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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:

  1. Writing step-by-step procedures that provide a roadmap for controlled and consistent performance.
  2. Carefully following written procedures to prevent contamination, mix-ups, and errors.
  3. Promptly and accurately documenting work for compliance and traceability.
  4. Proving that systems do what they are designed to do by validating work.
  5. Integrating productivity, product quality, and employee safety into the design and construction of facilities.
  6. Properly maintaining facilities and equipment.
  7. Clearly defining, developing and demonstrating job competence.
  8. Protecting products against contamination by making cleanliness a daily habit.
  9. Building quality into products by systematically controlling components and product related processes.
  10. Conducting internal planned and periodic audits.

Learn more about Avantor’s cGMP manufacturing.