Leveraging Your NSF Certification: Now that you've received NSF Certification ... why not leverage the Mark to your advantage.
By Casey Coy, Partner at NSF-DBA Pharma, part of NSF International’s Health Sciences Division
In many countries around the globe, certain medicines with a long history of use (giving us confidence in the safety and efficacy of the active substance molecule) are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known and hence often judged low risk.
But wait a minute. This “low risk” takes no account of the conditions and standards under which the OTC medicine is made, or the security and quality of the supply chain used for its active ingredient(s) and excipients. In the U.S., around 80 percent of the APIs used in drug products are imported, often from low-cost sources in China and India.
From a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine.
In some countries, OTC manufacturers are treated the same way as other drug manufacturers – their products are after all medicines ¬– and are inspected to the same standards and at the same frequencies. In the U.S., OTC manufacturers must meet 21 CFR 210/211 and good manufacturing practices (GMPs), but due to resource issues, the FDA has not always inspected OTC manufacturers at the same frequency as drug manufacturers.
Remember, the responsibility for the quality of OTC medicines, including the need to comply with GMPs and to have known supply chains, sits with the firms marketing the OTCs and the manufacturers they choose to use. So is all well then?
Probably not. The situation has become very public recently as consumers see an absence of many well-known OTC brands on shelves. Two very large firms supplying OTCs, previously with reputations for high quality, are now being chastised for their lack of attention to quality and GMPs.
The margins in OTC manufacturing can be small, but that must not be an excuse for OTC firms to be unaware of, or to ignore, the expectations of GMPs and modern quality management thinking to protect the most important factor: the patient.
To meet this need for all stakeholders, NSF International has developed a global protocol to assess whether an OTC pharmaceutical or prescription drug manufacturer complies with GMPs as outlined in the Code of Federal Regulations (21 CFR 210 & 211).
The new protocol, NSF P414: 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 to produce OTC drugs such as 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, packaging and labeling.
Regulators and industry representatives, including America’s largest drugstore chain, Walgreens, have championed the development of the NSF 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 NSF regulatory-based protocol focuses on quality management and provides companies that outsource 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) and 21 CFR 210 & 211.
The NSF protocol for OTC and prescription drugs builds on NSF’s significant expertise in pharmaceuticals and dietary supplements and furthers its mission to protect public health. Vendor qualification is a crucial component for pharmacy retailers to ensure they receive high quality OTC and prescription drugs from their vendors and to avoid potential recalls. The significant costs involved in a product recall are not only absorbed by the drug manufacturer, but the retailer as well.
NSF is currently forming a joint committee to develop the protocol into an American National Standard for OTC and prescription pharmaceuticals.
For more information on NSF’s protocol for OTC drugs, or to join the joint committee, contact Austin Caudle at acaudle@nsf.org or +1 734.545.3376 (mobile).