Documentation Practices

in GXPs
If It Isnt Documented,
It Didnt Happen.
Presented By:
Validation Plus, Inc.
14 Penwood Rd.
Livingston, NJ 07039
www.validationplusinc.com
(866) 760-2483

Course Objective
To increase the level of awareness on the

importance of good documentation

Applicable to all colleagues involved in the
production, review and/or supervision of
records and reports required by cGXPs
regulations (Subpart J - Records and
Reports)

Definitions
 Document - the record that describes how an

activity, event, or process was actually

performed (noun)
 Documentation- the preparation of a record
describing an activity, event, or process. It is
sometimes called record keeping (action)
 GXP Good X Practices where X can be: C
(Clinical), M (Manufacturing), or L
(Laboratory)
3

What Are GXP Documents?

 These are documents that are subjected to the

scrutiny of the FDA:

SOPs
Training Records
Equipment and Computer System
Validation Protocols and Records
Complaint Forms
Reference Standard Labels and Records
4

More GXP Documents

Manual Temperature and Monitoring Records

Equipment Log Books
Lab Reports and notebooks
Batch Records
Controlled Substance Transfer Forms and Log
Books
Stability Records

Why Is Documentation
Important?
 Identifies Roles, Responsibilities and

Requirements
 Creates an Audit Trail
 Serves As Evidence
 Details the Event
 Historical view of activities
 Remember. Documentation is what remains

after production, packaging, release, distribution

and sale of our products.
6

Why Is Documentation
Important (Contd)?
 Comply with regulations
 Provide a standard for

recording, reviewing and

approving data
 Keep track of activities
 Create legal documents
 Provide a historical record
 Inform
 Instruct (procedures, specifications)
7

Why Is Documentation
Important (Contd)?
 Reduce errors
 File and defend patents (for

research/development) successfully
 Prevent fraudulent behavior

Commonalities???

What Do These Two Objects Have In

Common?
Egyptian Pyramids Stradivarius Violin

work of art
expensive
object of high quality
no information
available on how it
was created

work of art
expensive
object of high quality
no information
available on how it was
created
10

Have Poor Documentation

Practices Caused You ...
 Problems in general?
 Wasted time?
 To redo a tedious and lengthy task?
 Wasted materials/money?
 Embarrassment?
 Frustration?

11

Practices To Internalize
 In our business we must:

Follow written procedures

Document practices
Document as it happens
Use validated systems
Make products that are safe, pure,
effective and of the highest quality

12

Repercussions
 Injury or death to consumer
 Company reputation - industry, regulatory

agencies
 Stockholders
 Reduced company revenue
 Your job

13

What YOUR SIGNATURE

Means
 your written approval
 you have reviewed document for accuracy and

completeness
 you have agreed to any conclusions
 you support the information
 you are taking responsibility
 your signature is legally binding in a court
of law
14

Examples of 483s Related to

Documentation Issues
 No record of this (GXP training) is in the

individual training files.

 One cross out without an explanation and two

transcription errors were observed in two

different validation reports.

15

Examples of 483s Related to

Documentation Issues
 There were no reports of investigations of lots

and batches failing specifications.

 There were no laboratory records for the

preparations of standardized volumetric

solutions.

16

Examples of 483s Related to

Documentation Issues
 Some production records were not accurate in

that, processing steps were not documented as

they were being performed - records for the
manufacturing of Product Y show step# 6 was
signed off, yet previous steps were not
completed.

17

Examples of 483s Related to

Documentation Issues
 Records of manufacturing deviations lacked

standardized information and/or format.

Records failed to include pertinent information
such as cause of the problems and conclusions.
 Line stoppages are not documented.

18

The FDA says:

In God we trust,
everyone else must write
it down!

19

Written Procedures
 Written procedures must define

Responsibilities for review and approval

Distribution
Authorization, Implementation and Change
Control
Changes that affect regulatory filing or
the validated status of a process, method
or equipment must be evaluated by the
Change Control Committee or alike
20

Documentation Practices
All GXP Documents must:
Be current and approved - never use deleted
or obsolete
Define scope and purpose
Be clearly stated and followed
Have revision or version number, if
appropriate
Have an issue/effective date, if appropriate
Be easily retrieved
21

Entering Information:
 Enter information using only permanent ink (no

pencils, flairs or water-soluble pens). In

manufacturing areas, use only pens without caps.
Use only black or blue ink.
 Record entry, signature and date immediately

following completion of step or tasks.

22

Entering Information (Contd):

 ONLY record information resulting from

INDIVIDUAL performance, verification or

observation of task(s) performed.
 Unused blanks or entries must be marked N/A
or Not Applicable, with a signature and date.
 Note: If full signature appears within the
document , then initials and a corresponding date
may be acceptable. Further reference to
signature/date will include initials/date (as
appropriate).
23

Approvals/Verifications:


An individual cannot perform and approve /

verify the same task(s).

ALLOWABLE:
One individual performs an action. A second
individual approves or verifies that action. The
result is completion or confirmation of the
specified action.
24

Correcting Entry Errors:

 Use a single line to cross out errors. Sign and date the

correction.
 A note(s) to explain a correction(s) are entered on the

same page as the corrected entry. Place the note as near to

the entry as possible. (Provide an explanation when the
reason may not be clear.)
 For correction of a calculation result, such as percent yield,

a comment such as Math error is the only explanation

required. This does not apply to the data entries on which
the calculation is based. Further explanation if a change is
required for data on which the calculations are based (i.e..25
weights, formulas, quantities, base units, etc.).

Use of Passwords & Electronic

Signatures:
 Electronic signatures and passwords represent the

individual who owns them.

 Passwords and electronic signatures are to be
executed solely by the individual who owns them.
 You are responsible for the confidentiality of
information entrusted to you.
 Persons utilizing electronic signatures must be
trained in the application.
 Sharing your personal password with others is
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prohibited

Use of Passwords & Electronic

Signatures (Contd):
 Sharing of passwords and entry of data using

another individuals log-on and/or password is

considered falsification and may result in
disciplinary action up to and including removal,
dismissal or termination.

27

Use of Passwords & Electronic

Signatures (Contd):
Question: Is sharing a password

considered falsification?

 Answer: Absolutely. This is a violation of GxPs

and company policies.

28

Use of Passwords & Electronic

Signatures (Contd):
Question: Are associates, consultants, and

contractors required to be trained on electronic

signatures and passwords?
 Answer: GxP training is required annually, for

all individuals who use, develop support or

maintain computer based systems or programs in
the performance of their job.
29

Falsification:
 Altered data

generating biased data or changing data that

is legitimately obtained
 Omitted data
not reporting data
 Manufactured data - Dry Lab
fabricating information or creating results
without performing the work
30

Falsification:
 Entering data when testing or other activities

have not been performed.

 Signing for work prior to that work being

performed, even if the task is about to be started.

 Signing for another persons work with your

name.
 Using other than todays date where

signature/initials and date are required (e.g. predated or post-dated)

31

Falsification:
 Changing original / non-retrievable data without

supporting documentation.
 Destroying original documentation or data.
 Documenting verification of data without

INDIVIDUAL observation.
 Entering or approving data / information using

someone elses log-on identification.

 Sharing of passwords and entry of data using another

individuals log-on and/or password is considered

falsification

32

Consequences of Falsification:
 Falsifying data or intent to conduct or

participate in a fraudulent activity will result in

DISCIPLINARY ACTION UP TO AND
INCLUDING REMOVAL, DISMISSAL or
TERMINATION.

33

Nine Characteristics of a Quality

GXP Record
 Permanent

 Consistent

 Legible

 Complete

 Accurate

 Direct

 Prompt

 Truthful

 Clear

34

BREAK ?????

35

Group Observations

36

Group Activities
 Break up into groups of 3-4 people
 Select a spokesperson
 Identify documentation errors on provided

examples
 Present them to
class

37

In Summary ...
 Documenting your work speaks to the

information, product, or service you

produced
 The documents you prepare should allow

someone in the future to reliably, clearly,

completely, and easily re-create an activity,
event, or process
38

In Summary ...
 Data must be clear (so everyone who reads it

arrives at the same understanding)

 Proper record keeping techniques need to be
applied in ALL documents
Apply the 9 characteristics of a well-made
document
 It takes less time and energy to produce a
quality document than to deal with the
frustration and potential regulatory issues that
result from inadequate documentation
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In Summary ...

If you dont do it right the first

time, when will you have the
time???

40

Remember...

The job is not done...

Till the paperwork is
complete!
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Learning Assessment

42

Multiple Choice - #1
 The main purpose of a record or document is to:
A)
B)
C)
D)

Meet regulatory requirements

Be able to recreate an event,
decision, or activity
Prevent lawsuits
Justify a patent application for a
new drug

43

Multiple Choice - #2
 The phrase, so everyone who reads the

information arrives at the same understanding of

it, is part of:
A)
B)
C)
D)

Legible
Accurate
Direct
Clear

44

Multiple Choice - #3
 The (US) standard way (s) to record time uses:
A)
B)
C)

A twelve hour clock

A twelve hour clock with AM or PM
designation
A twenty-four hour clock

45

Multiple Choice - #4
 The ink to be used when recording data is:
A)
B)
C)
D)

Blue or Black
Erasable
Water soluble
All of the above

46

Multiple Choice - #5
 An explanation for a recordkeeping error is:
A)
B)
C)
D)

Not needed
Needed only when the reason is not
obvious
Needed for all records
Needed only for GLP records

47

Multiple Choice - #6
 Properly prepared documents can:
A)
B)
C)
D)

Satisfy an inspectors questions

Help solve problems, deviations, or OOS
results
Reduce waste and improve quality
All of the above

48

Multiple Choice - #7
 Document entries must be made:
A)
B)
C)
D)

At the time when it is most

convenient
After the set of all related activities is
completed
Immediately after completion of a
step or process
Before the document is sent for
review by quality personnel
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Multiple Choice - #8
 You are handed a document by your manager

written 3 months ago. You inadvertently forgot

to sign and date it. What do you do now?
A)
B)
C)

Sign and date it using the original

date
Sign and date it using todays date
Review the document for accuracy,
sign and date it using todays
date, and write a brief explanation
as to what happened
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Multiple Choice - #9
 Which of these records are not GXP records?
A)
B)
C)
D)
E)

Equipment logbooks
Approval of Components
Packaging and Labeling
Financial reports
Production or Processing

51

Multiple Choice - #10

 You have recorded an entry erroneously. The

right entry is 53.12 grams. You have entered

51.32 grams.

How would you correct the wrongful

entry?

52

Multiple Choice - #11

 What is an acceptable standard to record the

date of July 25, 2003?

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