Summary of APIs

A Summary related to pharmaceutical APIs manufacturing and packaging are:

● Introduction to APIs and their role in drug development and production

● Quality management and good manufacturing practices (GMP) for APIs

● Personnel qualifications, hygiene, and training for API manufacturing

● Design and construction of buildings and facilities for API production

● Process equipment selection, maintenance, cleaning, and calibration

● Documentation and records management for API manufacturing

● Materials management, including receipt, quarantine, sampling, testing, storage, and re-evaluation of raw materials, intermediates, and APIs

● Production and in-process controls, including time limits, sampling, blending, and contamination control

● Packaging and identification labeling of APIs and intermediates, including packaging materials, label issuance and control, and packaging and labeling operations

● Storage and distribution of APIs and intermediates, including warehousing and distribution procedures

● Laboratory controls, including testing of intermediates and APIs, validation of analytical procedures, certificates of analysis, stability monitoring, expiry and retest dating, and reserve/retention samples

● Validation of API manufacturing processes, including validation policy, documentation, qualification, approaches, program, and periodic review

● Change control for API manufacturing processes

● Rejection and reuse of materials in API manufacturing

● Complaints and recalls of APIs and intermediates

● Contract manufacturers and laboratories for API production

● Agents, brokers, traders, distributors, replacers, and relabels of APIs and intermediates

● Specific guidance for APIs manufactured by cell culture/fermentation

● APIs for use in clinical training.