
Equipment:
All equipment have I.Q. (Installation Qualification) and O.Q. (Operation Qualification) to ensure preservation of functional characteristics as well as suitability of working with the equipment. Calibration process is periodically performed for proper performance of the equipment.
Sanitation:
Any building used in the manufactured , processing , packing or holding of the products is maintained in a clean and sanitary condition . There are standard operating procedures ( S.O.P. ) for cleaning of the equipment.
Documentation:
There is a well-designed documentation as a basis for consistency and as an aid in the evaluation of problems . The documentation contains , SOPs for cleaning , SOPs for working , batch records , certificates of analysis , labels , …
Premises:
Buildings used in the manufactured , processing , packaging or holding of the products are of suitable size , construction and location to facilitate cleaning , maintenance and proper operations.
Personnel:
Each person engaged in the manufacture , processing , packing or holding of the products have education , training and experience or any combination there of to enable that person to perform the assigned functions.
Each person responsible for supervising the manufacture , processing , packaging or holding of the products has the education , training and experience or any combination there of to perform assigned functions in such a manner as to provide assurance that the products have the safety , identity , strength , quality and purity that they purport or are represented to possess. |