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.

To have own plant or contract manufacture?

I just met a potential client who has only one product and desire to build a GMP Plant. He's dammed surprise to hear the cost and hardship that will face him. Then, why can't he just contract manufacture...?

Always this is the dilema faced by a product licensed holder who is new in this field. Constructing a GMP plant is not as simple and cheap as a 'normal' processing plant, say for a food industry. The construction materials used, the finishing, utilies, equipment and system controls will not make it easy for you.

So, unless you do have solid grounds on having your own GMP plant, or have adequate sales volume, then only having your own GMP plant will make sense.

If not, go for contract manufacturing dear..... there are many GMP manufacturers out there who are eagerly waiting for this job, some to make up for their unused capacity they possessed and others to cover their operational expenses!

A smart businessman will start with having his products established first in the market, get the sales volume to build up, by just contract manufacturing all his products. He will have no headache on the plant investment, maintenance and operation - just concentrate on marketing and sales! How good can that be...

But on the bad side, my client told me that his formula can be copied. Yes.... that's partly true if the contract manufacturer has low ethics value and professionalism. However, why worry....? someone can have the same product from other source too. You can now have well known brand being copied easily, which I think is far worse than having someone 'copied' your formula and with a different name.

The previous company I worked in had their saleable product copied by someone. Almost all aspects of the product are the same, except for the product name. But yet, the product can't sell as well as the 'original' product. The aggressive marketing strategy makes this product hold well in the market.

So, my advice to those 'small volume' product owners, do away with having your own GMP plant for now. Look for a good cintract manufacture, wirk with them and make your money first. Once you have enough sales figure, then do come to me on how you can set up your own GMP plant.!

Adios!

Achema 2009

Finally I arrived at Achema 2009. Venue Frankfurt, Germany. It really is a good show with so many exhibitors around. There are 8 exhibition halls, with some halls more 3 levels. And believe me, you will need all the 4 days to finish all.

I have only 2 days and spend my time more on the pharma processing & packaging equipment, and water system. There were IMA, Korsch, Bosch, Bausch & Strouble, Romelag, Wilco, Quadro, Ludige, MG-2, Glatt, GEA, and many more..... some never heard of before. I simply couldn't find time to cover all. Maybe this will be a good reason to go again for Achema 2012!

I don't see many Malaysian, except 3 equipment suppliers. I may have missed them amongst all the crowd. Just too many people around you......

There are many new technology on display. But don't ask for the price. All in euros lah...!
We can ask many questions to their experts and get satisfactory answers. Food are abundant. I don't even have to spend any euros to have my stomach filled and my thirst quenched.
Only problem is the heavy load to carry - with the many brochures given away.....


Make it a point to come to Achema, at least once in your lifetime. This is one experience you will treasure forever.

On the road to Achema - Part 2

Well..... what can I say....?
Here I am in London, posing in front of the famous Buckingham Palace. Too bad the Queen was not there to greet me....

Tour in London is easy with their city day tour package, which includes boat cruise along the Thames River. Cost me £24. Sounds cheap, but convert to RM... Cheap now?



Behind me is the Big Ben and House of Parliament, where the Ministers are now defending allegations that they have misuse public funds by making un-reasonable claims!
Other than the rebate of £2000 offered for scrapping a 10 year old car, this allegation is the hot political topic now in London.







I got off from the boat cruise at Tower bridge and took this photo. Some of you may think this is the London Bridge - actually London Bridge is not this. This is the Tower Bridge. !
The song 'London Bridge is falling down refers to the bridge 'collapsing', not the bridge center closing after making way for big ships to pass through..

Sorry, some info there that is totally non-GMP....

The road to Achema

Phewh.... The FAT in Germany and the waiting to Achema gives us (me & Kausar) a chance to travel Euro! We took train to Amsterdam, stay one night and have a good tour of the famous city.




The canal cruise was simply great.
Eat your hearts out....!







Next trip to London.

Will keep you all posted once I've settled down and organize myself.

Picture on left show me getting on the Euro train to London, via the English Channel tunnel.

Blog from editors of Pharmaceutical Technology

This is a very resourceful and interesting blog for those involved in the field of pharmaceutical industry. Go to http://blog.pharmtech.com/ You will be able to read blogs from various editors of the Pharmaceutical Technology journal.

How to get more info on GMP ?

Where can we get our supply of knowledge on GMP practises? For this question, I strongly suggest you subscribe to ISPE and PDA.

ISPE is International Society for Pharmaceutical Engineering. It cost only USD 40 for an annual fee to members feom 'emerging economic contries' like Malaysia. I paid jst that. Log on to http://www.ispe.org/ for more info. Being member, you get to access their website containing full of useful and up-to-date info on cGMP practises. ISPE also organize numerous GMP trainings, usually overseas. A conference will be held in Singapore soon, from 31 May to 2 June. Scroll down my blog for more info on this conference.

PDA is Parenteral Drug Association. Log on to website http://www.pda.org/ for more info. This association deals with hard stuff in GMP, especially on sterile pharmaceuticals and bio-pharmaceuticals. Membership fee is USD 249, but it only cost USD100 for members from economic developing countries (as classified by the World Bank). I'm not sure about this as I paid the full USD 249....

Members get regular newsletters containing news, discussion and short articles, and journals on various studies done - all related to pharma industrial practises. Many good books are also produced by PDA dan numerous good trainings and conferences are held regularly, all over the world.

Just being members to these two organization will keep you busy keeping up with the vast info presented. I know, coz I find it tough to finish reading all the newsletters, journals and articles provided by them.

These 2 subscriptions are really worth your money spent. Trust me!

FAT for Diosna High Speed Mixer.

Germans are really good. I'm having fun doing FAT for this high speed mixer-granulator. Capacity is small but well equipped with controls and safety features.
All controls via PLC touch screen control panel.
Mixer and chopper speed are adjustable and we also have temperature probe to monitor the product temperature.
The best thing is this machine comes with a wash-in-place (WIP).
Simply wonderful!

Is change a good thing in GMP?

Change for the better is always good, not only in GMP, but in any other matters. However, in GMP, you cannot simply change as you wished. GMP is about maintaining order and ensuring consistency in meeting the quality parameters of products. So, while some changes are genuinely good, we are not allowed to assume it as such in a GMP environment.

There are many instances whereby a manufacturer had a good start, having all utilities, equipment and processes qualified and validated. But after a period of time, product defects start to creep up and bad incidents grow in numbers. I bet you all these are mainly due to changes done by some smart guy, without proper control and approval.

As a rule of thumb, always assume change as something that is not wanted, or presenting risk to product quality. Resist change. Be on the offensive to any proposal for change. It may sound like you are a person with a 'closed mindset', but this all need to be done to safeguard the interest of GMP.

Any change proposed, be it from the from the lowest rank personnel in the organization, or from the top person (CEO), must undergo systematic scrutiny and levels of approval. This is more crucial for validated processes whereby efforts have been taken, painstakingly, to prove that the process is capable, effective, reliable and robust.

Look at the proposal for change, critically scrutinize and seek for justification before accepting it. Get the 'subject matter expert' to approve and the QA Manager to authorize the change. Plan what need to be done to get the change executed and outline procedures to ensure that the change do not affect the final quality of the product. If necessary, re-qualify (for equipment and utilites), or re-validate (for processes). NEVER TAKE CHANGE AS A MINOR ISSUE!
Most importantly, record all the actions and decisions that took place.

The change management itself must have authorized written procedure to ensure reliability and consistency in handling of changes to any part of the operation.
Any changes in the ' Change Procedure' must also undergo the same procedure before the change handling procedure is effective.
Sounds a little winding, but think carefully..... it does make sense!

Welcome to my followers!

Thanks Dr Kausar and Bro Ilham for being my followers. I will return your good favor with many in-sights on GMP matters - very detailed issues frequently ignored or taken lightly by "GMP practitioners".
I welcome any comments and inputs from you any anyone else who read my blog.

Rgds,

Osnabrück, Germany

Here I am.... in Osnabrück, Germany, along the Krahn Strausse. What am I doing here? Well, tomorrow me and Dr Kausar will perform Factory Acceptance Test (FAT) on the high speed mixer-granulator that IIUM bought from Diosna. Arriving early today, we decided to explore this town ourselves. Tomorrow we work!