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MEETING THE LATEST REGULATORY GMP REQUIREMENTS DURING CLINICAL MANUFACTURING, UNDERSTANDING KEY DIFFERENCES IN IMPLEMENTING GMPS IN CLINICAL VS. COMMERCIAL MANUFACTURING

August 19, 2020 | (10.30AM)
USA (United States of America)
SHARESHARESHARE
While operating your commercial manufacturing according the GMP's can be difficult, adhering to the regulations during manufacture of materials destined for clinical trials poses even more challenges. Unlike commercial operations where operations are well defined and processes are validated, clinical manufacturing processes are in a constant flux. In the same way your testing is also evolving as the knowledge of your product and processes increases. How can we maintain GMP's in this evolving world of constant change? It is a challenge that many companies face and have difficulty with. It requires the manufacturing organisation to retain flexibility and agility of operation, but it requires more from the Quality organisation. These staff must retain appropriate levels of control where needed, yet exhibit flexibility when required. Does that mean that GMP's do not apply or we administer GMP-lite? No. Rather we tailor the GMP's to meet the challenges of the special circumstances of the operations. In some cases, we allow great flexibility and in others we enforce tighter controls. Because everything is in flux, we can not build quality into operations and must rely on testing quality in - a cardinal sin in commercial operations. In clinical manufacturing the overall target is to protect the patient in a world of absence of concrete knowledge, especially when not knowing if the product even works.