What is Document ?

Information and its support

Medium which could be paper form,
CD, computer film or microfilm
Eg.: records, specifications,
drawings, reports , standards,
specification, etc…

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 GOOD DOCUMENTATION PRACTICES

OBJECTIVE

➢ General awareness on Documentation

➢ 80 / 20% Criteria

➢Importance of Good Documentation

➢To implement Good Documentation

➢
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 Good documentation practice
Why Good Documentation ?

To define : specifications and procedures for all materials and

methods of manufacture and control

To ensure :
➢ that all personnel concerned with manufacturing know what to
do and when to do it.
➢ that authorized persons have all the information necessary to
decide whether or not to release a batch of a drug for sale.
➢ the existence of documented evidence, traceability, and to
provide records and an audit trail that will permit investigation.
➢ the availability of the data needed for validation, review, and
statistical analysis.

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 Good documentation practice (GDP)

➢ What might go wrong (Checklist from the observations)

➢ Day to Day jobs - Clear, Specific, legible and self

descriptive

➢ No Overwriting / No Whitening Fluid

➢ 80 / 20% criteria for Documentation

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 Highlights of GDP

• All entries in document shall be made online, legible,

free from ambiguity and in clear language

• Date – DD/MM/YY

• Time – 24 Hrs. format is advisable

• Use of scrap papers for recording data shall be

avoided

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 Highlights of GDP

• Post dated or back dated entries -- not permitted

• For wrong entry – single strike, put initial along
with date near the corrected entry, where
appropriate reason for correction shall be
recorded.
• No use of erasers
• Do not leave blank spaces in any document,
strikeout any blank space or page with cross line &
write in between lines NA (Not applicable)

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 Good documentation practice
Prepare a Check list from the observations and
follow.

Example :
When you write a “Cheque” as you take care:
- Is it crossed ?
- Is the date mentioned ?
- Name of person / organization is correct
- Amount written in figure and words matches?
- Signature is correct

➢ Similarly work out a checklist based on your day to

day review and observations.

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 Good documentation practice

As no overwriting is allowed in cheque, hence

you care your document….

Observations from customer :

“Sequential cuttings and overwriting

observed in Packing BMRs of
XYZ tablets”

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 Good documentation practice

• For want of 20% work, the 80% would stuck-

up
example :
➢ as your cheque will be hold without date by
Bank
➢ without COA /COC customer will hold the
batch for release

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 Good documentation practice

• Identify our weak areas :

• Working Documents produced from Master

Documents must not allow any error, should be
legible.
• Documents to be regularly reviewed and
updated. (weak areas?)
• Distribution to be controlled to prevent use of
obsolete documents. (weak areas?)

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 Good documentation practice

➢ Traceability
- Records are kept for
particular retention period as
per SOP.

- Document should be filed,

numbered, stored in
specified location for easy
traceability.

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 Good documentation practice

➢ Traceability
Example : After a long period when you approach
“Municipal Corporation” for copy of Birth/Marriage
certificate they trace it easily.

Why can’t your official Records/Logs?

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 Good documentation practice

you are owner

you leaves identity

you hold the credit

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 Good documentation practice

➢ Document should be self explanatory,

there should not be any confusion or
ambiguity.
Observation from customer:

“Product name is not same as mentioned on License as

per Licence G/29/XYZ Product name is XYZ Extended
release tablets but Batch record mention XYZ(base)
Extended release tablets ”

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 Good documentation practice
➢ Importance of Documentation

It is the written evidence

It has legal authenticity

It proves your work

➢ No document means work not done

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 Good documentation practice

It is the written evidence

PERSONAL
PROFESSIONAL
Answer paper/
WILLS / BMR / BPR / APQR
Agreements RECORDS/ LOGS

Personnel History Batch/Product History

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 Requirements of Documents

Good documentation practices (GDP) apply (not

limited to)

➢ Quality systems

➢ Regulatory agencies
(USFDA, MHRA, MCC, WHO, TGA, ANVISA, ISO)

➢ Internal customers, external customers

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 Document Number & Change
Document Numbering
Documentation is traditionally identified with a unique
number so that all pieces of a single document are
identified.

Document Changes
All documentation changes must be carefully documented,
reviewed, and approved.

Uncontrolled changes can have a substantial impact on a

company’s ability to demonstrate compliance to their
specific standards.

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 Correction and approval
•Corrections/Additions

• All corrections or additions shall be initial and dated.

• Only personnel who have already been approved to
author or make changes to documents can correct or
add to documents.
• Corrections shall be made by a single line.
Comments
Non-typographical error corrections or additions
indicating a change in data or acceptance status require
a comment.

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 How to make Corrections

➢ Place a single line through the incorrect entry

➢ Initial and date the adjacent to the cross-out
➢ Enter the correct data near the original entry
➢ The mistake must still be legible through the cross-
out.
➢ Date of the correction is the date the correction was
made, not the date the error was made.
➢Wherever appropriate the reason for correction shall
be recorded.
➢ Repeated cuttings not permitted

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 Good documentation practice

All documentation used to provide evidence that

standards are being followed must be signed and dated
by originator.

Documents shall be signed in permanent ink.

All documents requiring verification shall be signed by

the person verifying

Documents requiring approval shall be signed.

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 Good documentation practice

When writing in cGMP documents When writing in cGMP documents

do: do not
• Use only Green, indelible, ball-
point ink (for IPQA) & blue • Overwrite
(others ) • Use liquid correction fluid
• Make all entries legible (readable) • Backdate
• Initial and date all entries (unless a • Record data before the action or
signature is required) event has occurred
• Document each step before moving • Use ditto marks
to the next • Leave required data spaces blank
• NA, initial, and date spaces if it is • Approve, verify, or review your
not appropriate to fill them in. own performance
• Record numbers less than one with
a zero before the decimal point.

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 Important notes:

Deviations
If you deviate from a written procedure, you must
1. Notify your supervisor
2. Document the deviation using the appropriate
Quality Management System

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 Important notes:
Missing Data
If information is not entered at the time or completing the
step, the blank entry shall be marked by an asterisk or
similar notation. The use of each notation is limited to
one per page. Comments explaining the reason
information is missing, along with the proper information
(e.g date event actually occurred), shall be documented
on the same page of the record. The explanation shall
be initialed and dated at the time of recording.

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 Important notes:
Recreating and Rewriting Records:

Recreating or rewriting records should be avoided. It may be

necessary to do this. The supervisor and QA approvals are required
when recreating records. It is important to identify the recreated
document as “Rewrite” and to reference the sources of the
information. Records can be recreated only when:

The original record is illegible

An incorrect form or document was used

The record is reparable

The original was in a format that would not keep (thermal paper
strips)

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 Important notes:
Rounding of rules :

The following rules apply to rounding off :

In a series of calculations, carry the extra digits through to the final
result, then round off.

If the digit to be removed <5, the preceding digit stays the same. For
example, 1.84 rounds to 1.8.

If the digit to be removed >or = 5, the preceding digit is increased by 1.

for example, 1.85 rounds to 1.9.

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 Important notes:

Approved by: signature of a qualified individual (supervisor or

designee) indicating that the information documented is complete,
accurate, and acceptable.

Backdating: NOT ALLOWED

Batch Production Record: Collection of records associated with the

manufacture of a specific lot of product. Record containing all quality-
relevant planned and actual data on the production of a batch.

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 Important notes:
• Traceability - The ability to retrieve the history of the
product development, manufacturing, packing, etc.

• Performed By – Person executing the task and/or

recording the data.

• Verified by – Independent confirmation of an activity

or a result by either direct observation of a task or by
confirming calculations

• Reviewed By : someone with the technical ability to

assess the details.

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 Points to be remembered …….

• Back dating of entries is never permitted.

• All defined spaces that are not used must have an N/A placed
in that space

• It is acceptable to draw a diagonal line through a group of

spaces and record N/A once. (must be indicate the document
what is meaning of N/A). All short abbreviations must be
explained in the documents.

• Dates should be recorded following common practice of

Day/Month /Year as per policy of the company.

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 Points to be remembered…….

• Do not over write as 6 over 5

• To correct an entry, draw a single line through the
incorrect entry. The correct data is written directly
above or below the incorrect entry. The person
making the correction must initial, date, and
explain the correction.
• Partial corrections are not allowed due to potential
for ambiguity
• Some of the common abbreviation used for errors
EE = Entry Error, WW = Wrong Word Used, WO =
Write over, WN = Wrong Number, RE –recoding
error

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 Points to be remembered…….
• All documents must be filled out in indelible ink, blue or black
only. Inks that can bleed or run when wet should be
avoided, ball pen is preferred.
• Record all entries at the time the tasks are performed. do at
right time.
• Sign and date entries at the completion of the task do not
hurry.
• Documents should be promptly reviewed.
• Use only official formats.
• If it is discovered that an entry was omitted then perform
and record along with the date.

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 Signatures……….

• Always with date….

• Signature without date is considered

as manipulation

• Signature Log must be maintained

either as master or part of that
document.

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 DOCUMENTATION

• Attachment of documents---Ensure correct labels, COA

attached to the respective BMR ,BPR

• Reconciliation on time packing

Eg specification label: enter that time only

• Use Exact word referring to MFC/MPC

Eg . MCC specify it Avicel PH 102/101

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 DOCUMENTATION CONTROL
• All documents must be under control of QA.
• There should be SOP to prepare, approve, issue, hold and retrieve
documents.
• Issued Documents must have CONTROLLED stamp in red ink.
• Documents provided to any outsiders customer must have
UNCONTROLLED stamp.
• Ensure Retrieval of earlier version prior to issuance of new version.
• Each document must have document number.
• Superseded documents must have OBSOLETE stamp.
• Documentation room must be kept under lock and key with restricted
entry.
• Document room must be fire proof.

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 Thanks

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