GMP Audit, Consultation, and Inspection

FDA GMP refers to the Good Manufacturing Practice regulations set forth by the U.S. Food and Drug Administration (FDA). These regulations are a set of standards established and enforced to ensure that companies involved in the production and manufacturing of drugs, medical devices, and food adhere to specific quality standards and procedures.

FDA GMP encompasses a series of guidelines to ensure the safety, purity, and efficacy of products. These standards cover the entire production process from raw material procurement to final product delivery. The main principles include:
> Quality Management System: Ensuring the establishment and maintenance of a quality management system covering key processes such as production, documentation, review, and other critical processes.
> Personnel: Training and evaluating employees to ensure they have the appropriate skills and knowledge to perform relevant manufacturing tasks.
> Equipment: Ensuring the use of equipment suitable for its purpose, undergoing regular maintenance and calibration.
> Raw Materials: Ensuring high-quality raw materials are obtained from reliable suppliers and undergo appropriate testing and validation.
> Production Process Control: Ensuring effective control of the production process to prevent defects and ensure products meet specified standards.
> Inspection and Testing: Conducting necessary inspections and tests to ensure products meet prescribed quality standards.
> Records and Documentation: Maintaining appropriate records and documentation for tracing the manufacturing process of products.

Humphries can provide comprehensive cGMP (Current Good Manufacturing Practice) compliance audits tailored to clients' specific needs, including one-time initial audits and continuous audits. The company has an experienced audit team committed to providing valuable insights and feasible improvement suggestions following the principles of independence and impartiality. Audit activities cover various GMP areas, including formulations/APIs, excipients and raw materials, and GMP laboratories.