Monday, April 27, 2009

IIUM Pilot Plant near completion

Just came back from Kuantan today after visiting IIUM Pilot Plant. Looks like its almost 'ready' for all equipment to come in.

Key personnel has been interviewed and those suitable should be given the appointment letter soon. Congrats to those selected! These are indeed capable people who will serve the Pilot Plant and Kulliyah Phamacy well. How I wish I'm young enough to be part of this Pilot Plant -as a permanent staff.

However, water system has yet to be installed and pipe work yet to be completed. I guess the water room is not ready for the contractor to bring in their equipment. Where are the promises...???

Internal rooms need to clean up. It's still a mess with leakages from dunno where... Believe me, the microbes there should be the happiest creatures around..!

Internal staircase yet to be completed. Speakers are seen dangling from ceiling. Fire door yet to be painted and utilities opening in panel yet to cover up. And where are the furnitures and sinks...? Must be same security issue with the water system - no security, furnitures cannot come in for fear of it being taken away by someone who loves staineless steel for their home.

I do hope the main contractor will do their best to put things back in order. Buck up guys!

For all the equipment supliers out there, be ready to install and commission all your equipment after 18 May 2009. Hope by then, all key personnel will be there to supervise and witness the installation & qualification....... Isya-Allah!

Sunday, April 26, 2009

The weak link.

It worry me to realise that many of our Malaysian manufacturers choose to ignore the risk we faced when many of their operation personnel are inadequately trained. The percentage is higher amongst the cosmetics and traditional/herbal product manufacturer, as compared to the pharma.

Yes, most of us acknowledge the importance trainings play to ensure compliance to set procedures and GMP requirements. GMP auditors too always look into this matter during their surveillance audits. But how many actually put in concerted effort for a proper training need analysis, and plan their training program...?

'No problem' one might say, and add, 'Just send to any one of the GMP training program available'.
But then, how many personnel can the company afford to sent to such trainings? Mind you, most of these trainings are expensive....... How often such training are available? And are these training tailored to meet the participants' organization needs?

While external trainings are considered useful to accquire new knowledge and achieving a higher level of competency, I find internal trainings as the most dependable tool to ensure that ALL operation personnel are adequately trainned to execute their job functions and to understand (and thus comply) to the numerous GMP rules and requirements.

Get a subject matter expert (SME) in the organization to 'teach' subjects best know to them. If such SME are not available, do not fear to fork out a small sum of money to engage external SMEs for conduct on your internal trainings. Get your calculator and calculate the cost you incur by calling an external SME to train your few groups of personnel. Add the saving you obtained from your personnel travelling and accomodation (as required for external training), you'll easily concur with me the substantial savings you 'accquire'. What about the benefits you get when such trainings are specifically tuned to meet your current needs...? You can't value that.!

So dear fellow friends..... plug that weak link in your operation. Do something to improve GMP compliance. Conduct internal trainings.!

Saturday, April 25, 2009

Water system: DI or RO?

This issue seems to trouble many new starters in GMP. Should the water purification be deionization (DI), or via reverse osmosis (RO)?

The answer actually lies on the final output desired. The output quality must be able to achieve the desired specification for a Purified Water, usually in compliance to BP or USP. So, you can use either DI, or RO, or combination of both, as long as the final output meet the pre-determined specification.

The difficult and expensive portion is to ensure that the water purification design is able to consistently produced water of the desired specification. There should be a pre-treatment water treatment system, before the actual purification stage. Contact materials used after the purification stage, should be inert and not promote microbial growith, and there should be no dead legs that allow 'obstructive' flow within the water system.

Put your trust in the expert to design the best water system, that falls within your budget. Do not take risk by designing your own system if you do not have the experience and knowledge in this subject.

Finally, always qualify your water system before using it.

Interphex 2009 in Singapore

Date: 31 May to 02 June 2009.
Don't miss this opportunity to get yourself updated with the latest trend and practises in pharma industry. You get to hear from the experts, make contacts, and what I like most, is the chance to visit a well established pharma plant. You won't be able to walk into them unless you have good reasons!

There are few exhibitors, but not comparable to Achema..! But it'll do you good as you need to spend more time in the conference.

Trust me, you'l really enjoy this conference.


ACHEMA 2009 is just round the corner. Frankfurt , Germany has been the main venue for this exhibition. I can say that this is the biggest exhibition of pharmaceutical machineries with the latest technologies being promoted to visitors. Other related materials are also exhibited. Glad that I'll be there from 11 to 14 May 2009.

I have a FAT to conduct on behalf of IIUM, for a High Speed granulator, purchased from Diosna. Since all fares are paid for, I might just as well extend my stay in Germany to attend this glamorous Achema...!

Meet me there! Will keep you posted after my trip.

For details on Achema, go to

FAT in Shanghai, China

GMP requires new equipment be pre-inspected before delivery to processing site. This gives us opportunity to verfiy that the Design Specifications comply to our User Requirement Specifications (URS) and also an opportunity to travel!
This FAT is for a tablet coater in Shanghai, China.

Picture on right is us at Yang Garden.

We then moved on to Shanghai river bank and admire the cherry blossoms. Never hold one in my life.......

And that's us by the river.
As the saying goes.... 'All work and no play makes Jack a dull boy'.
So, we work, then 'play'..... hehe....