b) Are any other steps of manufacture of the products relevant to this audit (such as packaging, sterilising etc, but excluding provision of raw materials) contracted out to other manufacturers? Yes complete details below No go to Question 25 Name of Address Product Step(s) of Manufacturer Manufacture c) If the manufacturer to be audited does not perform release for supply of the product, who does perform this step? Name of Address Product Manufacturer DOCUMENTATION / PROCEDURES a) Please provide a list of the Standard Operating Procedures (SOPs) and methods used on the site. (attach list if preferred) b) Please attach copy of Master Validation Plan, if any. COMPUTERS a) Are computers used for: monitoring status of raw materials, intermediates, finished product? controlling manufacturing operations? controlling stock levels? calculating formulation quantities?
b) Are any other steps of manufacture of the products relevant to this audit (such as packaging, sterilising etc, but excluding provision of raw materials) contracted out to other manufacturers? Yes complete details below No go to Question 25 Name of Manufacturer Address Product Step(s) of Manufacture c) If the manufacturer to be audited does not perform release for supply of the product, who does perform this step? Name of Manufacturer Address Product DOCUMENTATION / PROCEDURES a) Please provide a list of the Standard Operating Procedures (SOPs) and methods used on the site. (attach list if preferred) b) Please attach copy of Master Validation Plan, if any. COMPUTERS a) Are computers used for: monitoring status of raw materials, intermediates, finished product? controlling manufacturing operations? controlling stock levels? calculating formulation quantities?
form-fm-mql45.docx