Summary of APIs

Short description of Apis


8/26/20231 min read

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.