WASHINGTON—FDA has opened a period of public comment on several records collection issues with the dietary supplement good manufacturing practice (GMP) regulation. As part of the required 60-day notice required by the 1995 Paperwork Reduction Act, FDA published a notice in the Federal Register soliciting comment on:
- whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
- the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
- ways to enhance the quality, utility, and clarity of the information to be collected; and
- ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The agency called records an “indispensable component” of GMPs, noting the records required will provide a foundation for the planning, control, and improvement processes that constitute a quality control system. “Implementation of these processes in a manufacturing operation serves as the backbone to CGMP,” FDA wrote. “The records will show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to control the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective.”
This Federal Register notice details the manufacturing processes covered under recordkeeping requirements, reviews the range of potential parties responsible for such recordkeeping (manufacturers, packagers, distributors, etc.), and restates the locations of each recordkeeping provision in the original regulation. Also included are some details on the frequency of recordkeeping as well as data on the potential burden of such recordkeeping.
