Module 2 - documentation ppt. S 23.02.2012.ppt

8/10/2019 Module 2 - documentation ppt. S 23.02.2012.ppt

1/24

1

DOCUMENTATION


2/24

2

DOCUMENTATION Nine characteristics of Quality GMP RecordPermanent

Legible AccuratePrompt ( Written at the time activity was done)Clear ( so anyone can read and understand what ismeant )


3/24

3

DOCUMENTATION ConsistentComplete

DirectTruthful


4/24

4

DOCUMENTATION - Objectives 1)

To review general requirements for documents

2) To review specific requirements for each document


5/24

5

DOCUMENTATION -

General PrinciplesDocumentation is an essential part of QA and relatesto all aspects of GMP

Purpose of documentation to ensure that there are specifications for all materials andmethods of manufacture and control

ensure all personnel know what to do and when to do it

ensure that authorized persons have all informationnecessary for release

provide audit trail


6/24

6

DOCUMENTATION What is being made?

Most of us when

attempting a task needsome sort of documentation


7/247

DOCUMENTATIONInstruction is wrong? Or instruction is followed wrong?!!


8/248

DOCUMENTATION

Why are documents so important? Communication Audit trail Investigation Proof of Activity


9/249

DOCUMENTATION - Objectives

Some may think that GMP stands for Great Mounds of Paper! Theres some truth to that. The paperwork we produce is of equal importance to theproducts we produce

Product = Paperwork


10/2410

DOCUMENTATION -General Principle

Documents should be Designed , prepared, reviewed , distributed with care

Design of documentation

Instructions in the imperative, Short sentences, Not long sentences Approval of documentation

Approved, signed and dated by appropriate authorized persons No document should be changed without authorization

Distribution of documentationElectronically or photographically recorded dataReview - system for regular revisionCompletion - during the process


11/2411

Purposes of GMP Documentation There are three main purposes forGMP documentation:

To meet legal requirements includingall GMP expectations

To meet our business requirementsTo form the basis of good scientificdecision making


12/2412

Purposes of GMP Documentation To understand what needs to be done (the

process) To understand how to do it (the method) To understand why it needs to be done (the

context) To understand who must do it (the responsibility) To understand when to do it (frequency, close out) . At the end : to ensure that there is an adequate

record of who did what, when, how and why !


13/24

13

DOCUMENTATION TypesLabels, specifications and master formulae

Batch processing and batch packaging records

Standard operating proceduresStock control and distribution records Water quality manual Analytical recordsOther types (log books, registers, maintenancerecords, schedules training, audits, complaints,investigation records)


14/24

14

DOCUMENTATION - Models Photographs and Plans can be documents and part ofSOP provided they are properly authorised and controlled


15/24

15

DOCUMENTATION - Models Flow charts provide substantial information at a glance


16/24

16

DOCUMENTATION - Labels What must be labelled? What must be on the label? Who has responsibility for labelling?


17/24

17

DOCUMENTATION - Master Formulae

Manufacturing and packing instructions to have the details of Name of product with product reference code and batch size Full list of materials including quantities; unique reference

code Expected final yield with acceptable limits (+intermediate yields)

Processing location and principle equipment Equipment preparation methodology Stepwise processing instructions with time limits Details of in-process controls with instructions for sampling

and acceptance limits Storage requirements and special precautions.


18/24


19/24

19

DOCUMENTATION- atch

Manufacturing RecordsDetails of packaging operation, including equipmentand line usedReturns to storeSpecimen of printed packaging materials, with batchcodingComments on deviations from the process and actionstaken

Reconciliation of packaging materials, includingreturns and destruction Area clearance checkProduct variablesRecord of activities and check signatures


20/24

20

DOCUMENTATION - Records What are records ?

What should be recorded?

Where should records be stored?

Why are the records important


21/24

21

DOCUMENTATION - Recording A clear online documentation is the key to many queries

To know exactly what we did, and when we did it.To correct mistakes if they happen.

To PREVENT mistakes from happening in the future
http://www.dreamstime.com/stock-photo-vintage-key-image1959370


22/24

22

DOCUMENTATION - Recording Recording Tips1.Write on any official document using a non-water soluble pen

(No pencils)2.Clearly record the data. 24 or 29 ?

Take your time and write clearly. 3. There is a proper method for making corrections

No erasures ,No correction fluid , No Post -it notes -to be dated and signed

4. Enter enough details so the document can be understood in thefuture.

5. Store completed Documents securely


23/24

23

Purposes of GMP Documentation

PROCEDURES SHOULD BE WRITTEN AND FOLLOWED

It is a concern if an SOP has not been in place

But it is a violation of the GMP requirements, if the SOP is present, but not followed.


24/24

24

DOCUMENTATION -

slogan

Not recorded is not doneNot done is not followed

Not followed is not acceptableNot acceptable is not allowedNot allowed is non existence!

Non existence is definitely not ourbusiness motto!!