Sunday, May 31, 2009
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.
Friday, May 29, 2009
Keep it up!
Thursday, May 28, 2009
- 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!
Wednesday, May 27, 2009
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.....
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!"
Saturday, May 23, 2009
Monday, May 18, 2009
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!
Thursday, May 14, 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.
Sunday, May 10, 2009
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....
Saturday, May 9, 2009
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.
Friday, May 8, 2009
Thursday, May 7, 2009
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.
Wednesday, May 6, 2009
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).
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!
I welcome any comments and inputs from you any anyone else who read my blog.