Hello group,
I am new to this forum but have LOTSA questions!!!
I am a new archivist in a research facility and our archives need some updating. etc. I want to hear how you guys handle lab notebooks. What is the most efficient yet safest way to store them If one has to keep them about 20 years (IF!)??
Thanks.
Raul
As per the GMP’s you have to (must) keep lab books for 7 years past the expiry date of the product that last expires.
Scenario: a lab book that was first used in 1995 (product expired in 1998) and was filled up in 2005 (product exipres 2008)… you will have to keep that log book until 2015, just to be sure that the data is not called upon by an inspector.
All documentation related with product must be arhived untill product expirie date + one year. Because expiration date maximum is 6 year you have to keep it 6+1=7year.
Since in note books you have date about more product (different expiration date), the date closing book is the easyest for orientation.
On that date you add 7 years and definitly you will comply GMP requirements.
Keep research books until patent expires in the event there is a patent dispute. As far as the records retention time, 7 years (1 year after product expiry date)
Dear Mary
all the records relevent to product like Batch manufacturing record and Analytical raw data noted in lab analyst log book is kept upto the 1 year after product expiry. somewhere it is kept after 2 two years of product expiry, so this logic of 7 years that u have fixed or u r also witing after one year + expiry is quite confusing. we need to b clear here that after product is expired wether it is 2 yaer or 6 year we have to keep record after 1 or 2 (on safe side) year of product expiry date. Drug registration files are kept long lasting unless n untill product is withdrawn from the market.
Regards,
Shahid Ali
Addis Pharmaceutical Factory SC, Ethiopia
Dear Shahid
It is better to kept all master documents ( Ex: BMR,BPR,Specifications,test procedurs) for 7 years, asper MHRA guidelines,also MHRA stress on retrival of obsolute documents from respective dept. and destruction of the same and also approval should be taken from QA head.
pvalidation
Dear Shahid
It is better to kept all master documents ( Ex: BMR,BPR,Specifications,test procedurs) for 7 years, asper MHRA guidelines,also MHRA stress on retrival of obsolute documents from respective dept. and destruction of the same and also approval should be taken from QA head.
pvalidation
[quote=pvalidation]Dear Shahid
It is better to kept all master documents ( Ex: BMR,BPR,Specifications,test procedurs) for 7 years, asper MHRA guidelines,also MHRA stress on retrival of obsolute documents from respective dept. and destruction of the same and also approval should be taken from QA head.
pvalidation[/quote]
Dear Pval
First thing is that MHRA has no guideline on GDP, yes it has one guideline on “Good Laboratory Practice Guidance on Archiving” that is about The archiving of study materials and test facility records, its storage and retention. I have read the guideline thoroughly but i didnt find a 7 years fixed retention period for above stated documents. In fact it uses the term “specified retention period”, Anyways if u could give us a valid reference and a phrase from that guideline, it would be a great help for all, in updating the system.
I m agreed with Mr.Shahid commnets,
Dear Raul,
IF 20 years…
Go for microfilming or digital photo copying of your document.
Make minimum 2 or 3 copies. Keep them separate. This is efficient and
the safest way.
where i can get MHRA guidlines