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 is 20 cfu/ml, or more....?
Thus, a sample size of 1ml using pour plate method will neatly fit this situation. Most samples o Purified Water will be more than 10 cfu/ml and this will show well on the agar plate.
However, if you consistently achieved a level of less than or equal to 1 cfu/ml, then you should adopt the new method using microbial filtration and sample size of 100ml.
Anyone out here having problems with microbial test on Purified water that you can share..?
We'd like to hear form you!
AJ
Saturday, July 25, 2009
GMP Consultant = Consultant Engineer ?
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 (size and materials), exact X-Y positions of the drain holes and presented in an auto-cad drawing with scale 1:200!
If I'm able to do all these, I might as well assume the position of an M&E consultant and charge a higher fee !
Actually, GMP Consultants provide only the conceptual design of the facilities and utilities, whereas the Consultant Engineers provide technical and engineering input. For example, a GMP consultant provide the HVAC requirements specifications, but the engineers will calculate and size the required equipments and provide the technical drawings for construction.
Yes, that's how we can work as a better team..!
Got it...??
AJ
Seems this is not enough.... They want me to provide the draine slopes, the pipe details (size and materials), exact X-Y positions of the drain holes and presented in an auto-cad drawing with scale 1:200!
If I'm able to do all these, I might as well assume the position of an M&E consultant and charge a higher fee !
Actually, GMP Consultants provide only the conceptual design of the facilities and utilities, whereas the Consultant Engineers provide technical and engineering input. For example, a GMP consultant provide the HVAC requirements specifications, but the engineers will calculate and size the required equipments and provide the technical drawings for construction.
Yes, that's how we can work as a better team..!
Got it...??
AJ
Anyone dumb for a chocolate..?
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...!
Lecture at new Kulliyah Pharmacy, IIUM
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 sharing with the Medicine faculty all this while, and having one will means a higher number of students intake from now on.
Well... being new, many things are still in a mess. Lecture halls are spacious and grand, but computers was not equipped with a monitor for lecturer to see. I had to turn my head to view what's on the screen. Thank God my lecture was only for 2 hours. Anything more will land me with a neck sprain.!
I know Dr Mohamad Awang is doing his best to get all this sorted out.
One good outcome to the inhabitants of this Kulliyah Pharmacy (as what I heard...) from this event is that many have managed to slim down to a perfect figure..!
AJ.
Sunday, July 12, 2009
Registration of Veterinary medicine
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 the submission process.
However, don't despair... You are still able to submit these products after the dateline. The only difference is you will not be able to enjoy the privilege given to those submitted before the dateline.
Those products will obtain the status as "Existing product" and can continue to be in the market while their submission undergo evaluation.
Non-existing product cannot be in the market until approved by DCA. If found to do so, you may be found guilty and have to pay a penalty for this.
Got it...?
AJ
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 the submission process.
However, don't despair... You are still able to submit these products after the dateline. The only difference is you will not be able to enjoy the privilege given to those submitted before the dateline.
Those products will obtain the status as "Existing product" and can continue to be in the market while their submission undergo evaluation.
Non-existing product cannot be in the market until approved by DCA. If found to do so, you may be found guilty and have to pay a penalty for this.
Got it...?
AJ
Sunday, July 5, 2009
Vet, oh vet.........
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 followed by vet manufacturer is still the same PIC/S GMP guidance, Annex 4 of the guidance allows some leniency in the facility design. For instance, vet manufacturers are allowed to manufacture beta-lactam products in the same facility as other products, provided it is done on a campaign basis and efforts taken to ensure effective removal of any beta-lactam residues before the change over to another product.
Annex 4 also allows manufacture of sterile products be done in a lower grade than human sterile medicines, but not lower than Grade D. Well...... that's fair enough.
However, I am still amazed with the requirements to fully comply with the pharma standards for water system....... Yes, we may comply to this, but just give a second thought on what the animals eat or drink after consuming these 'high standard' medicines...? Yes, they go back to the usual hay, or feed, etc, all from the usual receptacles, and may drink from a trough, river or pond.... That sure has much higher level of impurities and microbes!
Just give that second thought.....
AJ.
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 followed by vet manufacturer is still the same PIC/S GMP guidance, Annex 4 of the guidance allows some leniency in the facility design. For instance, vet manufacturers are allowed to manufacture beta-lactam products in the same facility as other products, provided it is done on a campaign basis and efforts taken to ensure effective removal of any beta-lactam residues before the change over to another product.
Annex 4 also allows manufacture of sterile products be done in a lower grade than human sterile medicines, but not lower than Grade D. Well...... that's fair enough.
However, I am still amazed with the requirements to fully comply with the pharma standards for water system....... Yes, we may comply to this, but just give a second thought on what the animals eat or drink after consuming these 'high standard' medicines...? Yes, they go back to the usual hay, or feed, etc, all from the usual receptacles, and may drink from a trough, river or pond.... That sure has much higher level of impurities and microbes!
Just give that second thought.....
AJ.
Labels for Health Supplements
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, graphics definitely differ, and all these will impose high restrictions in designing of the product labels.
Such restrictions may be good for the medicinal drugs, but for health supplements...???
I am surprised that the industries have no objection to this ruling. I forsee tremendous havoc with registration of imported products. Well, let's see how it goes.....
AJ.
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