1 Site Master File. 2 Air Quality Manuals. 3 Water Quality Manual. 4 All process-related SOPs. 5 Standard Testing Procedures (STPs) and Specifications for Raw Material, Packing Material, Intermediate, and Finished Product. 6 Market Complaints Record. 7 Calibration Record. 8 Process Validations report ...

1. Is the area equipped to avoid cross-contamination and physically separated from the other rooms by walls or other type of separation? 2. Are lighting and ventilation adequate? 3. Is there temperature and humidity control, where required? 4. Are weighing and dispensing area maintained in a clean ...

Personnel =>> Is up-dated organization chart showing an arrangement for quality assurance including production and quality control available? =>> Is updated technical staff list is available with the following information – Name, qualification and years of relevant experience of responsible pharmacists, ...

1. Is high level of sanitation and hygiene implemented in every aspect of manufacturing of drug product? 2. Are protective measures taken to avoid direct contact of operators and materials (raw materials and drug products) and assuring protection of product from contamination as well as the safety of ...

1. Is brief description of major production and quality control lab. Equipment indicating construction, validation and suitability of other materials (polypropylene, chrome plated brass, PVC, non-reactive plastic materials) provided? 2. Are the equipment of appropriate design, construction and adequate ...

• To ensure the reliable production of water of the required quality are water treatment plants – A. designed and constructed? B. maintained and operated?. • Are water sources, water treatment equipment and treated water checked for contamination and maintained regularly for A. chemical? ...