Process Validation Protocol and Report - 1461 Words

Process validation Protocol and Report Chapter-1: Introduction In today’s highly regulated environment for development and manufacturing of Pharmaceutical /biopharmaceutical Drugs and medical devices there is a heavy requirement imposed by the regulatory bodies, for the manufactures of drug products to provide an appropriate amount of assurance that critical processes employed in producing a drug substance or drug product can be shown to be both doing the right job, and doing the job right is often referred to as Validation. FDA defines validation as. â€Å"Validation is a documented program which provides a high degree of assurance that a specific process will consistently and repeatedly produce a product meeting its predetermined†¦show more content†¦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. 7. 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, below 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. it 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 showsShow MoreRelatedContents. 1.Validation Scope3. 2.References And Documentation3.1533 Words   |  7 Pages  Contents 1. Validation scope 3 2. References and documentation 3 3. Structure of responsibilities 3 3.1 Management level 3 3.2 QA 4 3.3 Validation specialists 4 3.4 Vendor representatives 4 3.5 Engineering and technical specialists 4 4. Validation approach 4 4.1 Validation strategy 4 4.2 Risk assessment 5 5. Description of plant, process and product 6 5.1 Description 6 5.2 Process flow 6 6. Specific process considerations 7 7. Validation list and validation requirements 7 8. Key acceptance criteriaRead MoreReviewing The Data Validation Of Data Discrepancy In A Computer System908 Words   |  4 PagesDetailed description of the duties: Data validation is the process of testing the validity of data in accordance with the protocol specifications. Edit check programs are written to identify the discrepancies in the entered data, which are embedded in the database, to ensure data validity. The beneficiary will write the program according to the logic condition mentioned in the DVP. These edit check programs are initially tested with dummy data containing discrepancies by the beneficiary. DiscrepancyRead MoreImplementing A Structured And Organised Fashion2767 Words   |  12 Pagesthe laboratory a number of key factors such as processes, equipment, personnel, premises and documentation need to be considered. In order to consider these factors in a structured and organised fashion, a project plan with clear objectives and validation requirements for the project should be undertaken. 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