End of last Year gemro was hired by a customer to do an intensive GMP gap analysis for Beijing Yiling Pharmaceutical Group’s new production facility. Yiling Pharmaceutical Group is offering contract manufacturing services for the production of solid dosage forms in his newly erected facility.

The contract was made at the end of 2009. Execution of the gap analysis took place in January 2010. The project has to be fulfilled in a very short time because Yiling Pharmaceutical Group was facing an official inspection by the UK’s MHRA (Medicines and Healthcare products Regulatory Agency) early this year.

Based on our service package procedure gemro started immediately gathering some relevant information of this new production site to prepare for the intensive gap analysis. Also a special checklist was sent out to the head of the quality department to ask for some more details and to analyze in a first step on what the situation is with view to western GMP requirements. In this case a western expert was involved to go onsite for altogether 2 days. The gap analysis was done similar to a real GMP compliance audit but with much more onsite consultancy and explanation on the individual “how to dos”. Also the final gap analysis report was prepared the same way, not only showing the gaps and classifying the gaps but also giving detailed ideas on how to improve and how to fit the gaps.

Based on these results Yiling Pharmaceutical Group could improve their situation in short time and also were well trained for this upcoming official inspection. The MHRA inspection was well passed with only minor complaints and so far Yiling Pharmaceutical Group can be classified as a contract manufacturer for final dosage form preparations complying with western GMP standards.

If you want to learn more about our service packages, please contact Cobby Zhang on c-zhang@gemro-services.com or on phone: +86 20 8736 5457.

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