A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate in compliance with current good manufacturing practices (cGMP). One good approach to understanding these requirements is to read the underlying regulations. For finished pharmaceuticals this is 21 CFR Part 211.
The consequences of non-compliance can be dire and range from warning letters, to fines, to consent decrees. A consent decree is a form of injunctive relief against the violator which can include forced changes to current manufacturing practices as well as significant fines and reimbursement to the government for inspection costs.
Examples of recent FDA enforcement actions include:
- Genzyme Corporation recently signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant. (fda.gov)
- In a landmark case, Schering-Plough was found to have deficiencies in good manufacturing practices. The corporation signed a consent decree of permanent injunction with the Food and Drug Administration agreeing to take measures to ensure compliance with the FDA’s current good manufacturing practices and also agreed to pay $500 million to the U.S. Treasury. Additionally, the company has agreed to pay up to $175 million in future profits if it fails to adhere to the time lines established in the decree. (avmajournals.avma.org)
How can tobacco manufacturers avoid a similar fate? The first step in assuring compliance with cGMP’s is the establishment of a formal documented Quality System. The Quality System provides documented assurance that the product that was delivered to the customer was manufactured properly. It normally includes Quality testing data, manufacturing data, change control information, batch release and raw material data.
In creating the Quality System or enhancing the one you have, some of the first questions to be asked include: Do you have formal written and approved specifications? What type of document system do you have? Do you have SOP’s or documented processes? If so, do you manage them? Do you have training programs? Do you have training records? How do you handle production records? How long are they kept? Where are they kept? Do you do final quality testing and in process checks? If so, what and how often? Using what systems? What do you do if you find discrepancies?
Specialists in developing and implementing Quality Systems and establishing cGMP’s are available to aid the tobacco industry in complying with the FDA regulations, but it is important to start the process soon. Becoming compliant is not an overnight process and qualified resources will be in increasingly short supply as the deadline approaches.