Operating systems Good Manufacturing Practice

Traceability systems already exist in the food contact material distribution chain, mainly to address quality problems that may arise with use. ISO-certified companies, as well as companies operating using Good Manufacturing Practice, not only adopt these systems internally, but also require their suppliers, service companies and manufacturers to use them, so that traceability is a common and widespread feature of food contact materials in the European... 

Beyond requirements related to sanitation, however, manufacturers, processors, packers, and distributors should establish and exercise other appropriate systems of controls throughout their operations, including food safety assurance systems such as Hazard Analysis and Critical Control Points (HACCP), where applicable, to ensure that FCC substances are safe and otherwise suitable for their intended use. These controls, together with the regulations cited above, constitute good manufacturing practices. While the... 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

Authorized written standard operating procedures (SOPs) for all sections of Good Manufacturing Practices guidelines are retained for reference and inspection. These SOPs are regularly reviewed and kept up to date by authorized persons. The reasons for revision are documented. A system is in place to ensure that only current SOPs are in use. Records of SOPs for all computer and automated systems are retained where appropriate. 

Audits on all systems, procedures and operations should be regularly conducted in order to monitor compliance with and the effectiveness of Good Manufacturing Practice and Quality Assurance principles in the various operations and to allow for improvement and corrective measures where required. 

EDMS = Electronic Document Management System MMS = Maintenance Management System BMS = Building Management System RCM reliability-centered maintenance SHE = Safety, Health and Environment OEM = Operation and Maintenance CMP = Good Manufacturing Practice IQ= Installation Qualification OQ = Operational Qualification... 

---