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Good Documentation Practices

Bujji Kanchi

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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.

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GMP Dancer

• I am a disco Dancer• I am a GMP Dancer

I am a GMP man

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I am a complan girl

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I am a GMP man

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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”

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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”.

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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

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Example over writing

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Over-striking

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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)

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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

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Version

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

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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”

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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)

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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

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Example-wrong practice

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Right Practice

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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.

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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

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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

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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 ”

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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

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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

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Questions