Industry news

Global Protocol to Assess OTC Pharmaceuticals and Prescription Drug Manufacturers’ Compliance with GMP

NSF International, through its subsidiary NSF-DBA, has developed a new global protocol to assess whether an over-the-counter (OTC) pharmaceutical or prescription drug manufacturer complies with current Good Manufacturing Practices (cGMPs) as outlined in the Code of Federal Regulations (21 CFR 210 & 211).

The quality and safety of OTC products is highly dependent upon the conditions in which they are manufactured. For many years, the FDA has considered the OTC sector as ‘lower risk’ and has not had the resources to routinely inspect all OTC manufacturers. Recent high-profile enforcement activities have, however, resulted in significant issues and FDA warning letters for OTC manufacturers.

The new protocol, titled NSF P414-201x, Auditing Practices for the Assessment of the Manufacture of Over the Counter Drugs against Established GMP Standards, helps manufacturers understand which requirements must be met in order to produce OTC drugs, including pain relievers, nasal decongestant sprays, cough syrups, antacids and allergy medications. The protocol outlines requirements for personnel, building and facility maintenance, equipment, production/process controls, holding/distribution, laboratory controls, recordkeeping and packaging and labeling.

Regulators and industry representatives, including the USA’s largest drugstore chain, Walgreens, have championed the development of the NSF protocol. The OTC and prescription drug protocol is intended to be developed into an NSF American National Standard for OTC and prescription pharmaceuticals by NSF International, an independent organization that writes standards, and tests and certifies products for the food, water, nutritional, health and wellness industries, as well as consumer goods. NSF is currently forming a Joint Committee to develop the protocol.

“Customers and patients need to have complete trust in the safety of all medicine, whether prescription or over-the-counter,” said Alain Turenne, director, product integrity, at Walgreen Co. “If there are industry gaps of any kind in monitoring, standard setting and quality control, we need to fill them. We are proud to be working with NSF International to continuously elevate our already strong standards for product safety and integrity.”

The new NSF regulatory-based protocol focuses on quality management and provides companies outsourcing manufacturing of drug products, including pharmacy retailers and others, with a means to qualify their pharmaceutical vendors and suppliers. Using a standardized auditing approach, the protocol establishes a grading scheme to ensure OTC manufacturers meet global GMP drug requirements through the inclusion of principles and guidance from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as well as 21 CFR 210 & 211.

“The new NSF protocol for over-the-counter and prescription drugs builds on NSF’s significant expertise in pharmaceuticals and dietary supplements and furthers our mission to protect public health,” said Casey Coy of NSF-DBA. “Vendor qualification is a crucial component for pharmacy retailers to ensure they receive high quality OTC and prescription drugs from their vendors and avoid potential recalls. The significant costs involved in a product recall are not only absorbed by the drug manufacturer but the retailer as well.”

Since its founding in 1944, NSF International has developed nearly 80 public health and safety standards. These include the American National Standards for foodservice equipment used in restaurants as well as the American National Standards for products coming in contact with drinking water (including water filtration units) which were adopted by the U.S. Environmental Protection Agency (EPA). NSF also developed the American National Standard for dietary supplements (NSF/ANSI Standard 173) and tests supplements to that standard to ensure there are no undeclared ingredients or unsafe levels of contaminants and verify that manufacturers comply with GMPs.