UNITED STATES Fourteen years in the making, Good Manufacturing Practices have arrived in the US in the form of an 815-page document that spells out the Food and Drug Administration's view on how to go about the manufacture of an estimated $22 billion worth of dietary supplements each year. The FDA estimates compliance costs between $62,000 and $99,000 in the first year and between $38,000 and $61,000 annually after that.
Companies have one (large companies), two (medium companies), or three (small companies) years to comply with the regulations. So, quite logically, they are seriously beginning to assess their compliance options. Can in-house quality experts handle the job? Are GMP consultants required? Which third-party certifier is best?
Third-party certification is the most sure-fire route to compliance. Companies such as Covance, Cantox, NSF International and US Pharmacopoeia (USP), as well as trade associations such as the National Products Association (NPA) and the Council for Responsible Nutrition (CRN), offer certification services that match GMP requirements to varying degrees.
Some certifiers will go beyond GMP demands as part of their standard service, while others seek to more closely match the regulation to the letter. Knowing exactly what is required and what each certifier offers can save companies both time and money.
For instance, NSF has established Global Lifescience Solutions to perform preliminary company audits. "Our goal is to help manufacturers improve their quality programmes from initial implementation to ensuring ongoing compliance," said general manager Aline Lindbeck.
USP spokesperson Ruth Miller noted typical discrepancies, in that USP will test for pre-market chemistry and manufacturing controls even though these are not required in the GMP regulations.
The NPA's vice president of scientific affairs, Daniel Fabricant, said a final GMP audit could take up to a week depending on the size of the company, with a preliminary audit taking up to a year to bring a company up to speed. "The preliminary audit is important because many companies are nowhere near where they need to be," he told Functional Ingredients.
"There are a lot of auditors out there but most do a good job. It is the private consultants I would be most wary of. We have auditors who have worked with the FDA for 35 years so they know what they are doing, but there are many with minimal experience."
The NPA has established a programme in China in conjunction with USP, where GMP testing is also being ramped up as US imports increase. Other certifiers with a presence in Asia include Covance, which has established a centre in Singapore to test Asian products heading to the US, as well as Schuster and NSF, which recently set up shop in China.
Covance said it could simplify the export process by pre-authorising ingredients.