In the United States, Current Good Manufacturing Practices, or cGMPs, are the FDA‘s formal regulations contained in statutes and agency policies and concern the design, monitoring and control of manufacturing processes and facilities. The addition of “current” reminds manufacturers that they must employ current technologies and systems in order to be in compliance with the regulations. An FDA inspection of a pharmaceutical manufacturing facility includes an evaluation of whether the facility is following the cGMP regulations and operating under a cGMP quality system. Inspections may be random or may be triggered by adverse events reports from the public or industry.
If following an FDA inspection, a manufacturer is found non-compliant with the cGMP regulations, the FDA will issue a Form 483 to which the company must respond with an explanation, or if required, steps for corrective action. “This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors,” according to the FDA.
Robert P. Mino has led a team that has created a cGMP quality system. The quality system was audited and obtained ISO 17025 accreditation for analytical chemistry testing services, audited by medical device and other clients, and provided a high-quality program from sample to data. He has also drafted FDA 483 responses, reviewed dozens of quality-related contracts, and had had experience working with state regulatory agencies. He understands quality system needs and has retained a team of top quality individuals to assist, if necessary, on any component of the drafting. If you or your firm is seeking help on building a quality system, please call Robert P. Mino, PA, today for consulting help with your quality system SOPs, QMS, mock audits, or other needs. With experience and connections to a stable of world-class talent, we can compete with the rest and provide the very best. Click here to learn more.