Simplified Presentation on Good Documentation Practice (GDP).

1. Prepared ByPrepared By­ Shoab Malek­ Shoab Malek
Certified Quality Auditor & Pharma ConsultantCertified Quality Auditor & Pharma Consultant
shoab.malek@gmail.comshoab.malek@gmail.com +91 9638069084+91 9638069084

2.  The purpose of good documentation practices is to
provide basic guideline and standard ways for
correction of errors in documentation

3.  This good documentation practices applies to all the
documents prepared at (Company Name).

4.  It is the responsibility of all persons who are
involved in preparation, completion or reviewing of
documents to implement these practices.

5.  Check double check the entries to sort the mistakes in
documents.
 Be sure that document is correct and complete prior to
forwarding for next process.
 Look at the documentation that essential part of whole job and
not as an inconvenience.
 Write each word clearly and legibly.
 Know the procedure for cross-out the wrong word or sentence.
 Never use White Ink or Scraper.
 Proper completion of documentation is important to ensure the
traceability and accountability.
 Every process must be documented.
 Never trust your memory and record all necessary information
immediately.
 The work is not completed until it is documented.
 Don’t use pencil on document.
 Back dating on any document is not allowed.

6.  Use a single line to cross out the mistake.
 Never use White Ink or Scraper.
 Never erase or remove wrong written information.
 Ensure that original entry is still legible.
 Make the correction with initial and dates.
 Write a short explanation, if required.
 Initial must be done on cutting with date.
 If any entry is made wrong in a document for example if batch #
of any product is written like 389 instead of 398 then the wrong
batch # should be cut as a whole and not partly. It should be
initialed and dated.
 38­9 → Wrong practice
 389 → Correct practice
 In case if an option is given in production BMR such as a.m/p.m,
then one option can be omit/cut without any sign.
 Spellings of words in documents are critical especially in case of
ingredients, equipments names and technical data. Such
information if spelled wrong should be corrected, initialed and
dated.

7.  Only the person responsible for the error should be
notified to correct the error. In case the person is
absent or has left the company only then supervisor/
manager of the person responsible for the error
should be contacted to do the correction.

8.  Whenever comments or remarks column is given in
the document, comments should be entered with
initial and date.

9.  No column space, box should be left blank in
document. It should be marked as dash (­).

10.  Missing information in a document should be filled
only by a person responsible for the job. It should not
be done a second person. If the person responsible is
absent or has left the company the supervisor/
Manager of person should fill relevant information
along with initial and date.

11.  Signatures are required such as BMR, SOP, change
control forms, protocols and procedures. In case of
working documents Initials can be done such as
batch record sheets, in process sheets, QC reports etc.

12.  Black ink color should be used by production/ QC/
QA for documentation. It should be used for all
entries and signatures on original documents such as
master BMR, SOP, Change control form, and
protocols to distinguish the original signatures.

13.  If a document such as a log guide or a SOP is under
review, corrections related to grammar can be done
at this stage. If grammar correction is required in an
approved document, it should be done whenever
next revision is due.

14.  All the dates in a document should be entered in a
consistent manner such as DD/MM/YY or
DD/MM/YYYY.
(29/10/16 or 29/10/2016).

15.  Final approval in all QC reports such as test reports,
stability reports, validation and calibration reports
should be dated.

16.  All the entries must be completed at the time the task
is completed. Don’t depend on memory or memory
of others.

17.  It is the responsibility of everyone who complete or
review a document to ensure its accuracy.
 Documentation error that have not been properly
corrected should be reported to the immediate
supervisor.

18. Thank You