Pharmaceutical Excipient GMP

  • Overview
  • Benefits
  • Why Work With NSF?
  • Certification Process

NSF/ANSI Standard 363: Good Manufacturing Practices for Pharmaceutical Excipients provides assurance to excipient manufacturers that the products they are selling to pharmaceutical companies have been manufactured in a facility with the necessary quality system requirements.

Benefits

NSF/ANSI Standard 363: Good Manufacturing Practices for Pharmaceutical Excipients provides multiple benefits including:

  • Increased creditability and competitive advantage in the marketplace for pharmaceutical excipient manufacturers
  • Decreased number of audits by pharmaceutical manufacturers in qualifying pharmaceutical excipient manufacturers as a part of their vendor qualification process 
  • Decreased time and cost for pharmaceutical manufacturers in selecting quality vendors of excipients for use in the manufacture of over-the-counter and prescription pharmaceutical products
  • Demonstrated independent third-party verification of continuing conformance to GMPs
  • Availability to all manufacturers of excipients

Why Work With NSF?

NSF/ANSI Standard 363: Good Manufacturing Practices (GMPs) for Pharmaceutical Excipients demonstrates that manufacturers were independently screened by NSF as complying with GMP requirements listed in IPEC/PQG along with the quality system requirements in ISO 9001.

Our expert consultants can assess the state of GMP compliance of pharmaceutical excipient manufacturers. Vendor qualification audits based on a standardized auditing and grading approach can help to assure your company provides safe products to customers and reduce the likelihood of having to remove product from shelves due to a recall.

Certification Process

NSF/ANSI Standard 363: Good Manufacturing Practices (GMPs) for Pharmaceutical Excipients focuses on quality management and provides pharmaceutical companies purchasing excipients from manufacturers throughout the world a means to qualify their vendors and suppliers.

The process involves manufacturing facility audits to ensure excipients are manufactured in a standard way and that employees follow set procedures in recordkeeping, personnel qualifications, sanitation and cleanliness, and equipment maintenance.

Related to Pharmaceutical Excipient GMP

See all related news

See all training

Pharma / Biotech Mailing List

Health Sciences Newsletter

View Mailing List Archives

close