Pharmaceutical Manufacturing involves the manufacture of APIs into a product in a GMP environment. Pharmaceutical manufacturing can involve complex systems which require regular in-process analysis, inspection, testing, document control, data collection, and may require quality investigations.
Maintaining and documenting detailed and accurate policies, procedures, results, and work instructions, according to specified regulations, is important in maintaining a process that is compliant, and meets customer requirements. The batch review process is essential to ensure the quality of your product and in meeting customer and regulatory requirements. Incorrect records or processes can lead to out-of-spec products and nonconformances during the audit process.
Quality As You See It has the experience and knowledge in pharmaceutical manufacturing to support your in-process activities, document control, batch recorded review, and quality investigations.