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

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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You will not be punished, but your submission will be withdrawn or rejected.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.

HVAC qualification by supplier/contractor

In pharma industry, any new installation or major upgrading of HVAC (Heating, Ventilation and Air Conditioning) servicing the processing area requires qualification.

Seems to me that most of our pharma industries adopt a safe attitude by requiring qualification as part of the requirements which a potential supplier or contractor has to comply. This trigger the supplier or contractor to look for a GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.

However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.

The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?

Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.

AJ.

Microbial test for Purified Water

The latest BP method is by microbial filtration, utilizing a sample size of 100ml.
I find this method as not suitable compared to the older method of pour plate using 0.1 to 1.0ml sample.
Consider the fact that microbial limit for Purified Water is 100 cfu/ml. If you have 10 cfu/ml, a sample of 100ml will show you a result of 10 x 100 = 1000 cfu. Can you count this much cfu..? What if your sample is 20 cfu/ml, or more....?

Thus, a sample size of 1ml using pour plate method will neatly fit this situation. Most samples o Purified Water will be more than 10 cfu/ml and this will show well on the agar plate.

However, if you consistently achieved a level of less than or equal to 1 cfu/ml, then you should adopt the new method using microbial filtration and sample size of 100ml.

Anyone out here having problems with microbial test on Purified water that you can share..?
We'd like to hear form you!

AJ

GMP Consultant = Consultant Engineer ?

I had this peculiar encounter with a bunch of consultant engineer (M&E and C&S), plus an architect. I have submmited a conceptual layout on the location for dainages and separate them between those to be directed to a sewerage system and another to a waste treatment sump (as required by Dept. of Environment).

Seems this is not enough.... They want me to provide the draine slopes, the pipe details (size and materials), exact X-Y positions of the drain holes and presented in an auto-cad drawing with scale 1:200!

If I'm able to do all these, I might as well assume the position of an M&E consultant and charge a higher fee !

Actually, GMP Consultants provide only the conceptual design of the facilities and utilities, whereas the Consultant Engineers provide technical and engineering input. For example, a GMP consultant provide the HVAC requirements specifications, but the engineers will calculate and size the required equipments and provide the technical drawings for construction.
Yes, that's how we can work as a better team..!

Got it...??

AJ