cGMP Manufacturing: What Does It Mean?
All products sold under the Puritan Products brand are manufactured in cGMP-compliant facilities registered with and successfully audited by the FDA.
We are compliant with 21 CFR Parts 210 and 211.
- Part 210 of the Code of Federal Regulations encompasses current Good Manufacturing Practices in manufacturing, processing, packing or holding of drugs from a general perspective
- Part 211 provides the regulations for good manufacturing practice for finished pharmaceuticals
We also follow the 10 Key Principles of Current Good Manufacturing Practices, which include:
- Writing step-by-step procedures that provide a roadmap for controlled and consistent performance.
- Carefully following written procedures to prevent contamination, mix-ups, and errors.
- Promptly and accurately documenting work for compliance and traceability.
- Proving that systems do what they are designed to do by validating work.
- Integrating productivity, product quality, and employee safety into the design and construction of facilities.
- Properly maintaining facilities and equipment.
- Clearly defining, developing and demonstrating job competence.
- Protecting products against contamination by making cleanliness a daily habit.
- Building quality into products by systematically controlling components and product related processes.
- Conducting internal planned and periodic audits.
Learn more about Avantor’s cGMP manufacturing.