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 ...

1. Do the packaging operations proceed following the instructions and using the specified materials described in the Master Packaging Procedure? 2. Are the details of the operation recorded on the Batch Packaging Record? 3. Is only one product batch and packaging size on a line at any given time? 4. ...

1. Is validation, properly done to all critical production procedures? (Indicate all critical production procedures for which validation is done? a. conducted in accordance with previously defined procedures? b. result maintained? c. extension and degree dependable on the value and complexity of the ...

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 ...