from a list
of MPRs from which to import the manufacturing steps.
The “Copy Materials From Another MPR” button allows the user to select from a list of MPRs
from which to import the materials.
The “Copy Equipment From Another MPR” button allows the user to select from a list of MPRs
from which to import the equipment.
The “Copy Tests From Another MPR” button allows the user to select from a list of MPRs from
which to import the tests.
The sign button comes in different forms and prompts the pop-up signature box. Performer,
Verifier, PM, QM, Approval signatures are all variants of the “sign” button and are seen
throughout the program.
The Choose File button allows the user to search for documents on his or her computer to attach
to a record. The attachment file Document Name link is available on the records once a file has
been attached. Selecting the hyperlink of the file name will prompt pop-up box for user to choose
what to do with selected file.
The Add Test button adds a line for tests methods and acceptance limits on the specifications
screen.
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The sort/filter selector: In the right collapsible search
panel there will be an option to organize the data on the grid. This drop down box allows
determining how the results will be sorted/filtered
The Show selector is available in the search panel on select
screens and filters for and shows only records that fall under the selected status.
Search /Clear: allows the user to search for records or to clear the current filters. There
are several possible scenarios regarding the use of the filters:
o If the user needs to find a particular record, s/he types the record name and clicks
search.
o If the user does not enter anything at all in the field, then the system will display all
available data, with a default of 50 records per page.
o If the user does not remember the complete record name, s/he can enter any part of it
and the system will search for all records which include the typed string.
o If there is more than one filter and the user enters data in more than one field, the
system will search information that matches ALL filters entered.
The Show drop down: shows only records with status of chosen option
The Data Grid: The area where data is displayed. In each line of the grid there may be
two or three controls:
o A hyperlink, indicated by blue text, which takes the user to the record detail.
o An Update pen Icon ( ) which allows the user to modify the record.
o In some cases there may be a version hyperlink; such as for a material or requisition
which will also be indicated by blue numbers. E.g.: Version: 2.
o The Copy (MPR versioning) icon can be seen on the MPR summary page and
makes a new, editable copy of the closed-out record.
o The version up icon allows user to make a sequentially numbered version of the
chosen MPR and can make changes to certain fields.
o The Scale up icon allows users to scale up the theoretical yield which automatically
scales up the BOM. If the auto populate button is checked, the scaled up amounts are
also transferred to the material action associated with the use of a material on
manufacturing instruction steps.
Note: The min and max are not automatically updated and should be checked.
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o User-selected data lists will include the choice to update or delete an item. The delete
icon will either instantly delete the record to bring up a pop-up screen asking user
to confirm the deletion. Select embedded tables have gray x’s for delete buttons.
o A printer icon to the left of completed records can be selected to print specific
records.
Data Entry “T” Screens
o Some screens will also include a material upload arrow which prompts a selection
list of materials to choose from as a separate pop-up screen. This icon can be seen on
MPR and BPR BOM pages, Project Definition, Manufacturing instruction Step, and
Requisition screens. These screens are data entry screens whose screen names always
begin with “T.”
o Blank checkboxes with dark blue outlines are available on several screens and
indicate that they can be selected; for example:
Note that some boxes (gray with gray checks) are visible from other screens, but they
can only be modified via screens whose names start with “T.” For example, the
HWWMaterialStatus screen shows a list of checkboxes whose statuses can only be
changed on the TMaterialStatus page after selecting the update pen icon.
The attachment file selection button appears on the Material receipt, Material status, MPR and
BPR cover pages as well as the manufacturing instructions of the MPR and BPR; It allows for
the attachment of a word, excel, jpg, or PDF file and is updatable (exceptions to update: after
MPR is locked, after receipt has been signed off and confirmed.) This button will allow the user
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to open existing attachments on material status, material use, material (bin) location, and MPR
and BPR covers.
The calendar icon allows the user to select a date from the calendar rather
than write it out.
Add Material Requisition button allows users to add lines to the requisition grid.
Change Location button allows users to change the location of a material vendor lot # via the bin
location.
The Update button appears on certain pages to allow the user to enter or change data on an
existing record.
The unlock function allows a QM user to unlock a previously locked BPR for the purpose of
adding memos regarding deviation investigations or adding stability data to an attachment.
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The Add Batch Inventory button allows the user to enter the amount of a finished batch produced
so that it can be tracked in inventory.
The Inventory button begins the workflow for a user to allocate use of a material in
real time during batch production via the batch record manufacturing steps or for more general
purposed via the inventory module. Bin location of material can also be accessed.
Manufacturing Process Overview
There are many QA checks and balances written into the program which guide an organized
workflow that follows Good Manufacturing Practices:
Starting a New Project
The checks and balances make quality a built in process that minimizes deviations and
omissions.
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Reference: SOP-101 Project Initiation
Optional features: Some features within InstantGMP are controlled in the background by the DBADM
dashboard. Contact your InstantGMP support specialist to toggle these features on and off:
1. QuickBooks Data Transfer tool 2. Ability to include FG and WIPs as ingredients in a Bill of Materials on the MPR. 3. Scanner Integration 4. Automatic Printing of Label on Receipt 5. Inventory Check Off 6. Specs Off (popular for VAPE) 7. Same person allowed on dual signature (popular for VAPE) 8. Medical Device View vs. MES view
Other optional features: 9. Increase user limit (contact [email protected]) 10. .Data import spreadsheet allows for import of vendor and material definitions (raw,
WIP and FG names) (visit instantgmp.com or contact specialist for excel file with instructions.)
STEP 1. Open your Instance of InstantGMP using your assigned Hyperlink to the secure
web address.
STEP 2. Sign in with your assigned UserID and password or with ADM user ID and
password to create a new user.
(This information is provided by InstantGMP support via email)
Through this option a user shall have the ability to insert, update and search Personnel. The password
must follow a medium password strength policy.
STEP 4. Select Update pen for ADM.
STEP 5. Enter your e-mail for ADM.
STEP 6. Confirm.
STEP 7. Select Add New Record button to create a new record.
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STEP 8. Enter First and Last Name (Project Manager)
STEP 9. Enter “pass1233” for a medium strength password
STEP 10. Select Project Manager role from the Default Job Function dropdown
STEP 11. The Administrator Rights Permission set is granted by clicking the checkbox
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STEP 12. Click
STEP 13. To add badge information click for the person and select a start date of no
later than current date and an end date of a year from now. (the badge scanner
option must be selected for on the dashboard for the feature to appear)
STEP 14. Repeat these steps for the Quality Manager role
Application Rules:
First Name and Last Name are mandatory.
Only Administrators shall have the authority to grant and revoke the Administration permissions
set. Only Project Managers should be designated as users with AR rights. Project Managers
should not give Administrative rights to any other roles unless the specific person is trained in the
complete application and their project duties include updating administrative information.
Anyone without the Administrator credentials is prevented from making any changes to screens
that are within the Administration menu and its sub-menus.
User ID is automatically assigned by the program with the following formula:
First letter of first name
First seven letters of last name
Sequential number starting with 01. (if Jane Doe were to be added next, she would be
JDoe02)
UserID is not case-sensitive
A password of medium strength is required; (must include alpha and numeric characters.)
Password is case sensitive.
The default Role can be assigned from the personnel screen. Personnel may login immediately
after role assignment on this screen.
After confirmation of the personnel screen, the option to create a badge is available on the
TPersonnel screen and the option to print the badge is available on the HWW screen.
Vendors
STEP 15. Navigate to: Setup Vendor
References: POL-0302 Vendor Selection and Qualification, SOP-212 Program to Qualify Vendors
Users have the ability to insert, update and search for Vendors.
Note: Manufacturer using IMGP must be listed in the vendor table. When FG or WIP materials
are to be produced using InstantGMP Batch records, the vendor list is selected from to identify
the vendor of that manufactured FG or WIP.
Note: The company name entered on the DBADM dashboard will automatically populate as the
first vendor.
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Note: Information other than Company Name is not mandatory and can be filled in at your
leisure
STEP 16. Click
STEP 17. Enter “Training-Great Raw Materials” as a vendor.
STEP 18. Click
Client
STEP 19. Navigate to: Setup Client
Note: A Client is any company ordering/funding projects, and/or represents clientele for whom
your firm does manufacturing, holding, packaging or private labeling.
Alternatively, your firm may be a Client who holds/packages/labels WIP/FG from other
suppliers whom you are mandated by the FDA to procure MPRs and BPRs from in efforts to
trace raw materials to customers and vice versa. There are different ways to set up MPRs
depending on your firm’s role in the process.
Note: The Company added on the Dashboard is automatically auto assigned as the first Client.
STEP 20. Click
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STEP 21. Enter Client Name: Training
STEP 22. Select “United States” from the Country drop down box.
STEP 23. Click
Material Types
STEP 24. Navigate to: Setup Material Types
References: POL-0303 Material Control Requirements, SOP-302 Material Types
Through this option a user shall have the ability to insert, update and search Material Types.
An effective Material Control system is essential to ensure that material and components are procured,
received, approved for use, labeled including expiry date, coded, stored, transported and dispensed
according to documented procedures when InstantGMP™ is used.
Note: These names will be the only items available in drop down boxes when material types need to be
selected and are essential to optimal organization of materials within InstantGMP.
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When new “Material Types” are entered into the system, they must be further classified with a
“System Type.” The three “System types” in the system are Raw Material “RM”, Incoming
Work in Process “iWIP”/Outgoing Work in Progress “oWIP” or Finished Goods “FG” This will
differentiate types of materials in other screens of the application where the system type is not
displayed. This will be important for searches for materials in other data base tables. Only
“Work in Process” or “Finished Goods” material types will appear when a Part # is needed in the
Project Definition screen. Material Types that have a system type of “Work in Process” or
‘Finished Goods” will not be editable. The screen does not have the “update” button available
for these types.
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STEP 25. Click
STEP 26. Enter “Raw Material” in the Material Type Name field
STEP 27. Select “Raw Material” from the Type drop down box
STEP 28. Click
STEP 29. Click
STEP 30. Enter “Packaging” in the Material Type Name field
STEP 31. Select Raw Material from the Type drop down box
STEP 32. Click and repeat steps for the material types that apply to your
operation.
Note: Finished Goods is a preset option and does not need to be entered; however, customization
such as “Encapsulated Finished Goods” can be created for convenience.
Material Status
STEP 33. Navigate to: Setup Material Status
References: POL-0303 Material Control Requirements, SOP-304 Material Status
Through this option a user shall have the ability to insert, update and search Material Status.
Application Rules:
The system will always maintain the material statuses "Quarantine", "Approved" and “Rejected”
which cannot be deleted.
The system will allow entry of other material statuses.
If the “System Status” check box is selected, it locks the “Material Status” name which can then
not be updated, changed or deleted. If the checkbox is not checked, the user can update the
material status at a later time.
Anyone with Administrator rights can check the System Status box and lock in a custom name
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and Status indicator (Quarantine/Approved.) This ensures that should a custom status be created,
it will always be identified to a root Status; e.g. “QA retains; Quarantine” or “Ready for Shipping;
Approved.”
Note: “Is Quarantine” is used as a default to define the status when an incoming material is first
received or internally produced WIP of FG is logged into the inventory after production.
A Material Status of “Is Quarantine” prevents the material from being used in a production batch.
Only the material types in this screen will appear in drop down boxes for material approvals.
Optional: steps 29 – 36, adding customized Material Statuses.
STEP 34. Click
STEP 35. Enter “FG Retains/Stability” in the Material Status field
STEP 36. Select the “Is Quarantine” checkbox
STEP 37. Click
STEP 38. Click
STEP 39. Enter “Approved for R/D” in the Status field
STEP 40. Check the box for “Is Approved”
STEP 41. Click
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Storage Condition
STEP 42. Navigate to: Setup Storage Condition
Reference: SOP-412 Environmental Chambers and Storage
Note: “Storage Conditions” refer to the conditions that are available in the facility covered by an
instance of the data base. Only the storage conditions in this screen will appear in drop down boxes
when storage conditions have to be specified.
Through this option a user has the ability to insert, update and search Storage Conditions.
If there are stability chambers, cold rooms and warehouses, each condition should be entered.
The Storage Condition Name is a unique and required field.
STEP 43. Click for the “Ambient” selection.
STEP 44. If your facility has specifications for ambient room temperature such as: 18 C
45%RH, or 68-73 F, 44% RH, enter it here. If not, make no changes.
STEP 45. Click
Unit
STEP 46. Navigate to: Setup Unit
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“Unit” refers to units of measure that will be used in the purchasing of materials and in creating batch
formulas. The unit conversion feature enables the operators to purchase material in larger quantities (e.g.:
kg) and deplete the inventory in smaller quantities (e.g.: g).
Application Rules:
Only the units in this screen will appear in drop down boxes when units have to be specified.
Additional static units may be added by selecting the insert button and confirming a new
entry. These units will not be interchangeable nor will they convert from or to any other
unit.
The Unit Name is a unique and required field. (this only applies to additionally added units, which
for most companies is not necessary.)
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Facility
STEP 47. Navigate to: Setup Facility
Reference: SOP-404.01 Facility Start-Up and Shut-Down, SOP-401.01 Performance
Qualification of Systems (PQ), SOP-402.01 Facility Access and Security, SOP-403.01
Warehouse and Production Area Cleaning and Maintenance.
“Facility” refers to the buildings/Campuses where manufacturing/holding/packaging is to be
tracked in a single instance of InstantGMP software system. Through this option a user has the
ability to insert, update and search Facilities.
System Rules:
Only the facilities entered on this screen will appear in drop down boxes for specifying
facilities.
The Facility Name is a unique field.
STEP 48. Click
STEP 49. Enter Facility name “Training-Manufacturing Site”
STEP 50. Click
Room
STEP 51. Navigate to: Setup Room
References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and
Facility, SOP-406.01 Equipment and Room Logs and Status Tagging
Through this option a user shall have the ability to insert, edit and search Rooms.
Room refers to any numbered room or designated space used for storage/holding, processing or
packaging of materials and components, as well as any spaces used to support or facilitate those
functions or processes documented in InstantGMP. (e.g. weigh room, airlock, gowning room,
controlled hallways, etc.)
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Application Rules:
Only the rooms entered via this screen will appear in drop down boxes when rooms have
to be specified.
Every Room must be linked to a Facility. This is implemented via mandatory selection of
a Facility from a drop-down box to define a room.
Room number must be unique per facility. Room names can be used multiple times.
STEP 52. Click
STEP 53. Select “Training-Manufacturing Site” from the Facility drop down box.
STEP 54. Enter the room number 99900 and room name Z -Training
STEP 55. Click
Bin Location
STEP 56. Navigate to: Setup Bin Location
References: SOP: 420 Facility Maintenance and Modifications
Application Rules: Facility must be unique and is required.
STEP 57. Click
STEP 58. Select “Training-Manufacturing Site” from the Facility drop down box.
STEP 59. Select “99900-Z -Training”
STEP 60. Enter “102” for Bin Number
STEP 61. Enter “Samples” for Bin Location
STEP 62. Click
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Equipment
STEP 63. Navigate to: Setup Equipment
References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-
406.01 Equipment and Room Logs and Status Tagging
Through this option a user has the ability to insert, edit and search Equipment. The Equipment Code is a
unique field entered by the user.
Application Rules:
Only the equipment in this list will appear in drop down boxes when equipment has to be specified.
Equipment name and number are mandatory
STEP 64. Click
STEP 65. Enter in Equipment Number “999999” and Equipment Name “Training - Equip”
(required fields.) Add arbitrary numbers to model and serial number. Select
calendar and current date for due dates.
STEP 66. Click
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Tests
STEP 67. Navigate to: Setup Tests
Reference: SOP-215.00 Tests
“Tests” are the titles of the attributes, quantitative or qualitative, that will be used to determine whether
materials in question are in compliance with specifications. A Test names what is being tested for.
Application Rules:
Through this option a user shall have the ability to insert, update and search Tests.
Only the tests entered in this screen will appear in drop down boxes when tests have to be specified.
The Test Name is a unique field.
STEP 68. Click
STEP 69. Enter “Micro”
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STEP 70. Click
STEP 71. Repeat steps for more tests if applicable to your operation
Methods
STEP 72. Navigate to: Setup Methods
Reference: SOP-216.00 Methods
Application Rules:
“Methods” are the actual procedures that will be used when testing of materials is
required to show the materials are in compliance with specifications. A method is How to
test.
Through this option a user shall have the ability to insert, update and search Methods.
Only the methods confirmed via this screen will appear in drop down boxes when
methods have to be specified
The Method Name is a unique field.
STEP 73. Click
STEP 74. Enter Method associated with a test. “USP (62)” Note: a specific SOP #, procedure
#, or Assay name could be used here as well.
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STEP 75. Click
STEP 76. Repeat steps for more Methods that are applicable to your operation
Countries
STEP 77. Navigate to: Setup Countries
“Countries” identify locations where manufacturing/holding/packaging/labeling facilities are
located or where personnel are based.
Application Rules:
Only the countries in this screen will appear in drop down boxes when countries have to
be specified.
Through this option a user shall have the ability to insert, update and search Countries.
The Country Name is a unique and required field.
STEP 78. Click
STEP 79. Enter Country name. “UK”
STEP 80. Click
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Material
STEP 81. Navigate to: Materials
References: S308 Part # Assignment and POL-0208 Project Initiation
Through this option a user has the ability to insert, update, and search Materials.
“Materials” are parts and components for manufacturing or the products of manufacturing.
Material Classifications separate these two types of materials for ease and organization:
Incoming raw materials, components, packaging and labelling and incoming WIPs
Vs.
Outgoing WIPs and finished Goods (in house WIP counts as outgoing since it is manufactured
Note: The components, excipients, raw materials, incoming and outgoing work in processes and
finished goods WIPs are materials that are either ordered for further use in production,
precursors to products to be manufactured in-house or shipped to be further processed elsewhere.
Example: bulk powder herbal blends are FG for the blend manufacturer but are Raw Material for
the encapsulator. For the encapsulator, bulk capsules are WIP if packaging is done in-house or
FG if sent to a third party.
Application Rules:
Materials should only be ordered from approved/qualified vendors; see business rules on
Vendor Qualification.
Note: InstantGMP and applicable SOPs assume that all materials ordered are from
qualified vendors according to SOP-0212 – Program to Qualify Vendors.
The Part Number is a read-only and auto-numbered field assigned by the application
Material Name is a unique field. An error message will be displayed if a duplicate is
entered.
Products to be manufactured are automatically assigned Part #’s by the system prior to
production so these materials can be tracked by the system prior to and after
manufacturing.
Material Classification, Material Name, Type, Unit and Storage Condition are required
fields.
The Material Name will be a read only field after it is created.
In the Material Update screen shown below, the Material name cannot be edited.
Vendor number is akin to a catalogue number from a vendor; individual lot numbers are
entered later.
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The application will alert user with red error messages when any mandatory field has
been overlooked.
The selected Unit for outgoing materials should represent the Material units
required when creating the batch.
o Note: Take time to consider ordering unit, densities used in any calculations and
unit of sale item. This is a crucial step of the organizational process that can save
you consulting hours in the long run.
The search panel on the right includes a search for part #, material name, material ID and a filter
for Material type.
STEP 82. Click
STEP 83. Select “Raw Material/In-Coming WIP/Other” Material Classification
STEP 84. Click
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STEP 85. (Mandatory) Select the (Material Type) “Ingredient-RM” (See Figure 21)
STEP 86. (Mandatory) Enter the Material Name “Training-Raw Powder”
STEP 87. (Mandatory) Select the unit of measure associated with the material. “g”
STEP 88. Enter the Material ID “Training Raw 1”
STEP 89. Enter the Material Description “Fine white powder”
STEP 90. (Mandatory) Select Storage conditions from the dropdown box. “Ambient”
STEP 91. Enter a shelf life (based on stability studies, the limiting ingredients’ expiration date
or a default standard) “12 months”
STEP 92. Enter QM retest period (based on QA retain or stability test specifications) “12.000”
STEP 93. Enter a vendor order number if known (static number used from a supplier to
represent that material): “TrainingGRM-1”
STEP 94. Select Vendor from the dropdown box. “Training-Great Raw Materials” (Select
your own company for products produced or packaged in-house)
STEP 95. Click
STEP 96. Repeat steps 81 through 91 for “Training-Capsules” (See Figure 21)
STEP 97. Repeat steps 81 through 91 for “Training-Container” (See Figure 21)
STEP 98. Repeat steps 81 through 91 for “Finished Encapsulated Product FG” (See Figure
21)
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Note: For this material’s Select Material Classification Use “Finished Good/Outgoing WIP”
Material Type Ingredient-RM Component-RM Primary
Container-RM
Packaged/Labeled-
FG
Material Name Training-Raw
Powder
Training-
Capsules
Training-
Container
Finished
Encapsulated
Product FG
Unit g ea ea kg
Material ID Training Raw 1 Training Raw 2 Training PC Training Finish
Material
Description Fine white powder Clear, no band
vegetarian gel
White plastic
bottle
Encapsulated
Powder
Storage
Condition Ambient Ambient Ambient Ambient
Recommended
Shelf Life 12 months 12 months 120 months 12 months
QM Retest
Period 12 3 12 3
Vendor Order
Number TrainingGRM-1 TrainingGRM-2 TrainingHDPE
Vendor Training Great
Raw Materials Training Great
Raw Materials
Training Great
Raw Materials
Figure 21
Note: Confirmation will return user to the HWWMaterial screen with a summary of all materials
confirmed.
Material Specifications
Specifications for Raw materials including any components, labels, etc. or incoming WIPs may
be any tests completed to prove the purity, strength, identity or general physical properties and
fitness for use in production. This also includes any visual comparison to a known standard as
well as other organoleptic methods.
Specifications for outgoing WIPs and FGs produced in-house may also have specifications for
final purity and strength, retain and stability testing and in-process testing such as fill volumes or
weights of capsules, pH, uniformity of color or viscosity, inspection of containers, closures,
packaging and labelling, among others.
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STEP 99. Navigate to: Specification
The Material Specifications page “HWWSpecification” screen shows all specifications, allowing
for filtering for “Approved,” “Pending Approval” and “All.”
Application Rules:
The record is automatically assigned a sequential version number.
A user has the capability to insert, update and delete tests/methods/etc. for a Material
Specification until both the PM and the QA signatures are confirmed. No further changes
can be made after the PM and QM approvals are confirmed.
Part #s with an update icon indicate that the material specifications have not yet been
approved and locked.
A version 2 cannot be created until the version 1 signatures have been confirmed.
(A part # whose specification is open (not locked) will not appear on the “Select Part # to
version Up” screen (and a new specification version cannot be created) because the prior
version has not yet been approved and is still editable.) Open records will only appear on
the HWWMaterialspecification screen and can be seen by filtering for “pending
approval” or “ALL”
QM and PM approval is necessary for the Material to be used in the Bill of Materials of
an MPR, inventory, or projects.
If a material needs different specifications for different uses (e.g. lactose in a liquid
product vs. lactose in a powder product), a new material part number must be created and
assigned unique specifications.
Different versions of a material specification may be used concurrently in different MPRs
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This list is comprised of materials with specifications still pending one or more signatures and
materials for which specifications are completed and locked down.
Note: if you expected to see records on this screen but do not, select filter in the right collapsible
panel, for “ALL” to display those records.
STEP 100. Click to create new specification.
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This list is comprised of new materials without specs assigned and materials with signed off specs
for which a new specification record can be generated. If a material does not appear on this list, the
material has an open record that needs to be edited and/or signed. To access open records, select
the “Cancel” button to return to the hub screen and filter for “Pending Approval” or “All.”
Records with update arrows can be modified and signed and locked.
STEP 101. To create version 1, Click the for the “Training-Raw Powder” Material.
Note: Even if no data is entered, confirming creation of this record will move the record to the
HWWSpecifications screen for in process records awaiting approval.
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STEP 102. Enter the effective date or current date of the test specifications for the material.
STEP 103. Enter the MSDS/ Safety and Handling Data “Wear gloves and mask; handle and
store in cool dry environment”
STEP 104. Enter General Sampling instructions for the material “Use plastic scoop #3 to
aliquot 5 grams into each of three plastic sample jars. Secure lid and label”
STEP 105. Click Add test button
STEP 106. Select test “Micro” from drop down.
STEP 107. Select Method “USP <62>” from drop down.
STEP 108. Enter a Acceptance limit of “<0 CFU”
STEP 109. Enter a Sampling of “In Process Visual”
STEP 110. Select the box for Required for Release
Note: The box for release indicates that the test in question is required to meet specs before the material
or product is released for R&D, production use, distribution or sale.
STEP 111. Click
STEP 112. Log out
STEP 113. Login as PManager01
STEP 114. Select Signature prompt for Project Manager/Project Supervisor
STEP 115. Click
STEP 116. Log out
STEP 117. Log in as QManager01
STEP 118. Select Signature prompt for Quality Manager
STEP 119. Click
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STEP 120. Repeat steps for the remaining material part #s in order to set and approve
specifications for all materials needed for production including the finished good product:
Material Name Training - Capsules Training-Container Finished Encapsulated
Product FG
Effective Date Use current date Use current date Use current date
Safety/Handling Don gloves, keep cool
and dry
Don gloves, keep cool
and dry
Don gloves, keep cool
and dry
Sample Instructions Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
tests Select a test and method
from drop down
Select a test and method
from drop down
Select a test and
method from drop
down
STEP 121.
Note: A New sequential version (2) may be created by clicking the hyperlink for part number on
the version up screen and repeating steps for a part number with an approved specification
version 1. Reason for change is required.
Creating a Project
Application Rules:
Your firm should be entered as a Client as well as a Vendor; this may be accomplished in
one step by having your support specialist (the DBADM) enter your company into the
“Company” field on the DataBaseADMinistrator dashboard.
Project Definition
STEP 122. Navigate to: Project
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STEP 123. Click
Application Rules:
The Project Title is a unique and required field.
The Project Title is read only once the Project is created.
Only parts that are “oWIP” or “Finished Goods” can be selected in the Part Number field.
Multiple part numbers may be selected for a single project.
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Multiple products built on the same part number are allowed per project
STEP 124. Enter the Project Title “Training -Finished Encapsulated Product”
STEP 125. Enter a Project description (optional)
STEP 126. Select WIP/FG Part # Tab
STEP 127. Click
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STEP 128. Click for “Training - Finished Encapsulated Product FG”
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STEP 129. Enter Strength
STEP 130. Click for the Primary Container part # selection list
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STEP 131. Select the hyperlink for the Primary container
STEP 132. Enter a Product Name Suffix (optional)
STEP 133. Click
STEP 134. Select the Client tab
STEP 135. Add secondary client if applicable
STEP 136. Select the Personnel tab
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Note: Delete personnel from the project or add personnel to the project using
button
STEP 137. Click to add a secondary role for the PM
Application Rules:
Each person must be assigned a Job Function in order to log into the application. (Until a
primary role is assigned on the TPersonnel screen,, the application has no permission
boundaries set for that person; the default is no permission set and the person cannot get
to the main menu) See Personnel page for other options.
Personnel can be assigned different roles for different projects.
Personnel can be assigned multiple roles per project.
A person can be an MPR Approver and/or a BPR Approver, or neither.
Each Project should have at least one MPR and at least one BPR approver assigned.
STEP 138. Click
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STEP 139. Select Quality Manager role from the drop down
STEP 140. Click
STEP 141. Select update icon for PManager01
STEP 142. Select the MPR and BPR checkboxes
STEP 143. Click
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Requisitions
STEP 144. Navigate to: Requisitions
Through this option a user can create a material requisition with multiple materials from the
same vendor.
Application Rules:
The system will allow a user to build a requisition using materials from a single vendor.
One and only one vendor is identified per requisition.
Only approved Material Specification versions will appear in selection list
The Part Number, Unit, and Qty fields are required fields for each line of the requisition.
Unit chosen must be equivalent to or convertible to the unit assigned to part # on Material
page
Amounts ordered for a material requisition can be converted to other units within that
unit system but cannot be converted from weight to volume or vice versa.
The system will assign a unique requisition number for each requisition created.
Once a Requisition is signed and confirmed it cannot be edited. The system will display a
print icon yielding a PDF version of the requisition
No update icon will be displayed when the record is no longer editable.
STEP 145. Click
STEP 146. Select the Vendor “Training-Great Raw Materials”
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STEP 147. Select needed by date (Today’s date)
STEP 148. Click
The Select Material Specification pop up will appear
STEP 149. Select “Training - Raw Powder” (popup is closed automatically
STEP 150. Enter Qty “3.010”
STEP 151. Select the unit kg from the unit drop down box.
If not already present, Enter “TrainingGRM-1” in the Vendor Order Number field.
STEP 152. Make sure to check the boxes for MSDS and COA. (Material Safety Data Sheets
and Certificate of Analysis)
STEP 153. Click
Repeat steps 142 through 147 for Vegetarian Capsules as seen below:
STEP 154. Click at the bottom of the page
STEP 155. Enter credentials and confirm.
STEP 156. Click
Vendor Material Name Unit Quantity Vendor Part
Training Great
Raw Materials
Training Raw
Powder
kg 3.010 Training-
GRM-1
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Training Great
Raw Materials
Training
Capsules -
Vegetarian
ea 1000 Training -
GRM-2
Training Great
Raw Materials
Primary
container
ea 100 TrainingHDPE
STEP 157. Select the printer icon on the requisition screen.
STEP 158. Print and or email electronic copy of the Requisition Order to Project Manager.
(Functionality will depend on version of Adobe)
Regardless of the accompanying software, the printout will appear as below:
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Inventory
This module includes Receipt, Status update and Use of a material.
Material Receipt
STEP 159. Navigate to: Inventory Material Receipt
Application Rules:
For each line (Part #/Material) of a requisition order, the system shall create a unique
Receipt Number for each material received per requisition which is auto-numbered and
read-only. This number is created at the time of requisition confirmation.
A digital signature is required to save a material receipt record.
The system will allow a user to record the receipt of a specified quantity of material,
which is added to the inventory upon confirmation of signature.
The system will allow a user to search for a material based on either Part Number,
Receipt Number, requisition number or material name.
The system will allow a user to record inventory usage details for each receipt number in
the system.
Through this option a user can search all the material that was ordered and ready to be
received as well as any partial records awaiting signature confirmation.
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 160. Click for a part number to receive
STEP 161. Select the MSDS and COA checkboxes indicating that the data was received.
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 162. Enter the Qty received 3.010
STEP 163. Select the unit received
STEP 164. Enter Vendor lot # “Training 2,” representing the specific lot received.
STEP 165. Select calendar icon and select today’s date for date received.
STEP 166. Select calendar icon for “Use by” date; select one year from now by selecting double
arrow icon and selecting date.
STEP 167. Attach any COAs or MSDSs via the “Choose File” buttons.
STEP 168. Click
STEP 169. Enter credentials
STEP 170. Click
STEP 171. Repeat steps for the remaining part number receipt Vegetarian Capsules.
Vegetarian Capsules Primary Container
Qty Rcv 1000 100
Units ea ea
Vendor Lot Number Training-GRM 2 TrainingHDPE
Date Received Use current date Use current date
Use By One year from current
date
One year from current
date
Application Rules:
Qty received, date received and vendor lot number are required fields
Upon confirmation of a material receipt record, that receipt# is no longer available on the
receipt screen
Upon confirmation of a material receipt, the record becomes available in the Material
Status section with a default status of “Quarantine” and on the Material use screen.
Inventory Status
STEP 172. Navigate to: Inventory Inventory Status
Application Rules:
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Only a Quality Manager (or inventory manager in the INV system) can change the status
of received inventory.
Any updates require a digital signature and will always display the UserID/time/date
stamp from the latest confirmed update.
The default value for all materials is Quarantine.
The Inventory Status screenshot shows the record created for a material received.
STEP 173. Select the Receipt number hyperlink
STEP 174. Logout and log back in as a QM OR toggle to the QM role in the upper right hand
corner of the application.
STEP 175. Click
STEP 176. Expand the Status drop down box and select Approved
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 177. You will be redirect to a page to enter credentials and confirm
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 178. Write “Training- All tests passed, see attachment” in the comment field
STEP 179. Select the browse button and attach a document to represent test results.
Note: the hyperlinked file names can be selected to bring up an open/save window for the previously
attached document.
STEP 180. Click
STEP 181. Repeat steps for Vegetarian Capsules and Primary Container.
Inventory Management
STEP 182. Navigate to: Inventory Inventory Management
Application Rules
Once a material is received in Material Receipt, the received quantity is populated in the
Quantity Rcv field expressed in units from receipt screen.
Qty remain will be expressed in units from the Tmaterial screen
A record will be created for each Material received in Material Receipt
A quantity greater than zero must be entered..
A user shall have the capability to remove/deduct (edit) material amount from each
Material Receipt Line with Quantity available.
The system will display the history of inventory usage records and the inventory balance
for each receipt number.
The system will allow a user to enter an inventory usage record using convertible units
(i.e.: g/mg; mL/L) and properly record the inventory balance in the default unit for that
receipt.The Project Manager will need to reconcile the inventory manually if multiple
sub-shipments of a material with the same lot number are received in the same day. If a
material is received on a single receipt with multiple sub-lots with different lot numbers
(split lots), then the Project Manager will have to create another requisition and a
subsequent receipt for each of the sub-lots.
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 183. Select the receipt number hyperlink for a part number.
STEP 184. Click
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 185. Enter “1.0” in the Quantity Used field
STEP 186. Select “g” from the Unit drop down box
STEP 187. Enter “Training Exercise- Testing” in the Purpose box
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 188. Click
STEP 189. Enter credentials and confirm
Optional: Select gray attachment button or attach another document.
STEP 190. Click
Inventory Location
Inventory Location allows users to assign and change the location of an entire material receipt’s
vendor lot#/material/amount/unit via the bin location tied to a facility and room.
STEP 191. Click receipt hyperlink for material
STEP 192. Click
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 193. Select the Facility, Room and Bin Location from the drop downs
STEP 194. Sign and Confirm
Depleted Inventory
STEP 195. Navigate to: Inventory Depleted Inventory
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Application Rules
Materials with a 0 balance will be in this list.
The page is Read Only.
Through this option a user can view, order and search all the Material Receipt lines with
no Quantity available.
STEP 196. Navigate to: Logs Room Log
Through this option a user shall have the ability to insert, update and view the log entries of the
Rooms and Equipment defined on the corresponding Administration screens.
Note: The room name can be a number.
STEP 197. Select Room # hyperlink for Facility
STEP 198. Click Enter:
Facility Training - Manufacturing Site Room Name Z - Training Activity Room Cleaning Cleaning Agent, Lot # Alcohol solution, Lot #222 Prod Name or Part # n/a Batch n/a Temperature 18 C Relative Humidity 45% Comments Room cleaned according to SOP CLN-002
Note: Temperature and humidity are only relevant if the room is supposed to be controlled.
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 199. Select Operator Sign button, enter credentials and confirm.
STEP 200. Sign in as a QM
STEP 201. Select Review signature button, enter credentials and confirm.
STEP 202. Click
STEP 203. Navigate to: Logs Equipment Log
Equipment Log screen:
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Note: Start Date, End Date, Cleaning Agent, Product Name or Part # and batch refer to the
previous batch run in the equipment unless the cleaning is a periodic cleaning or not associated
with a batch. This is controlled by your facility’s SOPs.
Note: Equipment numbering convention to consider: YYY-XXX where YYY is the alphabetic
acronym for the equipment and XXX is the sequential number of that type of equipment for that
specific item.
STEP 204. Select Hyperlink for Equipment number
STEP 205. Click
STEP 206. Enter data as shown below:
Equipment Number a Equipment x Activity Calibration Start Date/Time Use current date and time End Date/Time Add 4 hours to above Cleaning Agent, Lot # n/a Prod Name or Part # n/a Batch n/a Comments Equipment calibrated according to Equipment SOP
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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STEP 207. Have an Operator and Project Manager each sign for the activity.
STEP 208. Click
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Master Batch Records
STEP 209. Navigate to: Batch Record -Master Production Record
Through this option a user can add, edit, view, search, sort and hide, copy, version up, scale up
and print Master Production Records or Master Device Records.
To use the new Hide function, select the checkbox for those records you want hidden and confirm. To see
those records, select “Hidden” from the search Status drop down as search. To see only active records