Many companies successfully implement a personal hygiene program, but do not review and adapt the program to the ever-changing regulatory environment, as well as other changes that can negatively impact medication safety. The implementation, maintenance and maintenance of a robust and effective human hygiene program to prevent contamination and cross-contamination should be based on a company`s risk acceptance threshold, industry practices, guidelines and regulatory requirements. “The regulations are then supported by detailed information on why the regulations are needed. Also included are instructions on how these regulations should be evaluated by an official inspector. “Each manufacturer should keep the records necessary to achieve and monitor compliance with these requirements.” The current regulations do not prescribe written cleaning and hygiene procedures for devices that come into contact with food. Cleaning and disinfecting food contact equipment is essential to prevent ready-to-eat foods (REEs) from being systematically contaminated with harmful bacteria that could establish themselves on the impure surfaces of appliances. Harmful bacteria such as salmonella and L. monocytogenes are known to contaminate RTE foods through unhygienic device surfaces. In addition, written cleaning and hygiene procedures facilitate the appropriate training and follow-up of employees responsible for these tasks. In particular, 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 820 Quality System Regulation, and ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients contain requirements that address personal hygiene. This report summarizes the written and oral comments submitted to the Agency in response to its announcements in the Federal Register and at three public meetings.
The report examines key ways to modernize food MPMCs, as suggested by respondents. Some comments related to issues that are not relevant to the modernization of CMP, i.B. those that are covered by other existing regulations or under development, and these were excluded from the report. Some comments also included details and regulatory language that was too long to be included in this report. However, the working group has endeavoured to capture and include the main theme of these comments. Finally, some comments on minor or technical changes to Part 110 of 21 CFR, which are also not discussed. A procedure should be established for the retention of all appropriate documents (p.B development history reports, scaling reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records). The retention periods for these documents must be indicated. Several commentators expressed concern about the terminology used to refer to written hygiene procedures. These commenters noted that the term “Standard Sanitation Operational Procedure (SSOP)” was associated with HACCP, and were concerned that the use of this term would confuse GMP programs with HACCP programs. The working group is aware that many food processors have voluntarily implemented HACCP plans and SSOPs. The Working Group does not believe that it is necessary to have separate terminology for the CGMP and HACCP programmes.
In fact, the term “hygiene standard operating procedures” was commonly used before it was included in HACCP regulations for farms regulated by the U.S. Department of Agriculture`s Food Safety Inspection Service. If processors already have POSPs that would meet a new requirement in Part 110 of 21 CFR for written hygiene procedures, the working group sees no reason why these processors could not continue to call these procedures PSPs. In addition, the HACCP requirements for SSOPs do not differ from the GMP requirements for written hygiene procedures proposed here. In recognition of the dual use of SSOPs, one commenter suggested removing the SSOP requirement from haccp requirements and making it a CGMP requirement. The Working Group recommends that the Agency seek further comments and suggestions on the appropriate use of SSOPs/written hygiene procedures and their relationship to the HACCP and CGMP programmes. Prepare the policy for the periodic review of documents. Ensuring that current industry practices and pharmacopoeia requirements are met by current versions of the documents Another commenter wrote that it “. Expanding access to processing records by making changes to food GMPs is not supported. It is certainly assumed that food companies are expected to keep records to document their own GMP compliance; However, the law does not allow access to the same records by FDA investigators.
One commenter suggested rewriting 21 CFR 110.93. This commenter proposed regulatory formulations that included sections on the storage and transportation of food with detailed provisions for all those that are too long to cite in this report. These provisions included requirements for the construction and maintenance of pest exclusion facilities, adequate lighting, proper refrigerated and frozen storage, storage and labelling of chemicals, hand washing, sanitation, pesticide use, shellfish storage conditions, stock rotation, recovery of food in distress, hygiene standards for food transport vehicles, and temperature monitoring of vehicles carrying potentially hazardous food. The final modernization option (item 7 above) is based on several comments recommending that the temperature requirements set out in 21 CFR 110.80(b)(3)(i) and 21 CFR 110.80(b)(3)(iii) be removed or brought into compliance with the current FDA Food Code. One commenter recommended removing the specific temperature requirements of 21 CFR 110.80(b)(3) and publishing guidelines for temperature control instead. The Working Group agrees that the specific temperature requirements in this Regulation may be problematic, as pathogens such as Listeria monocytogenes can develop at temperatures significantly lower than those indicated for refrigerated foods. .