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!