PREMISES-DESIGN, CONSTRUCTION, LAYOUT AND MAINTENANCE QUALITY ASSURANCE (QA)
PREMISES-DESIGN, CONSTRUCTION, LAYOUT AND MAINTENANCE INTRODUCTION In any industry, manufacturing operations must be carried out under clean and hygienic. conditions. However, in the pharmaceutical industry, the condition of the premises assumes critical importance because of the nature of the products being manufactured. Both the external and internal environments must be geared to be conducive to maintain the quality and safety of drug products. Special care must also be taken to prevent contamination of the products and therefore, the location, design, construction and layout of premises is a vital part of the GMP regulations Premises refers to the buildings and facilities where pharmaceutical processing is done. These places must comply with cGMP requirements. LOCATION Premises must be located in a site that is of a size suitable to house all the different departments. The nature of manufacturing and testing to be performed, the magnitude of the operation in t...