Importance of good documentation in GMP

Everybody knows that documentation is critical in GMP, but not Anybody can assure of a good structured system of documentation to supplement the good process and GMP control in the facility.
Somebody need to be in the reign to control and monitor GMP documents and not leave it to Anybody to do it, cause it will end up with Nobody doing anything on documentation.....
[just relating the story of the 4 persons; Nobody, SOmebody, Anybody and Everybody...]

GMP licensed facility are regualrly audited by the government GMP auditors on a periodic basis. These audits vary from one day to 3 days, and by one auditors to as many of 9 auditors! Auditors do not waste their time to scrutinize all the operations steps and process controls being carried out by operational staff. However, they spend more time on scrutinizing documents; on schedules, SOPs, work instructions, records, log books, test data, calibration certificates, and any form of document that will help them evaluate and access the level of compliance.

We used to joke that GMP is "Generate More Papers", and this seems true in reality. We have tons of documents to handle. As operation get more complex, we have more documents to cater to... However, there should be no excuse if you are not able to retrieve the particular records required by auditors during their audit. Anything more than 30 minutes to retrieve a particular record will be deemed that you have underlying 'problems' in your document control procedures; and this leads to the procedure being scrutinized.

So, my piece of advice, do not ignore and take your current document system for granted. Look into the details and ensure that you have a well structured and organized document system that is being followed by everyone in the organization.! Get help if you are sure where you stand.

Good luck.
AJ.

GMP Documentation Training, 5 to 6 Oct 09

This training was organized by Malaysian Biotechnology Corporation for Bio-Nexus status companies. And it was free of charge! Training done at Istana Hotel - good environment and good food...... En Lukmani from the GMP Compliance div. of NPCB came to give the first paper and the rest by A1 Consultancy.

We expected only 20 participants but ended up with more than 30!

Many critical documentation matters were discussed including validation. The wide diversification of participants; from those very fresh in GMP to those already seasoned, made it difficult to strike a balance on the level of knowledge to impart.

Anyway, it was a beneficial training session to all participants. Thanks to Msian BioTech Corp for the great effort!

AJ.

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!
AJ.

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...?

AJ.

Kotra Pharma's new facility

I was passing by Cheng Industrial Estate Melaka, and was amazed to see the progress in Kotra Pharma new facility. It is such a huge 'state-of the art' facility, and multi storey. How I wish the management may open up their facility for us to visit before it is commissioned......


This is Kotra Pharma's existing plant. Already a big one.....
Now you only see 50% of the building

.
This is their new plant. Still under construction. This is only the front view... The facility looks 4 times bigger from side.










Wish all the best to staff and management of Kotra Pharma Sdn Bhd.

AJ.

Qualification required for secondary packager

You may not realize this but the activity of filing is still regarded as a critical processing area where the products are exposed and open to risk of cross-contamination. Secondary packager may not be involved in the manufacture of products, however, they are still required to validate their HVAC system for the filling process.
Water used for final rinsing of contact parts must also be of Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
=(

AJ.

Cosmetic notification wih DCA

To those who have submitted notification but not remit your payment...... beware as the authority has declared that any payment not remitted before 15 August 2009 will face the wrath of DCA.
You will not be punished, but your submission will be withdrawn or rejected.
No big deal...? If you have a long list of ingredients in your formula, you will know the pains of entering these data.
Well... most of the paymasters are not the same person entering these data into Quest2. So, why bother....? At least, some people will be kept occupied re-entering the notification data.

AJ.