Process Validation Protocol and Report free essay sample

To trigger changes in the validation strategy if there is any unanticipated developments d. A written validation protocol is also a basic requirement of regulatory agencies. What is a Validation Report? The validation report is a comprehensive summary that documents how the validation plan has been satisfied. The validation report should document the detailed results of the validation effort, including test Results. Wherever possible, test results should be expressed in quantified form rather than expressed as pass/fail. The report should be reviewed and approved by designated Management or departments responsible for the validation more specifically validation team. What constitutes a validation report? and in some cases acts as a communication tool it is recommended by regulatory agencies that a summary be used to communicate the outcome of the validation performed this where a documented report is necessary to prove that a validation is successfully accomplished according to the specified validation plan. We will write a custom essay sample on Process Validation Protocol and Report or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page The validation report should contain the following. 1 . Approved validation protocol. 2. Tabulated or graphical results, process monitoring (forms), and all analytical results of the validation batches. 3. A copy of the batch records and raw material releases. 4. The presentation of data should be done in the report and be easily understood and neat. 5. Special investigations or additional tests or retests to be explained in the report. 6. Change controls and Deviations to be reported. . The validation report should have a conclusion. 8. Recommendations may also be made in the report History of validation protocol and report: Why validation and the associated validation protocol and report gained importance, elow mentioned is the brief history of the validation and its associated system Prior to 1978 the pharmaceutical manufacturing was highly regulated, drug product quality and sterility testing was based solely on finished product testing i. e. t was tested only at the final stage of the release drug product this was clearly a major setback. For Sterile products USP Sterility Testing was the sole criteria for releasing the drug product in to the market. The following incidents shows the defect in the above criteria USP sterility -rest Defect Rate 1% 5% Detection Probability 95% Batch Size 60,000 units Source- United states code for federal regulations. in 1962 and the Septicemia in 1970s. Septicemia outbreaks are considered as the greatest incident. Sterility problems arose in this incident as the large volume parenterals (LVP) failed for sterility this led to 54 deaths and 410 serious injuries FDA inspections came into force leading to product recalls and plant closure. This led FDA to seriously look in to the aspects of LVP and SVP (Small volume parenterals) facilities problems, inadequate process specifications, SOPs and test data, No EM specs, sops, and test data. In 1976 FDA proposed changes to the GMPs due to the outbreak of these incidents focused on Sterilization Procedures, Steam and Dry Heat Sterilization, ETO, Depyrogenation, SIP, and filtration. Terms such as Validation, Protocol, and Qualification began to be used this can be considered as the seed for the implementation of validation and thus the introduction of concepts like process validation protocol and report. 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 re 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). protocol, details of material, equipment, programs and cycles used, together with etails of procedures and test methods. It should provide a comparison of the results with the acceptance criteria. In addition, it should include recommendations on the limits and criteria to be applied to all future production batches. It is common practice in many companies for the protocol and the report to be combined into a single set of documents. The protocol is approved as a form on which the test results are recorded as they become available. This reduces the amount of paperwork that needs to be stored and makes an overall assessment of the validation results easier to carry out.