Revision Frequency of Documents (in ISO 9001, cGMP, GMP or others)?

[meo786]

Dear Sir,

i want to know what is the frequency (maximum & miminium) revision of the documents (in ISO, cGMP, GMP or any other standard).

Thanks in advance.

[antoine.dias]

According to ISO 9001 the documents have to be reviewed (4.2.3.b) no specific frequency is mandatory.

I come in a lot of companies and I see frequencies used between 1 and 3 years.
Don't know if any of the other requirements are more specific but I don't think so.
Be careful as even some customers have requirements in that direction.

Hope this gives you an idea.

Best regards,

Antoine

[SteelMaiden]

Hopefully, it is a language thing, but you ask about frequency of revision....you only have to revise a document when there is something that has changed in your process.

But, I think, as Antoine did, that you are really meaning reviewed for suitability? In that case, it depends upon you and your company. The standard says periodically. In nearly all cases, periodically is understood to mean at a minimum of once in each registration audit cycle (typically 3 years). But, that is minimum. How often do things change in your business? Pick something that works for you.

[AndyN]

In ISO/IEC 17025 - I believe there is a requirement for an annual review of lab procedures etc (if I recall correctly). As previously stated, most standards don't require a regularly scheduled (frequency) of review of documentation.

Can we ask why you are looking for this information?

[meo786]

Dear Sir,

first of all thank you very much for reply.

Dear Sir,

Actually our format for the procedure / format have the information like

Issue Date
Next Review Date

My company is the Pharmaceutical that is manufacturing antibiotic in bulk, so our customer are not only the national but international, so they required this.

Initially we defined it two year but we want to extended to 5 years.

In Reply to Parent Post by AndyN

In ISO/IEC 17025 - I believe there is a requirement for an annual review of lab procedures etc (if I recall correctly). As previously stated, most standards don't require a regularly scheduled (frequency) of review of documentation.

Can we ask why you are looking for this information?

[Raffy]

In our end, we define it every two years, we are an ISO/TS16949 Certified company.
Raffy

[meo786]

Dear Sir,

Thank you very much for reply, can u give me the reference for two year's revision

In Reply to Parent Post by Raffy

In our end, we define it every two years, we are an ISO/TS16949 Certified company.
Raffy

[Ajit Basrur]

Agree with Antoine - in most Pharmaceutical companies, the usual trend is 1 - 3 years and defined in your procedures.

But in course of this, if you feel there is a need to change the SOP (leaving the typo errors), it should be done and wait for the revision date.