Knowhow-Now Article

GMP Audit And Pharmaceutical Contract Manufacturing Organizations

By Preetam Singh

Preetam Singh

A GMP Audit is an important event for those in pharmaceutical manufacturing industry. Traditionally pharmaceutical contract manufacturing organizations were chosen for cost efficiencies and to decrease the time-to-market. CMOs were thus involved in offering labor, equipment and specific technologies. The economies of countries like India and China are growing to sizable proportions.


Benefits of pharmaceutical contract manufacturing are the only reason behind this growth. It is by large gaining more importance these days, especially after year recession. Besides the traditional benefits companies are now outsourcing to contract manufacturing organizations to concentrate on marketing and business development. Seen once as a strategy adopted mostly by European and US-based multi-national companies, Pharmaceutical Contract Manufacturing is increasingly being adopted by all level of companies, for its obvious benefits.

It has always been essential to ensure the quality and compliance of suppliers providing GMP audit. Companies look for GMP certified manufacturers who can offer quality, in the most efficient timeframes. There is a need for quality testing, storage of APIs, drug products, excepients & packing materials. In effect, both quality and commercial criteria dictate the choice of vendors.

as always, you need to think about everything

In order to get maximum leverage of Contract Manufacturing, it is mandatory to focus on critical business issues; How to decide if a contract manufacturer has desired qualifications. How to ensure that we can have best manufacturers. Who can scrutinize this. And what should this auditor-auditing team look for.

With the level of contract manufacturing increasing, GMP Audit of CMOs is now becoming critical for pharmaceutical manufacturing companies. Technical details are not the only pre-requisite for Pharmaceutical Contract manufacturing arrangements, the commercial details are very often critical. What is a good agreement. – Certainly one that meets requirements of both the parties to make a cohesive association. Clearly, we need to be trained on how to make and sustain a good agreement. Once GMP manufacturing audit is done, is it viable enough to last for the whole tenure of the association-agreement.

It would be ideal to have the GMP audit repeated periodically. If an expertise auditor is not available in-house, one looks for external auditors. How to choose an auditor in such cases and what should be the criteria of choosing one and making an agreement for the same.

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It would be ideal to have the GMP audit repeated periodically. If an expertise auditor is not available in-house, one looks for external auditors.

make sure your supplier is up to the task

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