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Good Documentation Practices Bujji Kanchi 1. GDP is a part of GMP GDP is a part of GMP. Our aim is to follow to cGMP rules to produce quality and effective.

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Presentation on theme: "Good Documentation Practices Bujji Kanchi 1. GDP is a part of GMP GDP is a part of GMP. Our aim is to follow to cGMP rules to produce quality and effective."— Presentation transcript:

1 Good Documentation Practices Bujji Kanchi 1

2 GDP is a part of GMP GDP is a part of GMP. Our aim is to follow to cGMP rules to produce quality and effective drugs. Everybody should know the cGMP rules and regulations. Everybody should be a man of GMP, i.e He must be well trained in GMP and follow the same. 2

3 GMP Dancer I am a disco Dancer I am a GMP Dancer I am a GMP man 3

4 I am a complan girl 4

5 I am a GMP man 5

6 Documentation ? Documentation is most important when working in an regulated environment “ If something is not documented, FDA considers this as not being done at all ” OR “If it is not documented, it is a rumor” 6

7 Warning letter for documentation Warning letter to a manufacturer of API's in China – "There are no documented investigations of process deviations or out of specifications (OOS) laboratory results. She was informed that these investigations are conducted but not documented”. 7

8 Legible writing and Indelible Ink Legible menas Clear writing Indelible means Un-Erasable ink Blue color is preferred Over writing is not allowed: – Cut and write again (Such that previous entry is visible) – Any corrections should be counter signed 8

9 Example over writing 9

10 Over-striking 10

11 GMP Records Manufacturing Details – Operation parameters, start time, end time of operation should be written as soon as the actions are carried out. GMP records should be controlled documents (Numbering is must) 11

12 Registers and Records Each page of document should be accountable. Un used pages should be CUT. Records should be reviewed and approved Any deviation from the routine practice should be authorized 12

13 Version Versioning should be followed in all the approved documents if any amendments are to be done on same 13

14 A note about GMP records The GMP record should be such that “by looking at the record, one should be able to reconstruct the sequence of activities which were carried out” 14

15 Equipment/Instrument Log books All equipment log books should be bound (Please note loose sheets should not be used. Implement bound log books immediately if not followed) 15

16 Records Each page of bound book should be numbered No line should be left blank in the log books. Un used pages should be cut After completion of the log book, same should be retuned for archival Every record must be ready for retrieval 16

17 Example-wrong practice 17

18 Right Practice 18

19 Updates the entries in the log book Update them on a Usage/daily basis Note : If any entry is missed, the same should be intimated to QA. The entry can be made on the next day with a note/remark and approved by QA. Please Note this will be on exceptional case. 19

20 Preserving the documents Bound records to be preserved from being “dog-eared” Wherever possible use water sponge or note grips to flip papers Pages left in between by mistake should be cut and signed 20

21 Preserving the documents Documents in regular use should be preserved from solvents, powder, chemical spillage on them Pages of log book needs careful, preservation by operators Pages likely to be detached from the main book should be fixed whenever noticed DON’T 21

22 Reporting of Date and Time Best practice is to write all the activities in 24 hour time format As and when the date is changed please write the date in the left hand side corner of the page (the changed date) All the instrument date format should be set to “DD / MM / YYYY ” 22

23 Review Review of results/ activities concurrently Reviewer should to put sign and date Any corrections should be logical Corrections should be counter signed with date by the reviewer 23

24 Doubt/ Changes in document In case of any documentation doubts immediately consult Executive – QA Minor changes in any document procedure would require approval and version control Change control SOP to be followed at all times 24

25 Questions 25


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