GDP presentation for the manufacturing units which supplies for food & pharma industries

1. Training : Good Documentation Practice
FOR MANUFACTURING UNITS
WHO SUPPLIES FOR FOOD &
PHARMA INDUSTRIES.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry Contact - 9971779197

2. What is Good Documentation Practice?
The definition of Good Documentation Practice describes standards by
which Documentation is created and maintained in the
Pharmaceutical Industry.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

3. Why GDP is so important????
• Regulatory requirement
• Customer requirement
• Documentation error lead to severe consequences
- Product safety concern
- Litigations (Law suits)
- Action by Regulators
All companies having ISO Certificate maintains documents for manufacturing and related activities.
Documentation needs standard procedure for itself.
Good Documentation helps organizations easy retrieval of documents, track their data record and
audit clearance.
It's always beneficial to practice good documentation.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

4. Documentation Requirements
• Permanent
• Legible
• Accurate
• Prompt
• Clear/Concise
• Consistent
• Complete
• Direct
• Truthful
• Current
• Traceable/Attributable
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

5. Permanent
Information can't be changed, erased or wash off.
 Proper writing instrument
- No Pencils
- No ink pens
- Only ball point pens
 Permanent Ink
- Black or Blue
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

6. Legible
Information can be easily read.
Correct error properly
 Draw a single line through the incorrect entry
 Make the correct entry adjacent to the incorrect entry
 Sign & date the correction
 Date of correction is the date, the correction was made, not the date
the error was made.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

7. Legible
Information can be easily read
Do not
 Scribble out or black out with pen
 Write over
 Write out
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

8. Legible
Information can be easily read.
Problems to watch out for :
• Legibility of numbers and characters
0 and 6
U and V
S and 5
1 and 7
3 and 8
B and 8
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

9. Accurate
Information recorded is accurate and calculations are correct.
Lot numbers, serial no. and product codes are double checked
Perform calculations at least twice
Checked spelling in product names
Compared hard copy vs. electronic copy
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

10. Prompt
Information recorded in timely manner. Document tasks immediately
after they are performed
Never predate
Never postdate
If you missed a step 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
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

11. Clear/ concise
Everyone who reads the document has the same understanding of
what it means
Looking at document 2 years from now, would someone understand
what I wrote.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

12. Consistent
Information recorded like dates, times and abbreviations are recorded
to company standards. Practices should be consistent among all
employees.
 Every form should be filled in the same way every time.
 Dates & time format should be consistent
 Measuring units should be consistent
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

13. Complete
All information include
All data required 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 or record does not apply
All signatures available with date
All supporting data attached
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

14. Direct
Information is recorded directly on to the proper form, laboratory note
book or computer system
Origional entry should made on to the GMP document
No scrap paper or sticky notes
Do not write on palms, gloves, tables, wall or containers
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

15. Truithful
All information included in the document is, to the writer's knowledge
and ability is factual
Your signature says information is true
Information must never be falsified. Because you are certifying by
signature
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

16. Current
All documents are of current, all formats are current
Check current version every time before use
Check approved version every time before use
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

17. Traceable
All documents should be traceable
Make it clear who logged the information
What is was, and when and why it was documented
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

18. GDP steps
Signature & Date
All entries in the GMP document must be accompanied by the
identity of person and that date the entry was made.
Recording time
Two digits for hours and two digits for minutes
Corrections
No hand written changes or corrections are allowed to the printed
text or an approved GMP document
Corrections on hand written entries should be done as detailed
above
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

19. GDP steps
Performed By:
Recorded By:
Verified By:
Verification cannot be done of their own activities
Verification shall be done by other person who witnessed the
activity and proficient in that task
Approved BY:
Signature of qualified individual indicating that the information
documented is complete, accurate and acceptable.
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry

20. General Requirements of GDP
Clear written/ legible
Correct
Using indelible ink
Performed by signature
Reviewing and approving
Signed delegation of responsibility
Page numbering
Proving enough details to make sense of it in the future
Consistent wording to avoid confusion
4/6/2022
Prepared By : Tej Prakash Sharma
Manager – QA in Printing Industry