cGMP Manufacturing

Puritan Products is a cGMP compliant company which is also registered with the FDA and successfully audited by the FDA. This means we are compliant with 21 CFR Parts 210 and 211. Part 210 of the Code of Federal Regulations encompasses current Good Manufacturing Practice in manufacturing, processing, packing, or holding of drugs from a general perspective. Part 211 provides the regulations for good manufacturing practice for finished pharmaceuticals.

cGMP Manufacturing refers to the Good Manufacturing Practice Regulations decreed by the US Food and Drug Administration which is under the authority of the Federal Food, Drug, and Cosmetic Act. GMP regulations, which are enforced by law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. cGMP is a quality system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks to the general public of any pharmaceutical production that cannot be eliminated through testing the final product. Failure of companies to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Step-by-step procedures must be written to enable controlled and consistent performance. GMP requires documented proof that correct procedures are consistently followed at each step in the manufacturing process. The GMP requirements are generally open to interpretation which allows each manufacturer to decide how to best implement the necessary controls. The manufacturer must interpret the requirements in a way which makes sense for their business.

You will often see GMP written as cGMP. The “c” stands for “current,” meaning that manufacturers must use technologies and systems which are current in order to comply with the regulation. For example, a 15 year old piece of equipment used to prevent contamination may be inadequate by present day standards.

What does this mean to you?

  • Peace of Mind: Documented, traceable processes, supply chain security, management of change (MOC) with notification, and flexible risk mitigation planning.
  • Understanding your needs: The experience in manufacturing the products you need for your critical applications with all of the necessary documentation and traceability.
  • Proven: Our quality systems have been proven time and again with a 100% successful audit rate by many of the top Fortune 500 pharmaceutical companies as well as by the FDA. These audits help us keep up with industry needs and facilitate continuous improvements.
  • Service: Responsive, Reliable, Flexible
  • Analysis: Analytical capabilities in concert with our quality management systems to ensure your products are consistent from lot-to-lot and year-to-year.
  • Confidence: Full regulatory compliance. Each and every one of our employees receives detailed annual training on cGMP. In business for over 28 years, our processes have been challenged by some of the world’s largest companies and our confidence comes from knowing that we have consistently met or exceeded their demanding requirements.

We encourage you to review our comprehensive Quality Overview, designed as a self-audit, prepared by our Director of Quality using questions routinely received from customer and regulatory agent audits. This audit will provide you with a glimpse into our Quality Management System and answer many of your questions—from both an ISO and GMP perspective.

We also follow the 10 Key Principles of Current Good Manufacturing Practices.

  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.

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