The role of quality and compliance and how PLG can support your needs

Safety and efficacy are two of the more critical themes throughout the entire lifecycle of a medicinal product. During product development, pre-clinical studies look at toxicity and lethal dosages of medicines. In contrast, during clinical studies, a log of side effects is kept in the drug safety master file (DSMF). Pharmacovigilance is an entire discipline dedicated to tracking safety and efficacy concerns during the product’s registration and post-approval. But what about the manufacturing of the product? This is where the regulations for quality and compliance (Q&C) come to the fore.

Product compliance means that medicinal companies always obey all applicable regulatory requirements. Medicinal companies must manufacture according to Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), and other relevant regulations.

At PLG, we recognize that pharmaceutical Q&C has several disciplines within it, and it can be arduous to set up a manufacturing facility following the evolution of regulations, create systems for the safe and effective manufacturing of these medicines, and keep updated as regulations change for improvement.