Training programme

GMP Documentation and Control

ACME LABORATORIES
GMP TRAINING
 Documentation is a Cornerstone of GMP

Provides Instruction
Collects Variable information
Provides full traceable History
Controls development and
change

Priority for

IMB,FDA and
Customers

ACME LABORATORIES
GMP TRAINING
 Documentation and EU guide

Good documentation constitutes an

essential part of the quality assurance
system. Clearly written
documentation prevents errors from
spoken communication and permits
tracing of batch history.
Specifications, Manufacturing
Formulae and instructions,
procedures, and records must be free
from errors and available in writing.
The legibility of documents is of
paramount importance.

ACME LABORATORIES
GMP TRAINING
 FDA and QC Documentation

No specific entries in the CFRs

Lots of non specific entries in Sub-part I Laboratory
Controls and sub-part J records and reports
211.194 Laboratory records

ACME LABORATORIES
GMP TRAINING
 Basic Documentation control

Documentation is an essential part of

QA and relates to all aspects of GMP

If its not documented, its a rumour

If its not signed, its graffiti

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GMP TRAINING
 Life Cycle approach

Origination
Approval routing
Change Control
Copy control
Issue
Retrieval
Completion Review
Archiving, Retrieval
Disposal

ACME LABORATORIES
GMP TRAINING
So what is documentation for?

It ensures that there are specifications

for all materials and methods of
testing and control

It ensures all personnel know what to

do and when to do it

It ensures that authorised persons

have all information necessary for
release

It provides an audit trail

ACME LABORATORIES
GMP TRAINING
 How should I write my documents?

Give simple
instructions:
Do this ,do that
Dont use complex
nomenclature and
verbiage, keep it
simple and brief
Use plain English

ACME LABORATORIES
GMP TRAINING
 Basic control of Documents

Documents should be:

designed prepared reviewed and distributed

with care !

ACME LABORATORIES
GMP TRAINING
 Why are documents so important?

Communication-everyone
must understand what they
have to do
Cost - the business must know
how much things cost
Audit trail - We must be able
to find out what happened

ACME LABORATORIES
GMP TRAINING
 Documentation Systems

Worksheets
Notebooks
Log Books
QC contains more records
than production
Production batch is probably
supported by 10 or more QC
batch documents
Master docs and working
copies

ACME LABORATORIES
GMP TRAINING
 What type of documents are there?

Analytical methods
Raw material test records
Specifications
Finished Product test
records
Standard operating
procedures (SOPs)
Validation protocols and
reports
etc etc etc..

ACME LABORATORIES
GMP TRAINING
 Basic documentation Control

Compliance is critical Honesty is vital

Deviations must be recorded Integrity must be absolute
Accuracy is essential Legibility is indispensable
Importance of double
checking
How to correct errors
Time and date recording

ACME LABORATORIES
GMP TRAINING
 Basic control of Documents

What happens before a document can be used

They must be approved signed and dated by
appropriate authorised persons or whatever system
your company utilises
Never change a document without authorisation

ACME LABORATORIES
GMP TRAINING
 Basic Documentation Control

Dont write things on unapproved documents or a piece of paper (or other material!) to copy
from later.

Always record your activities.

Always record your activities when you do them

Never sign for anything you have not done yourself

Remember there are two 6 o'clocks in a day! Always record am or pm (or use 24hr
clock)

Dont just write N/A (unless you are instructed to). Always explain why

Never use ditto marks

If you make a mistake, always correct correctly!

ACME LABORATORIES
GMP TRAINING
How should I use my documents?

Read them!

Make sure you understand what

you have to do!

Ask if you are not sure

ACME LABORATORIES
GMP TRAINING
 What if I make a mistake?

274.465 274.465
274.456

274.465
274.456 274.465
56

274.465
274.645 RAW 29/05/08 trans. err
ACME LABORATORIES
GMP TRAINING
 EU Guide Data entries and alterations

4.7 Any alteration made to

the entry on a document
should be signed and dated;
the alteration should permit
the reading of the original
information. Where
appropriate, the reason for
the alteration should be
recorded.

ACME LABORATORIES
GMP TRAINING
Alterations to Data

125.986 129.586
RAW 29/05/08 Trans error

ACME LABORATORIES
GMP TRAINING
 And never ever forget:

The jobs not finished until the

paperwork is done!
ACME LABORATORIES
GMP TRAINING
 Documentation

Notebooks versus
Worksheets
Either system can be used
Each system has ++++ and -
----
Some companies use both
depending upon the lab
environment
Whatever system is used,
requires control

ACME LABORATORIES
GMP TRAINING
 Worksheets
Used to record primary data from QC activities
Forms are part of the SOP or Specification
If written correctly can achieve very good
compliance in respect of data capture
GMP by design not memory
Must control layout and format correctly
Very good for batch file storage

ACME LABORATORIES
GMP TRAINING
 Worksheet: data recording

Simple test :Loss on drying

What info should we record

1 9
2 10
3 11
4 12
5 13
6 14
7 15
8 16
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GMP TRAINING
Worksheet: LOD

ACME LABORATORIES
GMP TRAINING
Worksheets pH

ACME LABORATORIES
GMP TRAINING
 Documentation: Worksheets

How are they issued

Within QC or other dept
Stockpile of sheets
Watermarked paper
Reconciliation?
Re-issue of sheets
Controlled by SOP
Dont throw away damaged sheets

ACME LABORATORIES
GMP TRAINING
 Notebooks

Used to record primary data from QC activities

Type varies from company to company indeed from
dept to dept in same company
Handwriting and legibility
More suited to Development labs due to nature of
work (experimental not confirmational like QC)

ACME LABORATORIES
GMP TRAINING
 Documentation: Notebooks

How issued and to whom

How used (sop?)
How are books numbered?
Are they indexed and or
paginated
Ownership (leavers)
Shelf life and where kept
How is location of data
documented

ACME LABORATORIES
GMP TRAINING
 Documentation: Notebooks

How is the primary information recorded

Transcription errors
Who checks and how often
How is data referenced
Where are books kept

ACME LABORATORIES
GMP TRAINING
FDA and Notebook Control

Above comments in Warning Letter from July 2005

ACME LABORATORIES
GMP TRAINING
 Documentation: Notebooks

Inserts, printouts and attachments

Frequency of checking and how
checked
Development labs often weekly
even fortnightly
QC should be checked each
test/batch
Multiple notebooks for one batch
of product
Not in product batch file
Legibility

ACME LABORATORIES
GMP TRAINING
 EU GMP guide and Log Books

4.28 Log books should be kept for major or critical

equipment recording, as appropriate, any validations,
calibrations, maintenance, cleaning or repair
operations, including the dates and identity of people
who carried these operations out.
4.29 Log books should also record in chronological
order the use of major or critical equipment and the
areas where the products have been processed.

ACME LABORATORIES
GMP TRAINING
 Log Books

Types as variable as
companies
Simple diaries as line logs to
fully indexed paginated
bespoke books.
Used to record basic info
Often overlooked and never
checked except by auditors

ACME LABORATORIES
GMP TRAINING
 Log Books

Should have sop reference

on log book
When collecting data e.g.
temperature include limits
on log book
Multiple equipment log
books or room log books?

ACME LABORATORIES
GMP TRAINING
 Log Books

How issued and to whom

How used (sop?)
How are books numbered?
Are they indexed and or paginated
Ownership: reference equipment
disposal or completion of book
Archive of completed books
where kept
How is location of data
documented

ACME LABORATORIES
GMP TRAINING
 Log Books

The log book should support

the GMP activities
Satisfactorily completed log
books equate to control and
supervision?
No significant problems
with data entry leads to a
degree of comfort by the
auditor

ACME LABORATORIES
GMP TRAINING
 Log Books

Risk if not completed

correctly depends on what
data is being collected
Area cleaning!!! Missing
signature equates to X
contamination?
Temperature logging
missing info equates to OOS
and rejections?

ACME LABORATORIES
GMP TRAINING
 Training programme

Any
Questions?

ACME LABORATORIES
GMP TRAINING