欧美偏差验证培训资料CAPAs, Validation, and Deviation Training精选.ppt

A validation protocol is a detailed document relating to a specific part of the validation process e.g. the OQ for a manufacturing vessel. It outlines the tests that are to be carried out, the acceptance criteria and the information that must be recorded. It also defines the approval process for the validation. The protocol should clearly describe the procedure to be followed for performing validation. It should include at least the objectives of the validation and qualification study, the site of the study, the responsible personnel, a description of the equipment to be used (including calibration before and after validation), SOPs to be followed (e.g. the operation and cleaning of the equipment) and the standards and criteria for the relevant products and processes. The type of validation and time/frequency should also be stipulated. The processes and/or parameters to be validated (e.g. mixing times, drying temperatures, particle size, drying times, physical characteristics, content uniformity, etc.) should be clearly identified. The results obtained during the performance of the validation, must be recorded. The validation report reflects the final test results and other documents such as instrument calibration certificates. It is on the basis of this report that the decision is taken on whether a particular process is judged to be validated. During the inspection, you must assess whether there is a written report reflecting the results after completion of the validation. The results should have been evaluated, analyzed and compared with acceptance criteria by the responsible personnel. All results should meet the criteria of acceptance and satisfy the stated objective. If necessary, further studies should have been performed. If the results were found to be acceptable, the report should been approved and authorized (signed and dated). The report should include the title and objective of the study, and refer to the protocol, details of material, equ