Good Manufacturing Practices and InstantGMP Overview
Good Manufacturing Practices and InstantGMP
Overview
Topics
Batch Production Record Workflow• Purchasing • Material Receipt• Batch Production• Inventory• Summary
Overview• Purpose of GMPs• Quality Systems• GMP Process Flow
Master Production Record Workflow• Materials• Products to be
manufactured• Specifications• Master Production
Records
InstantGMP Quick Facts
• Web application hosted in the cloud• Team of GMP manufacturing and quality experts used to guide
software development• 21 CFR Part 11, GAMP 5 and FDA validation requirements met• Standard Operating Procedures for a GMP facility and software
written as part of the software development• Software has been in use since 2004
Quality System
• Quality = meeting specifications• Quality Control = testing to ensure specifications are met• Quality Assurance = review of testing results and promotion of
practices intended to ensure quality• Quality System – policies, standard operating procedures and other
documentation that define the practices needed to ensure quality • Good Manufacturing Practices lay the foundation for a quality system
Purpose of Good Manufacturing Practices
Following FDA requirements for
Good Manufacturing Practices
Gives you consistent, high quality products
Implementing Good Manufacturing Practicesfrom Start to Finish
FDA Requirements
Consistent, high quality products
Quality System
GMP Interpretation
Policies and SOPs
Training
FDA Requires SOPs for GMP Compliance
InstantGMP SOP Sets
• Full Set• 93 SOPs and Policies that provides a quality system for any GMP
manufacturing site
• Core set • 30 SOPs and Policies cover the basics of manufacturing with InstantGMP™
MES
• Holding and Distribution Set• 65 SOPs and Policies that provides a quality system for any Holding and
Distribution company that must comply with GMPs
Who Must Follow cGMPs?Drugs and Medical
DevicesDietary Supplements Food and
CosmeticsFirms that manufacture and send out for packaging and labeling or import for sale any product that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body
Firms that manufacture and send out for packaging and labeling or import for sale any dietary supplement product
Does not apply to dietary ingredients
Food processors and distributors
Firms that manufacture, package or label cosmetics
10
Basic Tenants of GMPs
• Instructions and procedures are clear and unambiguous• Manufacturing processes are clearly defined and controlled • Facilities are designed to minimize cross-contamination and mix-
ups• Operators are trained• Records demonstrate that all required steps were taken • Distribution minimizes any risk• Manufacturing is governed by a Quality System consisting of
Policies and SOPs
FDA Mantra: “If it wasn’t documented, it wasn’t done!”
Good Manufacturing Practices Work Flows Reinforced in InstantGMP
Enter products to be manufactured
Enter materials needed for manufacturing
Establish material and product specifications
Requisition materials and components
Receive materials into inventory and approve for use
Prepare Master Production Record Add batch to inventory
Master Production Record Work Flow
Generate Batch Production Record
Batch Production Record Work Flow
Organize Products into Projects Capture production data
Three Components of a Quality System are:Policies - Describe what is needed to be in GMP compliance
Standard Operating Procedures – Implement the workflow required by the policies
Documentation required by SOPs - Record in InstantGMP
Quick Discussion
• Are any of these concepts new to you?• What do you think using a quality system will do for you personally?
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Good Manufacturing Practices and InstantGMP
Master Production Record Workflow
Good Manufacturing Practices Work Flows Reinforced in InstantGMP
Enter products to be manufactured
Enter materials needed for manufacturing
Establish material and product specifications
Requisition materials and components
Receive materials into inventory and approve for use
Prepare Master Batch Record
Add batch to inventory
Master Production Record Work Flow
Generate Batch Production Record and capture production data
Batch Production Record Work Flow
Materials
• Two classifications of materials:• Materials used in manufacturing
• Raw Material• Incoming WIP• Other
• Materials that are manufactured• Outgoing WIP• Finished Goods
• Each Classification has a different input screen
Materials used in manufacturing
• Default types provided in InstantGMP
• Part # automatically assigned
• Material ID captures legacy numbering system
Materials that are manufactured
• Products used in creating an MPR
-Finished Good-Outgoing WIP
System Generated Numbers
Warehouse Receiving
Purchase Order
Material
Part #
Requisition #
Receipt #
Specification w/Version #
Master Record w/Version #
Batch #
Production
Master Record
Specifications
InstantGMP automatically assigns
and tracks Part #s
Specifications
• Establish the basis of quality for your final product• Make sure you are getting the right materials from your vendors• Ensure you have the right ingredients in the product• Keep contaminants from adulterating a batch• Allow you to verify identity, purity, strength and composition
Spec
ifica
tions
Needed
Fo
r:
•Com
ponents
•In-process production
•Labels and packaging
•Finished batch of product
•Packaging and labels
•Product you receive from
a supplier for packaging and labeling
System Generated Numbers
Warehouse Receiving
Purchase Order
Material
Part #
Requisition #
Receipt #
Specification w/Version #
Master Record w/Version #
Batch #
Production
Master Record
Specifications
InstantGMP automatically adds specification version
numbers
InstantGMP Specification Entry Screen
Specifications have to be approved before material can be ordered or used in a batch
Example:
InstantGMP Specification Entry Screen
Each specification must have tests, methods and acceptance limits
Example:
Projects
Add a WIP/FG to a Project
1. Click Add WIP/FG Part # 2. Select a Material Name
Only FG and oWIP (outgoing WIP)show in the list
Add a WIP/FG to a Project
• Material Name + Strength + Container + Suffix must be a unique combination for each Product Name• Strength, Container and
Suffix are optional
3. Create a Product Name
Add / Delete a WIP/FG in a Project
• Multiple products can be added to any project• Product can be modified or
deleted up until the product is used in an approved MPR
Creating a new MPR• Project/Product/Client
combination creates flexibility• Strength is inherited from
Product Name• Batch Unit is inherited
from Tmaterial• Unique for each MPR
lineage of versions• Product Name/Strength• Client• Formulation ID• Theoretical Batch Yield• Batch UnitDefinitions of “Theoretical Batch Yield” and “Batch Size” added
MPR Versioning
• Each new MPR version will be a copy that can be edited except for the following that will be kept constant:• Product Name/Strength• Client• Formulation ID• Theoretical Batch Yield• Batch Unit
MPR Status Definitions
• Approved• All approvers signed• BRP can be made from MPR
• In-Process• No approvers signed• MPR can still be edited
• Locked• At least one approver, but not all
signed
• Rejected• One approver rejected MPR
MPR Copy
• Only Approved or Rejected MPRs can be copied• All information is copied and is
editable• At least one of the following must
change (to qualify as a copy not a version up):• Product Name• Strength• Formulation ID• Theoretical Batch Yield• Batch Unit
MPR Version Up
• Only Approved or Rejected MPRs can be “Versioned Up”• All information is copied and is
editable except the following:• Product Name• Strength• Formulation ID• Theoretical Batch Yield & Unit• Materials
• “Reason for Change” is required field on MPR Cover page
MPR Scale Up/Down
• Only Approved or Rejected MPRs where the BOM QTY is checked can be scaled
• All information is copied and is editable except the following:• Product Name• Strength• Formulation ID• Batch Unit• Materials
• Quantities in BOM and mfg instructions will be calculated based on new Theoretical Batch Yields
• Version will be 1 and MPR will be unique
Master Production Record
• MPR Tabs• Cover Page – Product
Description• Materials• Equipment• In-Process Tests• Manufacturing
Instructions• MPR Approvals
Find articles and videos on cGMP compliance and quality in the Resource
Center at InstantGMP.com
Good Manufacturing Practices and InstantGMP
Batch Production Record Workflow
Good Manufacturing Practices Work Flows Reinforced in InstantGMP
Enter products to be manufactured
Enter materials needed for manufacturing
Establish material and product specifications
Requisition materials and components
Receive materials into inventory and approve for use
Prepare Master Batch Record
Add batch to inventory
Master Production Record Work Flow
Generate Batch Production Record and capture production data
Batch Production Record Work Flow
Requisitions
• Materials and components must come from qualified vendors• Materials and components must have specifications approved by the
Quality Unit• All chemicals need a Material Safety Data Sheets (MSDS) on file• Certificate of Analysis (COA) is needed for each material to be used in
manufacturing a product• Incoming materials must be same material and same grade as
specified on purchase order
InstantGMP Requisition Screen
Example:
Material Receipt
• Identify each lot # of material received and each lot of manufactured product• Connect the material
lot # to the supplier and to each manufactured product
System Generated Numbers
Warehouse Receiving
Purchase Order
Material
Part #
Requisition #
Receipt #
Specification w/Version #
Master Record w/Version #
Batch #
Production
Master Record
Specifications
InstantGMP automatically
connects Part #, Lot # and Receipt #
Why
Ba
tch
Re
co
rds
ar
e
Impo
rtan
t
•Show
s when product w
as produced
•D
ocuments actual tim
es of procedures and am
ounts of m
aterials used; etc.
•Assures consistency in how
processes are follow
ed
•Enforces uniform
ity and quality
•Identifies the source of m
aterial if adulteration is discovered
InstantGMP automatically
assigns Batch #s
System Generated Numbers
Warehouse Receiving
Purchase Order
Material
Part #
Requisition #
Receipt #
Specification w/Version #
Master Record w/Version #
Batch #
Production
Master Record
Specifications
InstantGMP Batch Production Record
• BPR Tabs• Cover Page – Product
Description• Materials• Equipment• In-Process Tests• Manufacturing
Instructions• BPR Review
InstantGMP Batch Production Record Instructions Screen
Quick Discussion
• Does your company have both master records and batch records?• What do you see might be a challenge in using electronic batch
records?
Distribution Procedures
• Products should only be shipped out for distribution after they have been released by the quality unit• Products should be transported in a way that maintains their quality• Special transport or storage conditions should be stated on the label• A system should readily permit the recall of a product if needed
Tracking of Inventory DistributionExample:
Summary
• Good Manufacturing Practices are complex and thorough• Wide array of regulatory requirements need to be followed• Following GMPs gives you high quality products• InstantGMP guides you through the GMP manufacturing process
Remember the FDA mantra: “If it wasn’t documented, it wasn’t done!”
Quick Discussion
• What concepts have you learned that you weren't aware of before?• What part of InstantGMP do you anticipate you will need support to
implement?
Next Training Sessions
• Software Training (2 hours) – An interactive introduction of the InstantGMP software to the Project Manager (PM) and Quality Manager (QM). Product specific or company specific questions will be addressed during the Dry Run.• Dry Run Preparation - An instruction session where PM and QM will
learn about naming conventions and what information is needed to fill out the Dry Run Preparation spreadsheet. • Dry Run (2 X 2 hours) –The PM and QM will draft a Master Production
Record and practice manufacturing the product from the Dry Run Spreadsheet. This will prepare the PM and QM to enter products on their own.
Training Scheduling
• Designate one Project Manager and one Quality Manger who can commit to the full training program. • These are the only people who will receive Software Training and Dry Run practice• Training so they will need to attend all technical training sessions.
• Your subscription includes these 8 hours of training time• If scheduled training needs to be changed, let us know 24 hours in advance,
otherwise scheduled hours will be charged to your 8 hours of training time• If more than 8 hours is needed or more than 2 technical trainees need training, an
invoice for $349 for each 2 hour session will have to be paid in advance
Getting Ready for Technical Training• Download the Join.me desktop App from
http://www.InstantGMP.com/joinme
• Note: Make sure to use the computer that will be used during technical training. This computer should be used for Software and Configuration Training. • Note: Windows and Firefox are required (or Macs set to windows
mode)
Join.me Meeting - Remote Training• You can share mouse control with your instructor so he/she can
demonstrate functions of the software. Click the drop down on the right side of the menu and click “Share mouse control”.
Join.me Meeting - Remote Training• Your instructor may ask you to return the presenter role. If so, click
the drop down on the right side of the menu and click “Pass presenter role”.
Join.me Meeting - Remote Training• When the session is over, you can select the drop down and click “Exit
this meeting” either as a presenter (orange menu) or a participant (green menu).
Find articles and videos on cGMP compliance and quality in the Resource
Center at InstantGMP.com
TITLE: NUMBER: EFFECTIVE DATE:
InstantGMP Orientation TRN-1000.03-2.052 See Version History
VERSION EFFECTIVE DATE DESCRIPTION OF CHANGE00 New
01 Superseded by version 02
02 Updated to InstantGMP v2.052
03 Further updates to reflect new changes in v2.052
VERSION HISTORY
APPROVALS TITLE SIGNATURE/DATE
Reviewed By: Richard Soltero President
Reviewed By: Patrick Staunton Trainer
Approved By: Gretchen Rizor Quality Assurance
APPROVAL BLOCK