Current Good Manufacturing Practices

cGMPs are a set of best practices outlined by the US Food and Drug Administration to ensure that pharmaceutical and biotechnology products meet specific requirements for identity, purity, potency and stability. cGMP regulations are more rigorously applied as products move forward in development. For products manufactured for Phase I studies, all the regulations apply, although in a somewhat less detailed manner. By the time a product reaches Phase III Clinical trials, cGMPs are expected to be fully followed. All of our manufacturing processes are designed to be in accordance with cGMP regulations.

Important components of cGMPs are:

• The use of a dedicated, clean manufacturing facility
• Having a properly trained staff
• Validating your facility, equipment, materials, and manufacturing processes
• Following written standard operating procedures (SOPs) for all aspects of production and facility operation
• Testing critical reagents, intermediates and finished products for identity, purity, potency and stability
• Keeping track of critical materials used during production
• Documenting how things have been done (through validation records, training records and product batch records)
• Implementing a Quality Assurance program (for document control, auditing and deviation reporting - with follow-up corrective and preventative action)