Apart from general regulatory requirements and recommendations that apply to all drug manufacturing guidelines, including the Code of Federal Regulations and ICH (Q7A) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, there is only one guideline specifically dedicated to peptides, which makes it all the more easy to follow. Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances, issued in 1994, stipulates that the lot-release specifications—a set of tests and acceptance criteria that must be met before a product is released—must be sufficient to ensure the identity, purity, strength, and potency of the peptide and to demonstrate lot-to-lot consistency.
Of course, every product manufactured under current good manufacturing practices (cGMPs) must undergo a battery of analytical tests. Each batch should be provided with a lot-specific certificate of analysis (CoA) documenting specifications, test methods, and results. A typical CoA contains information on appearance, solubility, purity by gradient HPLC, molecular weight, as well as peptide counter ion, water, and residual organic solvent content.Bearing all these elements in mind in a holistic fashion is critical for implementing a sound quality system. Indeed, the key word for any effective approach to quality outcomes is system. Given that every component of a manufacturing process contributes to the quality of the final product, without a comprehensive systems approach to the entire process, even a minor misstep could compromise final outcomes.
A quality system in a pharmaceutical manufacturing environment comprises several components, including, but not always limited to, facilities and equipment, laboratory controls, materials, packaging, and labeling. These components should be designed to incorporate redundancies and fail-safes, because failure of one component can mean failure of the entire operation.
Overall, a focus on quality must have regulatory compliance as its ultimate goal. Adherence to cGMPs, coupled with a robust documentation program, can ensure reproducible and verifiable quality procedures. A comprehensive systems approach that takes into account every miniscule aspect of the manufacturing operation—from documentation to capital equipment—is the surest way to guarantee final quality of your product.
Shawn Shirzadi is the vice president of quality at American Peptide Company Headquarters, Sunnyvale, CA, 408.733.7604, [email protected]