Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOAnnex B: Facilities and cleaning, utilities and engineeringPrincipleThis Annex addresses in more detail some of the issues raised in Process Control (chapter 9),together with equipment cleaning and computerised systems. Buildings and equipment shouldbe suited to, and properly maintained for, the production, storage, and testing of API. Onlysuitable areas for manufacture, storage, and testing of raw materials, intermediates, and finalproduct should be used, and adequate utilities should be available.Sufficient engineering expertise should be in place to support and maintain production andpackaging processes in a GMP compliant manner.B.1 Facilities and equipmentB.1.1The location, design, and construction of buildings should be suitable for the typeand stage of manufacture involved, protecting the product from contamination(including cross-contamination) and protecting operators and the environment fromthe product.B.1.2Separate buildings and/or areas and/or equipment should be used for sensitisingagents, highly active or toxic drugs.B.1.3Where ventilation systems are necessary, they should be designed, constructed andoperated to protect both the operators and the API. Air intakes should be positionedaway from potential sources of contamination (such as air exhaust points).B.1.4Filters in ventilation systems should remove particulate contamination to a definedlevel determined as a result of filter validation, if appropriate. Recirculated air shouldnot cause demonstrable cross-contamination.B.1.5Facilities for sampling should protect against cross-contamination.B.1.6The environment in which pure and/or final API is handled (e.g. filtered/filled,packed) should afford sufficient protection against cross-contamination.B.1.7Laboratory areas for final product testing should be separated from productionareas.B.1.8Equipment should be designed, constructed, located, and used so as to minimise therisk of contamination or mix-ups arising during manufacture of API.54