Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more
GENERAL: SIFTING, MIXING ANG GRANULATION: COMPRESSION (TABLETS): COATING (TABLETS): FILLING OF HARD GELATIN CAPSULES: Empty Capsule shells shall be regarded as drug component and treated accordingly. They shall be stored under conditions which shall ensure their safety from the effects of excessive heat and moisture. PRINTING (TABLETS AND CAPSULES): PACKING OPERATION: Before packaging operations are … Read more
QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more
The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908
