The quality of the medicines, cosmetics, vaccines, biologics and other products produced by a Company, throughout the entire process, from the post-marketing, pre-clinical and clinical phases is paramount to its success.
Regulatory Agencies have zero tolerance to product defects as a result of poor quality. The expectation is for products to reach the highest standards of purity and conformance to specification. This requires accurate and thorough testing of all materials used to produce the final finished form of the product.
During the clinical trial phase, the final ‘post-marketing production batch size’ may not have been finalised. The scaling up of the batch sizes can potentially result in quality issues. The processes involved have to be considered and documented fully in terms of what was done to test the stability of the product quality during production, no matter what the batch size.
PharSafer® partners with experienced GMP and GLP Companies in this area. They all have the key experience and audit skills for potential Regulatory Inspections, meaning that they can carry out audits of manufacturing sites to ensure they are suitable and prepared for a Regulatory Inspection.