PharmScience Newsleter

I personnally do not know him but I find this guy, Lex Rudd, a very generous man. Wonder if he got any relationship with the Australlian PM...... ;-)

N'way, visit his site at http://www.pharmscience.com.au/ and subscribe to his newsletter at no cost. You will find that Lex share with us numerous helpful tips and info on GMP matters.

Not enough? Need to know more? Contact him for a GMP training.

Thanks Lex.

AJ.

MSc in Industrial Pharmacy

The Kulliyah of Pharmacy, Islamic International University of Malaysia (IIUM), plans to provide a master program in Industrial Pharmacy by year 2010. This will be a 15 months course work to equip students with the basic needs for practising in the pharmaceutical industry.

I find this program suitable for those who wish to venture into industrial pharmacy and those already in the industry but wish to equip themselves with the relevant knowledge as a career advancement. To be eligible, you must have at least first degree in science related field.

The program is meticulously designed for the pharma industry. Interestingly, IIUM even adds in one module on Management, which will expose students to the various stuff in management, finance, costing, conflict management, project management etc… You will also be able to take the elective courses on specific subject matters such as Logistics, Natural Medicinal Products, Vaccines, Biomaterial development & medical devices.

For manufacturers, it is good if you can sponsor your competent (and loyal) staff for this program. You will just have to spare him/her for 10-11 months with the balance practical training conducted in your own facility. Good eh?

My only wish is for this program to be industry-friendly, ie. Lectures should be scheduled on weekends to enable working students to participate. There should be assignments and self-studies in addition to attending lectures and practicals.

If you wish to know more, just call Dr Kausar at 09-5716681 (email: kausar.ahmad@gmail.com), or Mdm Juliana at 09-5716400 ext 268 (email: juliekz@msn.com). You can also contact me....!
There's only 10 places for the first year. I guess it will be first come first serve basis.

AJ.

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.