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 personnel?
3. Is there any regulation for personnel entering the building and facility designated as limited access area?
4. Are smoking, eating, drinking, chewing or keeping plant, food, drink, smoking material and personal medicines restricted to specific areas and not permitted in production, laboratory, storage areas and other area where they might adversely influence product quality?
6. Are there any procedure of qualification and validation of sanitation and hygiene available?
7. Is there a program for control of pest, rodents, insects or birds?
8. Is the program appropriately designed so that the rodenticides, insecticides, fumigating agents and sanitizing material do not contaminate equipment, raw materials, packaging materials, in-process materials or finished products?
9. Are cleaning agents changed from time to time?
10. Are cleaning method monitored routinely by chemical and or microbiological method?
11. What are the cleaning methods/frequency for the water supply system, air handling system and dust extraction system?
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 personnel?
3. Is there any regulation for personnel entering the building and facility designated as limited access area?
4. Are smoking, eating, drinking, chewing or keeping plant, food, drink, smoking material and personal medicines restricted to specific areas and not permitted in production, laboratory, storage areas and other area where they might adversely influence product quality?
6. Are there any procedure of qualification and validation of sanitation and hygiene available?
7. Is there a program for control of pest, rodents, insects or birds?
8. Is the program appropriately designed so that the rodenticides, insecticides, fumigating agents and sanitizing material do not contaminate equipment, raw materials, packaging materials, in-process materials or finished products?
9. Are cleaning agents changed from time to time?
10. Are cleaning method monitored routinely by chemical and or microbiological method?
11. What are the cleaning methods/frequency for the water supply system, air handling system and dust extraction system?
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