Quality Assurance Needs to be the Watchword in the cGMP Manufacturing Lab


Through it we hope to share with you our thoughts, expertise and insights into the fast-changing world of biopharma, life sciences and the contract research organizations (CROs) and contract manufacturing organizations (CMOs).  And we hope that’s only the beginning of the conversation.  We look forward to hearing from you as well, hearing your thoughts on our posts and learning from each other as we navigate this dynamic landscape.

One of the key trends driving the industry is a focus on quality control, yet aside from required regulatory mandates, that can mean different things to different organizations.  One of our core pillars is an unwavering commitment to ensuring quality in everything we do – from cleanroom operations, to calibration of instruments and preventative maintenance in utilities systems, and we’ve built processes and controls that help us meet our own strict standards, as well as industry regulations.  We maintain cGMP quality systems compliant with ICH Q7, and our class 100,000 finishing and packaging areas ensure high quality manufacturing for all our APIs and drug substance products.

In a six-part series of blogs, PCI Synthesis will provide a “behind-the-scenes” look at specific processes and controls we have put in place in core quality control areas in the lab. We hope you find it to be useful information and we look forward to hearing of other ways quality is ensured in your organization.     

Ed Price, President, PCI Synthesis