tag:blogger.com,1999:blog-7013946613947828612012-02-16T17:28:37.561+08:00Discuss Pharma GMP related issues.Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.comBlogger581100tag:blogger.com,1999:blog-701394661394782861.post-23570733820430840542010-08-02T16:23:00.003+08:002010-08-02T16:27:17.504+08:00

If you are a GMP practitioner, you must join ISPE as a member. The benefits are numerous; amongst which are access to good training notes, info on training conducted all over the world, updates and even forums.It is best that you visit the website www.ispe.org.my to know more. Enrol as member if you are convinced.!

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-38918247453770187952010-08-02T16:04:00.002+08:002010-08-02T16:17:54.928+08:00

Unza manufacture only cosmetic products, but their commitment to train their staff on GMP matters are something we should salute.Today, we conducted 2 sessions of training on 2 different groups of 23 line leaders and operators. Tomorrow, there will be another 2 sessions on different subject matters, on another 2 groups.Unza started this GMP training few years back, starting with the high level

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-69135339031047754502010-06-05T17:49:00.002+08:002010-06-05T17:59:30.016+08:00

Doing GMP consultation work can be very demanding and risky. While it does gives me the satisfaction when job is done and completed, the problems in between really can get on your nerves.I have one job in the East Coast where the facility is almost ready..... If you are running for one km, I can say that this is the last 50m. But the facility owner run out of cash to push the project to its end.

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-85704434706961985332010-05-17T14:04:00.002+08:002010-05-17T14:10:52.396+08:00

In pharma plant, everyone get tired with the routine work. Too tired and too pre-occupied with work that no one has the time to re-look at current systems, review documents, monitor test results and analyse trendings....How to improve...?

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-59511543293565005992010-04-09T16:40:00.002+08:002010-04-09T16:51:16.767+08:00

Doing work as a consultant brings me to see many facilities. I am amazed with the high numbers of licensed manufacturers being unaware of the needs to conduct stability studies for all registered products; be it theirs or products owned by others (contract givers).It is prudent to note that the responsibility is on the product licensed holder to conduct a Real Time stability study as per the

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-73496217802547997252010-03-26T16:11:00.003+08:002010-03-26T16:23:15.617+08:00

Bravo! Finally we see some light to the end of the tunnel for this Pilot Plant. It is usual to have glitches here and there, but as long as the management understand and cooperates (in terms of financial assistance), I am sure all problems can be solved....The waiting still prevails. We still have some minor loose ends with the utilities qualification. Few more equipments are pending

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-16239343547880029472010-03-24T07:22:00.004+08:002010-03-24T07:48:42.004+08:00

GMP guidance provides ample guides in ensuring the safety and quality of drugs manufactured. As the name implies, it serves only as a guide, not as a rule that you MUST follow.This leaves us a lot of freedom to implement methods most suitable to our own needs, and methods better than what is practised by others. More often, you will always need to support your unique ways of doing things to

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-60199482298300456372010-03-06T16:40:00.002+08:002010-03-06T16:57:32.339+08:00

We in Malaysia are not short of GMP trainings. MOPI and NPCB play active roles in providing and organizing relevant GMP trainings for the industries.However, some of us may feel that the fees imposed are on the high end. Average charges is RM2,000 per person for a 2 days program, inclusive of training materials and refreshments. This is not inclusive of travelling and accomodations.....[ Note:

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-18691134460365158112010-02-20T22:42:00.002+08:002010-02-20T22:54:15.948+08:00

I always remind my client to abide by Murphy's law. Things can go wrong and it will always go wrong at the wrong time.Many pharma manufacturers have been caught with this situation but only a few learnt their lesson well.There are still many manufacturers who choose to give more priority to meeting sales demand rather than keeping an eye on their GMP state of compliance. When we get too

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-16099093749191307272009-12-07T22:36:00.003+08:002009-12-07T22:45:54.225+08:00

It came to a surprise to me that some pharma manufacturers, especially OTC, are still not aware of the needs to conduct process validation... Our DCA has made this compulsory for product registration in stages since last year.Being not aware is one problem.... Being ignorant is worse..! Manufacturer's should take effort to equip their personnel with the required knowledge and skills. Process

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-43830824036396960192009-10-17T10:10:00.006+08:002009-10-17T10:21:56.876+08:00

I personnally do not know him but I find this guy, Lex Rudd, a very generous man. Wonder if he got any relationship with the Australlian PM...... ;-) N'way, visit his site at http://www.pharmscience.com.au/ and subscribe to his newsletter at no cost. You will find that Lex share with us numerous helpful tips and info on GMP matters.Not enough? Need to know more? Contact him for a GMP

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-13042995239687425572009-10-15T12:41:00.004+08:002009-10-15T17:43:12.175+08:00

The Kulliyah of Pharmacy, Islamic International University of Malaysia (IIUM), plans to provide a master program in Industrial Pharmacy by year 2010. This will be a 15 months course work to equip students with the basic needs for practising in the pharmaceutical industry.I find this program suitable for those who wish to venture into industrial pharmacy and those already in the industry but wish

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-87001353268485288192009-10-10T17:37:00.002+08:002009-10-10T17:55:01.333+08:00

Everybody knows that documentation is critical in GMP, but not Anybody can assure of a good structured system of documentation to supplement the good process and GMP control in the facility.Somebody need to be in the reign to control and monitor GMP documents and not leave it to Anybody to do it, cause it will end up with Nobody doing anything on documentation.....[just relating the story of the

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-51855815713974644752009-10-07T20:53:00.007+08:002009-10-10T17:36:09.853+08:00

This training was organized by Malaysian Biotechnology Corporation for Bio-Nexus status companies. And it was free of charge! Training done at Istana Hotel - good environment and good food...... En Lukmani from the GMP Compliance div. of NPCB came to give the first paper and the rest by A1 Consultancy.We expected only 20 participants but ended up with more than 30!Many critical documentation

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-53617097028427086022009-09-10T08:18:00.002+08:002009-09-10T08:35:33.732+08:00

It is year end and the GMP auditors should now be busy meeting their surveillance schedule. GMP license holders should now be ready for such audit as these audits are on a surprise basis. We do not want you to be 'surprised' and faced with a compulsory shut down..!I know most of the managers shiver thinking of the coming audit, but it is actually not that difficult to prepare for an audit. Why

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-40018254396824386692009-09-06T06:20:00.002+08:002009-09-06T06:38:07.876+08:00

It really is a burden when asked to qualify a new plant that is almost completed...!I have this unfortunate incidence whereby the owner requested for my service to qualify their plant, after the 'qualification' done by their respective supplier was found not to be in compliance to GMP.Suppliers are not to be blamed. I blamed the M&E consultant for their ignorance in differentiating the '

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-48697164225697570712009-08-21T17:57:00.006+08:002009-08-21T18:10:15.566+08:00

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 .This is their new

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-56885576015211586842009-08-17T21:28:00.004+08:002009-08-17T21:39:19.147+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com2tag:blogger.com,1999:blog-701394661394782861.post-2340877990476086472009-08-08T22:14:00.002+08:002009-08-08T22:20:44.028+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-55622067735481639422009-07-25T21:22:00.002+08:002009-07-25T21:27:52.632+08:00

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.htmlAnd block your diary to ensure you do not miss this

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-21829825672054739242009-07-25T20:22:00.006+08:002009-07-28T23:31:06.409+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com1tag:blogger.com,1999:blog-701394661394782861.post-423006086056251732009-07-25T20:01:00.002+08:002009-07-25T20:16:00.326+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-20960003064010723402009-07-25T09:01:00.005+08:002009-07-28T23:31:30.357+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-43314661690284616732009-07-25T08:48:00.008+08:002009-07-25T09:00:38.542+08:00

This is not GMP matters. It just that a friend adviced me, or any other Malaysia, from eating this chocolate as it may make you dumb.I know how far this is true. Maybe for fellow Malaysian only..... This chocolate named 'Bahloul', comes from an Arab country.Any one for a BAHLOUL choc...!

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-48972282602761275822009-07-25T08:27:00.008+08:002009-07-25T08:46:36.140+08:00

I gave my lecture on tablet processing at the new building of Kulliyah Pharmacy, IIUM, Kuantan on 20-Jul-09. It sure was a grand experience.Although not fully ready, I can say that the occupants simply 'barge' in and make it their home. What better ways to force contractors to complete their work.....? I salute you guys..! Finally, the Pharmacy faculty has their own building. They have been

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-24279619114893243602009-07-12T14:10:00.002+08:002009-07-12T14:18:00.377+08:00

The dateline for submitting existing veterinary product recently ended on 30-Jun-09.Many were frustrated at no being able to meet this dateline. There were many documents unavailable and getting them is a real tough job. Documents such as certificate of free sale, and GMP manufacturing license, as well as stability study and materials certificate of analysis..... all these presented problem to

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-36242473380575724172009-07-05T23:19:00.004+08:002009-07-05T23:33:56.311+08:00

Now that the dateline for registration of veterinary medicines is over, I can divert my focus to my routine jobs. Things were abnormal during submission of the vet medicines before the dreaded due date.Now need to focus on the plant design and construction of vet medicinal manufacturers. Got a small handful of jobs on this, but enough to keep me busy and survive....Although the standards to be

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-32752423461060646872009-07-05T18:46:00.005+08:002009-07-05T18:58:51.619+08:00

It was one week since I last blog. I have many issues to write but this one really stunned me.Some of you may have received this circular from NPCB, dated 16-Jun-09, requiring that certain information be located at a stipulated location on the label. See attached draft.I do no doubt the benefits to consumers, but I feel this restrict the creativity by the product owners...Label shape can varies,

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com2tag:blogger.com,1999:blog-701394661394782861.post-90314725102140384032009-06-29T09:20:00.005+08:002009-07-12T14:20:52.118+08:00

Universities are now offering courses in Industrial Pharmacy in their syllabus.I salute this effort as the industries has long been waiting for pharmacists with such skill and knowledge. Currently, industries have to 'adopt' the fresh graduate and train them in all aspects of industrial knowledge, especially on the GMP requirements. Where can you get 'free' training and being paid a handsome

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-5839371363808457062009-06-25T14:28:00.008+08:002009-06-25T15:02:13.916+08:00

Some of you may think so.... but think again.... On contrary, we consultants make life easier for the regulators.Not all the manufacturers and importers are well versed with the laws and guidelines as laid down by the government and Drug Control Authority. Understanding them is one problem, and with lack of experience in this field, the problem multiplies.I can see the regulators' sincere needs

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-57787553402084481722009-06-12T10:39:00.004+08:002009-06-12T10:59:41.759+08:00

Wow... These few days were very busy with work.To make matters worse, veterinary products must be submitted for registration before 30-June-2009. And some of my clients just hand over their handful products last week....! I have to decline for those who just requested me to register for them. I am sure there are some other consultants with adequate resources to handle them.Another matter that

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com1tag:blogger.com,1999:blog-701394661394782861.post-1991994398209260872009-06-07T12:49:00.007+08:002009-06-08T14:06:57.208+08:00

Time flies, and it's now almost to the dateline for registration of verterinary medicines. The last date is 30 June 2009, which is less than one month away.As part of registration requirements, local manufacture need to produce at least a Letter of GMP Compliance, although some say that a letter of submission for plant GMP layout will suffice.The pertinent issue of concern to many is the needs

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-86126843862450071482009-06-04T10:13:00.005+08:002009-06-04T22:56:57.707+08:00

The plant visit organized by ISPE yesterday was really informative. I went to visit Norvatis plant in Tuas, Singapore. This plant currently manufactured tablet products.But oh my.... the extent of technology and controls put in was simply fabulous and I felt lucky to be able to experience it.Handling of materials was given great emphasis and Norvatis practise a close system as far as they can.

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-68322900540283363652009-06-02T18:40:00.003+08:002009-06-04T09:43:15.285+08:00

I was too tired yesterday to write on day 1. We had a dinner function that lasted till 7:30pm. Ms Cheng Mei Fen (Xepa Soul) was the only lucky person from Malaysia to win one of the lucky draw on that night.Today’s topics are heavy and very related to the industry. Today is the second day of this conference and I can tell you for sure that it do exhaust your mind. It is so packed with facts and

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-1924228160164269692009-06-01T10:59:00.005+08:002009-06-01T11:06:15.196+08:00

Wow! The workshop on Commissioning & Qualification (C&Q) at the Interphex workshop yesterday was really power packed! With the knowledgable Dr. Alice Redmond and experienced Robert Steen and Joe Eades, we were fed with all the current practices of C&Q. Robert even gave clear examples on C&Q of compressed air and water.It seems that current practices of C&Q adopt the ASTM E2500-07 and ISPE CQ

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-75805464631229259022009-05-31T11:42:00.004+08:002009-05-31T12:00:00.103+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-62650703480338893172009-05-29T17:24:00.014+08:002009-05-30T00:00:57.742+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-9630736016259677482009-05-29T09:01:00.006+08:002009-05-29T09:51:35.950+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-22540242052455993052009-05-28T08:52:00.005+08:002009-05-28T08:57:36.188+08:00

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=guidesIt's free.... don't worry!

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-1343763019909119222009-05-27T13:25:00.004+08:002009-05-28T08:49:39.890+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-1542352755824572722009-05-27T13:20:00.003+08:002009-05-27T13:25:12.380+08:00

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!"

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-80869341493168989892009-05-23T19:58:00.007+08:002009-05-23T23:48:45.726+08:00

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,

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-82126035101158734672009-05-18T08:06:00.008+08:002009-05-18T08:36:55.710+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-28911537087778735382009-05-14T01:30:00.005+08:002009-05-14T01:48:30.653+08:00

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,

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-44056329718852257362009-05-10T05:21:00.006+08:002009-05-10T05:49:41.021+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-1182349259691713312009-05-09T04:40:00.013+08:002009-05-09T05:10:07.387+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-34331092024263993082009-05-08T04:58:00.005+08:002009-05-08T05:08:50.553+08:00

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.

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-71757031997057880232009-05-07T03:50:00.010+08:002009-05-07T11:24:01.777+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-39677506175918091762009-05-06T21:15:00.004+08:002009-05-06T21:22:47.046+08:00

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!

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com2tag:blogger.com,1999:blog-701394661394782861.post-24632942449333584422009-05-06T01:14:00.005+08:002009-05-06T01:48:01.175+08:00

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

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-1989645319946494922009-05-06T01:08:00.004+08:002009-05-06T01:13:51.045+08:00

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,

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com2tag:blogger.com,1999:blog-701394661394782861.post-76496818499917538542009-05-06T00:59:00.007+08:002009-05-06T02:05:33.677+08:00

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!

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-7611666531789769272009-04-27T19:31:00.009+08:002009-04-27T19:58:01.529+08:00

Just came back from Kuantan today after visiting IIUM Pilot Plant. Looks like its almost 'ready' for all equipment to come in.Key personnel has been interviewed and those suitable should be given the appointment letter soon. Congrats to those selected! These are indeed capable people who will serve the Pilot Plant and Kulliyah Phamacy well. How I wish I'm young enough to be part of this Pilot

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-27032741309201451922009-04-26T21:16:00.000+08:002009-04-26T22:47:49.063+08:00

It worry me to realise that many of our Malaysian manufacturers choose to ignore the risk we faced when many of their operation personnel are inadequately trained. The percentage is higher amongst the cosmetics and traditional/herbal product manufacturer, as compared to the pharma. Yes, most of us acknowledge the importance trainings play to ensure compliance to set procedures and GMP

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-58314797492445569562009-04-25T23:06:00.000+08:002009-04-25T23:28:15.698+08:00

This issue seems to trouble many new starters in GMP. Should the water purification be deionization (DI), or via reverse osmosis (RO)?The answer actually lies on the final output desired. The output quality must be able to achieve the desired specification for a Purified Water, usually in compliance to BP or USP. So, you can use either DI, or RO, or combination of both, as long as the final

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-6133015800866687122009-04-25T09:29:00.000+08:002009-04-25T09:38:19.944+08:00

Date: 31 May to 02 June 2009.Don't miss this opportunity to get yourself updated with the latest trend and practises in pharma industry. You get to hear from the experts, make contacts, and what I like most, is the chance to visit a well established pharma plant. You won't be able to walk into them unless you have good reasons!There are few exhibitors, but not comparable to Achema..! But it'll

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-70792383140858144152009-04-25T09:12:00.003+08:002009-05-07T12:26:39.789+08:00

ACHEMA 2009 is just round the corner. Frankfurt , Germany has been the main venue for this exhibition. I can say that this is the biggest exhibition of pharmaceutical machineries with the latest technologies being promoted to visitors. Other related materials are also exhibited. Glad that I'll be there from 11 to 14 May 2009. I have a FAT to conduct on behalf of IIUM, for a High Speed granulator

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0tag:blogger.com,1999:blog-701394661394782861.post-35073895546768420312009-04-25T08:07:00.000+08:002009-04-25T22:15:31.838+08:00

GMP requires new equipment be pre-inspected before delivery to processing site. This gives us opportunity to verfiy that the Design Specifications comply to our User Requirement Specifications (URS) and also an opportunity to travel!This FAT is for a tablet coater in Shanghai, China.Picture on right is us at Yang Garden.We then moved on to Shanghai river bank and admire the cherry blossoms.

Azman AJhttp://www.blogger.com/profile/13184370304184749903noreply@blogger.com0