This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.

1. GOOD DOCUMENTATION PRACTICES
(GDP)

2. WHAT ARE GOOD DOCUMENTATION
The Definition of Good Documentation Practice (GDP)
Describes Standards By Which Documentation Is Created And
Maintained In The Pharmaceutical Industry.
WHY GDP IS SO IMPORTANT?
• Regulatory Requirement
• Customers requirement
• Documentation error can lead to severe consequence
– Product safety concerns
– Litigations (Law suits)
– Action by the regulators

3. GDP IS AN ADVERTISEMENT
Rs 35-40 Crores
So in the same way,
Document is our advertisement to show
How good we are.
How committed we are
How sincere we are

4. Different types of documents
• For organization & personnel
• For building & facilities
• For equipment's
• For production & process
control
• For handling of material
• For packing and labelling
control.
• For holding and distribution
• For laboratory control
• For records and reports
• For return goods

5. Documentation standards
– PERMANENT
– LEGIBLE
– ACCURATE
– PROMPT
– CLEAR / CONCISE
– CONSISTENT
– COMPLETE
– DIRECT
– TRUITHFUL
– CURRENT
– TRACEABLE / ATTRIBUTABLE

6. Documentation standard - PERMANENT
– Information can’t be changed, erased or washed off.
 Proper writing instrument
 No pencil
 No felt-tip pens
 Only ball point pens
 Permanent Ink.
 Black or Blue

7. Documentation standard - LEGIBLE
 Correct errors properly
 Draw a single line through the in-correct entry
 Make the correct entry adjacent to the incorrect entry
 In-correct entry must still be legible through the cross-out.
 Sign & date the correction
 Date of correction is the date , the correction was made,
not the date the error was made.
Information can be easily read

8. Documentation standard - LEGIBLE
 Do not
 Scribble out or black out with pen
 Write over
 White out
Information can be easily read

9. Documentation standard - LEGIBLE
Information can be easily read

10. Documentation standard - ACCURATE
Information recorded is accurate and calculations are correct
 Lot numbers, Serial numbers and product codes are double checked.
 Perform calculations at least twice
 Have the calculations reviewed and verified by second person.
 Present results in units specified.
 Check spelling in product names
 Compare hard copy vs Electronic copy.

11. Documentation standard - PROMPT
Information recorded in timely manner
Document tasks immediately after they are performed
 Never predate
 Never post date
 If you missed a step be truthful. Document it. And complete it at that time if
possible noting the actual date it was completed.

12. Documentation standard - CLEAR
Every one who reads the document
has the same understanding of what it means
 Looking at document five years from now , would some one understand what
I wrote.
 If you missed a step be truthful. Document it. And complete it at that time if
possible noting the actual date it was completed.
 Areas identified as not applicable shall be close with –N/A- with sign & date.

13. Documentation standard - CONSISTENT
Information such as dates, times, and abbreviations are recorded
to company standards. Practices should be consistent among all
employees
 Every form must be filled in the same way every time.
 Date format should be consistent
 Time format should be consistent
 Reporting decimals should be consistent
 Measuring units should be consistent

14. Documentation standard - CONSISTENT
Inconsistent practices
26/09/2017 9th Feb 2017 26/9/2017
99.9% 99.90% 99.904%
1000ppm 0.1% 1.0 mg/ml

15. Documentation standard - COMPLETE
All information included
 All required data filled correctly
 No blank spaces, Pages, or portion of the page.
 N/A can only be used when it is very clear that a portion of
document , form , record does not apply.
 All signatures available with dates.
 All supporting data attached.

16. Documentation standard - DIRECT
Information is recorded directly on to the proper form, Laboratory
note book or computer system.
 Original entry should made directly on to the GMP document.
 No scrap paper or Sticky notes.
 Do not write on palms, walls, Tables
Gloves and containers

17. Documentation standard - TRUITHFUL
All Information included in the document is, to the writers
knowledge and ability is factual.
 Your signature says information is true.
 Information must never be falsified. Because you are certifying
by signature.

18. Documentation standard - CURRENT
All documents are of current, All formats are of current
 Check current version every time before use
 Check approved version every time before use

19. Documentation standard - TRACEABLE
All documents should be traceable / Attributable
 Make it clear who logged the information
 What it was, and when and why it was documented.

20. GDP STEPS.
 Signature & date:
 All entries in a GMP document must be accompanied by the identity of
person and date that the entry was made.
 Recording time:
 Recording time in military format for each activity.
 Two digits two indicate Hours and Two digits to indicate minutes.
(08:15 14:05)
 Corrections:
 No hand written changes or Corrections allowed on printed text or an
approved GMP document.
 Corrections in handwritten entries should done as detailed above.

21. GDP STEPS.
 Performed by:
 Performance should be documented after completion of step and before
moving on to next step.
 Do not perform a step if procedure not available
 Recorded by:
 Recorded by is used if the operator performing the step and unable to
record for any specific reason, Data must then be recorded by another
person watching the operation with signature and date.
 Verified by
 Verification activity shall be done before moving on to next step.
 Verification can not be done for their own activities
 Verification shall be done by second person who witnessed the activity
and proficient in the task.
 Approved by
 Signature of qualified individual indicating that the documented
information is complete, accurate and acceptable.

22. GENERAL REQUIREMENTS OF GDP
 Clearly written documents / Using words that can every one can understand
 Using indelible ink
 Legible handwritten entries
 Performed by signatures
 Reviewing and approving
 Signed delegation of responsibility
 Page numbering
 Providing enough details to make sense of it in the future.
 Consistent wording to avoid confusion

23. KIRANREDDY MUNNANGI
https://www.kirandairy.com
https://www.slideshare.net/analyticalstudent/presentations