NSF International Develops Protocol to Assess Over-the-Counter (OTC) Pharmaceuticals and Prescription Drug Manufacturers’ Compliance with Good Manufacturing Practices

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Walgreens supports the development of new NSF protocol to standardize practices for OTC and prescription drugs.

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"We are proud to be working with NSF International to continuously elevate our already strong standards for product safety and integrity,” said Alain Turenne, director, product integrity, at Walgreen Co.

NSF International, a global independent organization that develops public health standards and protocols, and provides auditing, training and certification for the pharmaceutical, medical device and dietary supplement industries, 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).

GMPs establish requirements for the methods, facilities and controls used in the manufacturing, processing and packaging of a pharmaceutical product to make sure it is safe for use and contains the ingredients and strength it claims to have. The U.S. Food and Drug Administration (FDA) enforces the quality of pharmaceutical products by monitoring manufacturers' compliance with GMP regulations. 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 nation’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 International’s pharmaceutical consulting arm 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.

About NSF International's Health Sciences Division: This growing division offers training and education, consulting, GMP and GLP testing, certification, R&D, auditing and regulatory guidance for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle. The NSF Health Sciences Division includes: NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement and medical devices training expertise; NSF Pharmalytica, a GLP & GMP contract laboratory; NSF Reference Standards, which supplies pharmaceutical secondary reference standards to demonstrate the identity, purity, quality and strength of their products and ingredients; Becker & Associates Consulting, Inc., a leading clinical, regulatory and scientific consulting firm that specializes in U.S. FDA-regulated industries; and the NSF Dietary Supplements Certification Program. NSF International developed the only American National Standard for Dietary Supplements (NSF/ANSI 173) and tests and certifies supplements against this standard. NSF's Health Science Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America. NSF International offers ISO 13485 registrations for medical devices and CE Marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Water Division.

For more information or if you are interested in NSF service offerings, please contact David Trosin at dtrosin@nsf.org or 734-827-6856 or Casey Coy at coy@nsf.org or 857-350-4788.

About NSF International: NSF International is an independent organization that writes standards, and tests and certifies products for the food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.

MEDIA CONTACT: Greta Houlahan
Phone: 734-913-5723
Email: houlahan (at) nsf (dot) org

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