ISPE - International Society for Pharmaceutical Engineering

If you are a GMP practitioner, you must join ISPE as a member. The benefits are numerous; amongst which are access to good training notes, info on training conducted all over the world, updates and even forums.

It is best that you visit the website www.ispe.org.my to know more. Enrol as member if you are convinced.!

GMP Training at UNZA, Subang Jaya.

Unza manufacture only cosmetic products, but their commitment to train their staff on GMP matters are something we should salute.

Today, we conducted 2 sessions of training on 2 different groups of 23 line leaders and operators. Tomorrow, there will be another 2 sessions on different subject matters, on another 2 groups.

Unza started this GMP training few years back, starting with the high level managers, to executive, then supervisors, and now down to their line leaders and operators. It is easy for Unza as most of their personnel are long serving and stay with the company. Turnover of personnel is very minimal...!
Unza's consistent effort is much reflected in the satisfactory condition of their facility and level of GMP compliance.

How I wish all manufacturers of pharmaceutical products can follow the path done by Unza in ensuring compliance to GMP within their facility.

AJ.

GMP Consultation work

Doing GMP consultation work can be very demanding and risky. While it does gives me the satisfaction when job is done and completed, the problems in between really can get on your nerves.
I have one job in the East Coast where the facility is almost ready..... If you are running for one km, I can say that this is the last 50m. But the facility owner run out of cash to push the project to its end. So, how we complete what we intended to do...?
To add salt to the situation, payment on consultation job was not paid for the job done. So, how can we proceed to the next stage?
Consultation work is not charity work. We need resources to pay for our overhead and for travelling.
So, the project now stalls...... all because of money. Client suffers, and consultation get a damaged reputation for job not completed, although not the fault of the consultant...!

Lesson leart; be ensure that the facility owner is financial ready before starting a project on a GMP manufacturing facility.

AJ.

Burned out...

In pharma plant, everyone get tired with the routine work. Too tired and too pre-occupied with work that no one has the time to re-look at current systems, review documents, monitor test results and analyse trendings....

How to improve...?

Forgotten case of stability studies

Doing work as a consultant brings me to see many facilities. I am amazed with the high numbers of licensed manufacturers being unaware of the needs to conduct stability studies for all registered products; be it theirs or products owned by others (contract givers).
It is prudent to note that the responsibility is on the product licensed holder to conduct a Real Time stability study as per the ASEAN Stability study guideline, once the product is registered and manufactured. Your product may be withdrawn if this is not done.

To conduct stability study, you just need to take 3 different batches of each product. It further amazed me when manufacturers took the pain to keep samples from EVERY batches produced for the stability study..! No wonder some people are so tied down with work that they are unable to see what exactly are required for the stability study.

The storage condition is another common blunder where you can see stability samples kept in a conditoned different from the recommended storage condition as stated on label. Such act will simply invalidate all the effort done in your stability studies.

My suggestion...... please find some time to read up the guideline and plan for your stability study program. The time spent is worth the effort taken.

AJ.

To Pilot Plant IIUM

Bravo! Finally we see some light to the end of the tunnel for this Pilot Plant. It is usual to have glitches here and there, but as long as the management understand and cooperates (in terms of financial assistance), I am sure all problems can be solved....

The waiting still prevails. We still have some minor loose ends with the utilities qualification. Few more equipments are pending qualification.
But we do have the human resources to get the plant busy.... So girls and boys, carry on with your routine operation run. Get familar with all the utilities operation and controls. Run the machines and be familiarize with the settings. Also finally..... clean, clean, and clean.....! Keep the plant sparkling clean and shine...!

Since GMP relys on documentation and records, do get all the SOPs ready for use on the shop floor. Whatever done, make sure it is recorded.

Let's make this pilot plant ready at any time for the pre-licensing audit.

AJ.

GMP dilema

GMP guidance provides ample guides in ensuring the safety and quality of drugs manufactured. As the name implies, it serves only as a guide, not as a rule that you MUST follow.
This leaves us a lot of freedom to implement methods most suitable to our own needs, and methods better than what is practised by others. More often, you will always need to support your unique ways of doing things to satisfy the auditors - leaving most of us going for the safe approach and instead 'follow what others are doing.' Thus, lacking in creativity.

Another 'problem' of the GMP guidance is its non-specificity. For example, does a buffer room require an interlocking system? Why can't you release your products direct into a Quarantine room; from here it is released directly to the approve store? Must you need a buffer room for finished goods before going into a quarantine room? Is it compulsory to have a quarantine dedicated area, or can we use flexible methods to identify quarantine items, such as by ropes and quarantine labels.?

There are many more issues pertaining to GMP guidance. I hope I can have some comments or share of experience from you all out there....

GMP Training

We in Malaysia are not short of GMP trainings. MOPI and NPCB play active roles in providing and organizing relevant GMP trainings for the industries.

However, some of us may feel that the fees imposed are on the high end. Average charges is RM2,000 per person for a 2 days program, inclusive of training materials and refreshments. This is not inclusive of travelling and accomodations.....
[ Note: NPCB own training program are much cheaper, rarely exceeding RM500 per person for a 2 days program.]
Although we feel that this is expensive, it is relatively cheaper than the rates in Singapore. There are much more GMP training programs there and all are well attended by locals and foreigners.

Why expensive? This is purely to the fact that such training programs are highly specific and conducted by experienced people. You have to pay to get such knowledge and experience....

An alternative is to conduct an in-house training program. This is value for money as you'll be able to transmit the knowledge to more of your personnel. Check your target group.... if you need to train only your new executive, supevisors and below, why spend so much for a foreign trainer? You can easily get a local GMP trainer for such needs. The rates are cheaper, and the plus point; you can also claim 50% from the HRDF for such training program.

So, consider this point when you plan for your personnel training next time.

AJ.

Murphy's law

I always remind my client to abide by Murphy's law. Things can go wrong and it will always go wrong at the wrong time.
Many pharma manufacturers have been caught with this situation but only a few learnt their lesson well.
There are still many manufacturers who choose to give more priority to meeting sales demand rather than keeping an eye on their GMP state of compliance. When we get too comfortable, we tends to overlook the common mistakes and non-compliances, to the extent that it becomes 'normal'.
It will take few rounds of audits by the GMP auditors before the bad state of non-compliance get noticed and warrants a suspension of the manufacturing operation. Only when this occurred, the alarm bell will immediately be sounded in each of the management's head and trigger finger pointings. But alas.... this is too late. Damage is done.!
So, what's left next is 'damage control'. With the operation suspended, the affected manufacturers will now have ample time and space to rectifying all their problems and hopefully get back their manufacturing license within the shortest time possible.
But wouldn't it be good if efforts are taken before the suspension is imposed...??

AJ.

Process vallidation

It came to a surprise to me that some pharma manufacturers, especially OTC, are still not aware of the needs to conduct process validation... Our DCA has made this compulsory for product registration in stages since last year.
Being not aware is one problem.... Being ignorant is worse..! Manufacturer's should take effort to equip their personnel with the required knowledge and skills. Process validation is not only meeting GMP requirements and ensuring your GMP license remain valid. It is much more than that.
With validated process, you can rest assure that you have good control and your process, and able to consistently produced output that meets the quality criteria you have pre-determined. You will have peace of mind.
In a world where patients are now knowledgable and more demanding, this is one aspect of GMP you cannot do away with...!

AJ.

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.

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.

Lab Asia 2009

Do you know that Lab Asia 200 is coming soon to PWTC, KL. It'll be open from 11 to 13 August 2009.

This is the place if you are searching for suitable instruments and analytical tools for your qualty control lab. You will also be able to view and experience any new technologies introduced.

To know more, go to http://www.lab-asia.com/asia/index.html

And block your diary to ensure you do not miss this golden oppotunity.