Summary of APIs
Short description 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.