Prelude to Interphex 2009, Singapore

Well..... here I am in Suntec City, Singapore, for the Interphex 2009. The program starts with pre-conference workshop @ 1:30pm, and I'm not missing this 4hrs workshop on Commissioning and Qualification. Issues discussed will be based on the Baseline Guide issued out by ISPE.

I leave home 8:45am (today) from Melaka, and arrive here at 11:30am. I sort of expected a 4 hours journey with traffic congestion at the causeway, customs and imigration checks..... but here I am, earlier than expected.

Alhamdullilah (Thank God) that this Interphex is located in Suntec City. Here, it is a huge shopping complex, with lost of shops, restaurants and entertainment. There are few fast foods with 'Halal' status. So, this will keep me busy till 1:30pm. We even got free wireless here.! That's why I can blog now..... Life couldn't be better.
I'll write some more tonite on the workshop. Hope the workshop is as expected and better than previous years.

AJ.

Purified Water generator unit

Let me first declare that I'm not getting any rewards for writing this, but I can't refute TK Lee that he indeed has a good and simple, yet a complete and rugged product to generate a consistently high quality of Purified Water BP/USP.

[Note: TK Lee is the Malaysian agent for Christ products]

See the picture on the right. Yes, it's none others than Christ's Osmotron Pro Unit. I saw this during the Achema 2009. Well... they do have other better models, but just take a look at this one first.

It is neatly arranged, short pipework, yet easy access to critical components making maintenance and monitoring work very easy. Your engineer will love this piece of equipment.

It is designed to include softener as pre-treatment, other than the usual filtrations , RO (reverse osmosis) and an EDI (electro deionization). You are damned sure you can easily get the water conductivity and the low microbial load that you require. Getting conductivity below 1.0 micro-siemen per cm is no big deal for this guy. Do you know that micro-organisms can't stay alive in an EDI, unless they comes from planet Mars. Hehehe..... just pulling your leg on that planet Mars issue, but it is a fact that EDI also kills all micro-organisms. I'll try to write something about this EDI in my future blog so you'll know how exactly it works.

The necessary monitoring instruments are all in place for this Osmotron, and what further amaze me is its ability to stay 'alive'. Yes, it has a system to recirculate the purified water when there is no demand from the points of use. This drastically reduce the risk of microbial proliferation or bio-film formation within the generator unit itself. And this is done automatically.... No worries mate.

Unfortunately, I somehow tends to equate this Osmotron to a Ferrari, in contrast to what I used to have when I worked in a pharma industry. My old unit was more like a Proton Waja...... cheap with basic function, but doesn't 'run' like a Ferrari... and we cannot afford a Ferrari back then. =(

Actual cost of this Osmotron.....? Well, I dare not ask for the price unless the need arise. TK Lee said it's not expensive comparing to what it can do..... It sounds like a familar sales talk, but I do concur with him. Price is relative and subjective. I would prefer a water generator that can guarantee me the water quality I wanted, rather than worrying on a cheap unit.

Yes, someone out there mention qualification....? That's a piece of cake to these guys at Christ. What more with this simple Osmotron unit, their technician won't even sweat!

I won't say more. If you want more info, or know the actual price, just let me know and I'll give you TK Lee's mobile no. He'll be glad to hear from you. Maybe, I will spend more time with him on this matter... soon.

Azman AJ.

GMP for Veterinary medicines

I believe you all know that soon registration of veterinary medicines will take into effective legal control. Without doubt, the manufacture of such products will require GMP certification. That's why now you see many (but not all...) of these manufacturers working hard to get GMP in place for their existing or new facility.

However, take note that animal vaccines are not covered. Yes, animal vaccines do not require registration with the DCA, thus its manufacture do not require GMP. See section 2.2 on 'REGISTRATION GUIDELINE OF VETERINARY PRODUCTS (REGOVP), Version 2' as issued by NPCB, dated August 2008. You can get this from the Veterinary section of http://www.bpfk.gov.my/

On second thought, GMP is a noble thing.... it ensure consistent safety, efficacy and quality of your product, right? So, why throw it aside? We should not adopt GMP out of legal obligation, but should better be out of our committment to our professions and ethics.

I'm glad that there are many of these animal vaccine producers, who are indeed professional and ethical enough to consider compliance to GMP as one of the criteria for their new facility. This is good for the company image and reputation, and also improve their chances of penetrating any overseas market, especially the developed countries.

Keep it up!

New edition of PIC/S GMP Guidance, PE009-8

Note that this guideline is now updated for the following:
- Revision of Chapter 1 (Part I);
- Revision of Annex 1;
- Adoption of Annex 20 (voluntary).

It has been effective from 01-March-2009. So download the latest version from http://www.picscheme.org/publication.php?p=guides
It's free.... don't worry!

Impact of 'failed' GMP projects.

Of late, there are few GMP project in our country that were delayed due to inability to fulfill the requirements of GMP, thus not able to obtain the precious GMP license for operation.
I never knew this could affect any of us. The delayed or failed project seems to adveresly affect those new in the field of pharma manufacturing.....
Last week, I was shocked when I was informed that my client's application for loan was stucked. The bank has imposed a new condition of 'obtaining a GMP license' before my client's loan can be approved..!
This is simply ridiculous. It's just like requesting a developer to show the certificate of fitness for the building before the loan can be approved.....
So, I went with my client today to meet up with the bank officer and try convince them that their condition is impossible to meet. If we have the GMP license, we will already be in operation and do not need their money anymore!
So, explain I did, in all aspects of GMP, insisting that we have obtained approval for the design layout and put all perspective in place, right up to personnel. But it was in vain.
Since the bank has bad experiences with most of their pharma clients, where there were delayed in obtaining GMP license (and the bank claim that as a failure.... due to late re-payment!), the bank management now wants a 'guarantee' from someone reliable & capable to assure and guarantee the success of this project.!
By right the guarantee should be the CEO or board of directors (BoD), but this is not to the bank preferences.... they wanted someone like the Architect, engineer, consultant or project manager to give the guarantee. No one from these group of people can give such extreme guarantee...
It seems that they will accept guarantee from the CEO if I'm the CEO. So guys, don't be surprised if I informed you I'm a CEO in my next blog..... hehe... mimpi lah!
It is easy for the bank to demand for a GMP license, when in actual fact it is actually impossible to the borrower. Who in the right mind will want to give a guarantee of success when there many variable factors for the success...?
There are issues of building, facility and utilities, and their qualifications.... there are issues of equipment and its qualifications.... there are issues of systems, processes and documentation.... there are issue of personnel adequancy and competency..... we have process validations...... issues of maintenance.... and many others. So, the success (ability to get GMP license) all lies in meeting all these variables. We always PLAN FOR SUCCESS, BUT WE CAN NEVER GUARANTEE SUCCESS (unless you are God!).
So, who else can consolidate and ensure these variables are all met other then the CEO or BoD..? (be they knowledgable or not in GMP), right?
It seems my client now face a solid wall to their project. I don't know yet what we will do, but once we are able to unravel this pecualiar situation, you guys will be the first to know.
So, keep posted.....

Adios to Students from Kulliyah Pharmacy, IIUM !

Thanks Bros & Sisters...!
You made me feel appreciated by linking my blog to yours. I promised you that I'll be more aggresive and more frequent in my discussions of cGMP matters.
If you have any issues to be raised, feel free to let me know. It's good to share knowledge. Like my mentor used to say, "Knowledge shared is knowledge gained!"

Stainless steel or PVC pipes in water system?

It is the norms that for pharma water system, we require SS316L, internally polished to less than Ra 0.8 micron, for piping from the purification stage to storage tank of purified water and to the distribution loop.

Some may go beyond this to have the same pipe quality for piping in betwen the RO system. While this is acceptable for RO system, we cannot assume the same to be for a DI system, especially a twin bed resin system.

Why not?

The simple reason is due to the requirement for self-regeneration for a DI system. Acid, such as hydrochloric acid, and alkali, such as sodium hydroxide, will be used to regenerate the resins. As we know, acids & alkalis are simply corrosive to SS pipes. This serve to place high risk to the purification system itself and to the quality of the output water .

So, be conservative and stick to the usual cheap PVC pipe for connection in between the DI unit. Don't simply overdo and put your own water system at risk.