GMP Audit checklist for Starting Materials Storage

Storage of Raw materials

• Are areas properly controlled and clearly defined for the storage of starting materials?
• Do controlled entry requirements exist for storage areas?
• Is there a proper quarantine and release system for starting materials?
• Are standard operating procedures followed?
• Are the conditions for storage system evaluated?
• Are raw materials of animal origin stored in controlled environments?
• Are raw materials of vegetable or animal origin or those used in cosmetics by cold processing methods free from contamination?
• Are the details of origin, source and manufacturing method documented for raw materials of animal origin?
• Is an inventory log maintained?
• Are the materials segregated during storage to avoid cross examination or mix-up with other materials?
• Are the raw materials stored in specified conditions to protect them from contamination or exposure to heat, sunlight, moisture and cold?
• Are there distinct storage areas for materials which need refrigeration?
• Are the raw materials monitored regularly for stability?
• Does the storage system have a continuous monitoring of backup power supply, alarms and temperature?
• Is pest control programme followed to ensure the safety of the products?
• Is the reference reagent stored allowing them to be easily identified with integrity?
• Are the containers of materials closed or boxed or bagged?
• Are the boxed items stored off the floors to allow identification and cleaning?
• Are the containers labelled for easy identification and control?
• Are the raw materials tested and verified for their identity, physical & chemical properties, contamination by chemical agents or microbes?
• Are the materials not meeting the specified criteria are identified and controlled to prevent further use?
• Are proper records maintained for the time, temperature and other conditions?
• Are the control records maintained for raw materials?
• Are the records maintained for two years after expiry date?
• Are there written procedures for identifying the storage time where the components, containers and closures should be reexamined for use?

Raw materials, starting materials storage, gmp audit checklist

• mcrhrdi.gov.in.
• fda.gov
• gmp checklist