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 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.
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. =(
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 You will not be punished, but your submission will be withdrawn or rejected.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.
Thank you for coming to my blog. I feel that GMP issues should be bravely discussed and openly highlighted to enable us to fine tune our practise and make them better and better. Let's not be selfish. Come share our knowledge and experience in this area where there are many possibilities of doing the right thing to meet the same required standard of GMP. Please feel free to comment and email me on GMP relevant issues. I know there are many experienced and knowledgeable people out there.