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 should you when you know that you have all in place...?
Important things to do is to check that your facility and equipment are in order with no severe defects. Ensure that documents and records are up to date and in order. Ensure that materials/products in warehouse and in production areas are well segregated, identified and protected. Hygience and cleanliness taken care of. Training of staff done as per training program. Self audit done, recorded and corrective actions taken. And many other routine things.....
A self audit will definitely helps in probing and uncovering any 'unturned stones'. This is best done by person not from that department, and better from outside the facility. Such person will have a look at your facility from a different angle and without bias. I am not promoting that you enagage us as an external auditors, but those who have done so did benefit from this service. Those in the facility are used to see 'non-compliance' happening right in front of their eyes and yet 'believing' it to be okay..... it's just like a normal thing.... they become 'immune' (if you know what I mean...)
However, external auditors can easily see such 'non-compliances'. Coupled with their experience at other facilities, such non-complaince can be easily spotted and proposed corrective actions can also be extended by these external auditors.
Whatever it is, always planned for a GMP audit and do not be taken by surprise. If you can have a well organized plan in case of fire, why not have one for a GMP audit....?
Good luck!
AJ.
Thursday, September 10, 2009
Sunday, September 6, 2009
Facility qualification of a new manufacturing plant
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 'qualification' needs between Good Engineering Practise (GEP) and GMP and highlighting it to the appointed contractor/supplier. The documentation needs and focus required by GMP is different from GEP. While GEP focus on the capability and safety of the facility, GMP focus more on the performance and ability to maintain product integrity and quality. Some (if not most) of the activities overlap. A well prepared qualification plan will cunningly make use of what's done under GEP to incorporate into qualification as required by GMP.
The recent ISPE conference in Singapore highlighted this matter in their pre-conference workshop and even provide examples on how this can be effectively done. To me, this is logic which should have been adopted much earlier if not for the 'narrow mindness' of some practitioner that GEP is a total separation from GMP.
Having said all that, the qualification of facility is still laborious and time consuming. The delay in initiating this effor, concurrent with the commission done by suppleir, will further aggravate the problem one have to face.
How I wish this qualification job was 'given' earlier to me as their GMP consultant, rather than entrusting it to the supplier....... but how can I reject...?
AJ.
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 'qualification' needs between Good Engineering Practise (GEP) and GMP and highlighting it to the appointed contractor/supplier. The documentation needs and focus required by GMP is different from GEP. While GEP focus on the capability and safety of the facility, GMP focus more on the performance and ability to maintain product integrity and quality. Some (if not most) of the activities overlap. A well prepared qualification plan will cunningly make use of what's done under GEP to incorporate into qualification as required by GMP.
The recent ISPE conference in Singapore highlighted this matter in their pre-conference workshop and even provide examples on how this can be effectively done. To me, this is logic which should have been adopted much earlier if not for the 'narrow mindness' of some practitioner that GEP is a total separation from GMP.
Having said all that, the qualification of facility is still laborious and time consuming. The delay in initiating this effor, concurrent with the commission done by suppleir, will further aggravate the problem one have to face.
How I wish this qualification job was 'given' earlier to me as their GMP consultant, rather than entrusting it to the supplier....... but how can I reject...?
AJ.
Friday, August 21, 2009
Kotra Pharma's new facility
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 Kotra Pharma's existing plant. Already a big one.....
Now you only see 50% of the building
.
This is their new plant. Still under construction. This is only the front view... The facility looks 4 times bigger from side.
Wish all the best to staff and management of Kotra Pharma Sdn Bhd.
AJ.
Monday, August 17, 2009
Qualification required for secondary packager
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 Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
=(
AJ.
Water used for final rinsing of contact parts must also be of Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
=(
AJ.
Saturday, August 8, 2009
Cosmetic notification wih DCA
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 of the paymasters are not the same person entering these data into Quest2. So, why bother....? At least, some people will be kept occupied re-entering the notification data.
AJ.
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 of the paymasters are not the same person entering these data into Quest2. So, why bother....? At least, some people will be kept occupied re-entering the notification data.
AJ.
Saturday, July 25, 2009
Lab Asia 2009
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.html
And block your diary to ensure you do not miss this golden oppotunity.
HVAC qualification by supplier/contractor
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 GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.
However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.
The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?
Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.
AJ.
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 GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.
However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.
The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?
Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.
AJ.
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