The US Food and Drug Administration (US FDA) has announced a proposed collection of information on the current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—21CFR Parts 210 and 211. The document has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The FDA is reviewing the comments which were submitted on October 31, 2011.

Under Part 211, there are a set of 20 standard operating procedures (SOPs).  According to the revised documents,  Section 501(a) (2)(B) of the Federal Food, Drug, and Cosmetic (FD&C ) Act, a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to with Current Good Manufacturing Practices (cGMPs).

The  SOPs  include  for the quality controls and the sanitation procedures which also included the use of suitable insecticides, investigations, recalls, reports of inspectional observations, among others.

The key objective of the revised guidelines according to the regulatory authority is to ensure that such drug meets the requirements of the FD&C Act. The manufactured drug is safe, has the identity and strength, which could help meet the quality and purity characteristics, which it is represented to possess.

The FDA has the authority under Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding cGMP procedures for manufacturing drug products.

The cGMP regulations help ensure that drug products meet the statutory requirements for safety and have the  represented identity, strength, quality, and purity characteristics.

The information collection requirements in the cGMP regulations provide FDA with the necessary details  to protect public health and safety.

The new draft  calls to establish accountability in the manufacturing and processing of drug products which would  provide for meaningful FDA inspections. This would enable manufacturers to improve the quality of drug products. The record keeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product.

The general requirements for record keeping under part 211 (21 CFR part 211) are that, all  production, control, or distribution records associated with a batch required to be maintained in compliance with part 211. It  must be retained for at least one-year after the expiration date of the batch. For certain over the counter (OTC) drugs, it would be three years after distribution of the batch.

Although most of the cGMP provisions covered in this document  were  created many years ago, FDA  sees that there are   some existing firms expanding into new manufacturing areas and start-up companies which will need to create SOPs, stated the draft.

The FDA has assumed that approximately 100 firms will have to create up to 25 SOPs for a total of 2,500 records. It  estimates that it will take 20 hours per record keeper to create 25 new SOPs for a total of 50,000 hours.

Indian pharma industry is of the view that being one of the world’s largest drug manufacturers, the revised cGMP guidelines will make the sector far more transparent and efficient.