One of the key responsibilities of pharmaceutical manufacturers is to test the materials used in the manufacturing process to ensure safety and compliance and keep production running smoothly. At SAXOCON, we have the in-house expertise and experience to help you quickly assess and test your production components and materials.
One of the greatest risks manufacturers of pharmaceuticals face is that a product gets contaminated during the manufacturing process. Such an incident can stop production until the contamination source is located and eliminated or, in the worst-case scenario, result in a product recall.
Contamination in pharmaceutical production can occur at every stage of the production process, from sourcing materials to processing the materials to filling the final drug product. Pharmaceutical manufacturers and CDMO facilities can contain thousands of components and materials that can come into contact with the drug products being produced (PCMs).
Good Manufacturing Practice (GMP) provides no guidance on what or how to test PCMs. This is where the BioPhorum Operation Group (BPOG) recommendations and the United States Pharmacopeia – National Formulary (USP) guidelines can help. The BPOG recommendations and USP chapters 665 and 1665 provide guidance about what to test and how to test it. Proper testing and a transparent supply chain with fully identified materials can help reduce the number of unexpected findings and ensure your products are safe, reliable, and compliant.
Check out our services to see how we can help you:
Equipment Safety
Cleaning Validation
Unexpected Findings
Imupurities Testing