Thursday, September 10, 2009

GMP Audit

It is year end and the GMP auditors should now be busy meeting their surveillance schedule. GMP license holders should now be ready for such audit as these audits are on a surprise basis. We do not want you to be 'surprised' and faced with a compulsory shut down..!
I know most of the managers shiver thinking of the coming audit, but it is actually not that difficult to prepare for an audit. Why should you when you know that you have all in place...?

Important things to do is to check that your facility and equipment are in order with no severe defects. Ensure that documents and records are up to date and in order. Ensure that materials/products in warehouse and in production areas are well segregated, identified and protected. Hygience and cleanliness taken care of. Training of staff done as per training program. Self audit done, recorded and corrective actions taken. And many other routine things.....

A self audit will definitely helps in probing and uncovering any 'unturned stones'. This is best done by person not from that department, and better from outside the facility. Such person will have a look at your facility from a different angle and without bias. I am not promoting that you enagage us as an external auditors, but those who have done so did benefit from this service. Those in the facility are used to see 'non-compliance' happening right in front of their eyes and yet 'believing' it to be okay..... it's just like a normal thing.... they become 'immune' (if you know what I mean...)

However, external auditors can easily see such 'non-compliances'. Coupled with their experience at other facilities, such non-complaince can be easily spotted and proposed corrective actions can also be extended by these external auditors.

Whatever it is, always planned for a GMP audit and do not be taken by surprise. If you can have a well organized plan in case of fire, why not have one for a GMP audit....?

Good luck!

Sunday, September 6, 2009

Facility qualification of a new manufacturing plant

It really is a burden when asked to qualify a new plant that is almost completed...!

I have this unfortunate incidence whereby the owner requested for my service to qualify their plant, after the 'qualification' done by their respective supplier was found not to be in compliance to GMP.

Suppliers are not to be blamed. I blamed the M&E consultant for their ignorance in differentiating the 'qualification' needs between Good Engineering Practise (GEP) and GMP and highlighting it to the appointed contractor/supplier. The documentation needs and focus required by GMP is different from GEP. While GEP focus on the capability and safety of the facility, GMP focus more on the performance and ability to maintain product integrity and quality. Some (if not most) of the activities overlap. A well prepared qualification plan will cunningly make use of what's done under GEP to incorporate into qualification as required by GMP.

The recent ISPE conference in Singapore highlighted this matter in their pre-conference workshop and even provide examples on how this can be effectively done. To me, this is logic which should have been adopted much earlier if not for the 'narrow mindness' of some practitioner that GEP is a total separation from GMP.

Having said all that, the qualification of facility is still laborious and time consuming. The delay in initiating this effor, concurrent with the commission done by suppleir, will further aggravate the problem one have to face.

How I wish this qualification job was 'given' earlier to me as their GMP consultant, rather than entrusting it to the supplier....... but how can I reject...?