A pharmaceuticals manufacturing compliance checklist for US companies
The FDA has thousands of published guidance statements. Here are just a few:
- Good Laboratory Practice Regulations
- Bar Code Label Requirements
- Contract Manufacturing Arrangements for Drugs
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
- Drug Master Files: Guidelines
- How to Comply with the Pediatric Research Equity Act
- Consumer Antiseptic Wash Final Rule
FDA compliance requirements are based on CGMP (Current Good Manufacturing Practices). The FDA wants strong quality systems, use of quality materials, robust manufacturing practices, and good standard practices.
We put these together to prevent instances of contamination, mix-ups, deviations, failures, and errors. The “c” stands for current so we must continue to improve and use best practices, not rely on existing processes or systems to carry us through.
The FDA can audit pharmaceutical companies to verify they are using CGMP at all times. If they find a violation or shortfall, they can force repairs and changes to a company’s practices. They can also file criminal charges if the situation warrants.
Each pharmaceutical business is responsible to find and understand which of the thousands of requirements apply to their particular business. Next, the business develops CGMP following FDA guidelines but uniquely tailored to their business and the processes that make sense for them.
Manufacturing Process Instructions
Manufacturing Process Instructions (MPI) are a key component to any pharmaceutical compliance plan. Systematically, exactly how does manufacturing combine ingredients to yield the product that will ensure the patient’s health with little or no risk of adverse reactions?
The process must yield the necessary strength and potency. If there are grades of potency at the end, the MPI should document where the grades can be used.
Test and Measurement
Test and Measurement (TM) is another part of CGMP. What measurements are needed? How often should the test instrument be calibrated? What parameters define pass and fail? ERP contains the required equipment and the limits of testing are part of ERP quality systems.
Standard Operating Practices
Standard Operating Practices (SOP) are defined to ensure that people throughout the organization have common, documented, procedures. The use of ERP systems is part of the SOP documents,
The business should develop internal audit processes to check that all follow the guidelines and that all processes have documented guidelines.
Drug Master Files
Drug Master Files are submissions to FDA that confidentially provide facilities, processes, materials, and articles used to manufacture package, and store human drugs. This data comes directly from ERP.
The manufacturing process flow and the ingredients are all ERP components. Storage considerations will be shown as stockroom qualities such as a limited temperature range.
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