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  • Computer System Validation in Pharmaceutical Industry

    In the pharmaceutical industry, computer system validation (CSV) is essential for guaranteeing overall sufficient quality control of any final product. CSV is essentially a process used to track and verify different results, documents, and other validation activities.

    What is Computer system validation?

    CSV is a systematic process that involves a number of critical and important activities during the product life cycle, verifying that the final product quality complies according to regulatory requirements and will produce information or data that meets defined requirements.

    Computer system validation checks the efficiency, and effectiveness and assures reliability, consistency, and accuracy of the system for the purpose for which it is designed. Therefore, CSV is an approach to compliance for all types of computer systems including its validation which provides the evidence that the software used for the application meets the use for testing and processes that are as per the requirements.

    Generally, CSV improves the reliability of the product and also ensures that the computer systems are running accurately system validation is the process that controls the change process, data integrity, and records for training, etc.

    Pharmaceutical industries need to validate the systems that are in the manufacture of pharmaceutical impurities, active pharmaceutical ingredients APIs, and drug products including biotechnology and biological products. CSV is a distinctive process that maximizes effectiveness and enhances quality. Evidently, the computer systems which are involved in the manufacturing of pharmaceutical products should meet the standards as per the industry norms.

    Computer system validation in the Pharmaceutical Industry

    In the pharmaceutical industry, any computers involved in the following processes should be validated; research & development, laboratory lab notebook manual, batch record manufacturing process, analytical testing, stability process, and raw material storage & packaging.

    The validation of computers helps to handle any unanticipated challenges and complications during processes, avoid loss of data, continuous improvement and updates increase the efficiency of the systems so that the quality is built in the entire system at all the steps. Overall the complete process is controlled in a defined manner so that the final results of the production will not differ over time.

    A critical process to control the digital development of pharmaceutical companies

    The pharmaceutical industry involved in the manufacturing of pharmaceutical products like Active Pharmaceutical Ingredients (APIs), excipients, biotechnology, etc. needs to establish a validation plan that the procedures, processes, equipment, and raw materials establish the expected results. Consequently, as the advancement of technology is increasing in the field of automation, data integrity, and process parameters computer system validation is becoming very important and critical at all steps.

    In the pharmaceutical industry, CSV is a requirement per national and international guidelines such as the US Food and Drug Administration (FDA) 21 CFR 11, European agencies, ICH, and Good automated manufacturing practice (GAMP 5). As pharmaceutical companies are in the manufacturing processes they have the stringent requirement of a CSV.

    The requirements for computer system validation

    Computer system validation requires the validation plan, training, and documentation including standard operating procedure (SOP). FDA guidance as described in FDA 21 CFR 11; the requirement of validation of computer systems, specific controls, rule requirements, impact on reliability, availability, authenticity, and records.

    As per the FDA guidance the quality system regulations require that “when computers or automated data processing systems are used as part of the quality system or production, the (device) manufacturer shall validate computer software or its intended use according to protocol”.

    Good Automated Manufacturing Practice (GAMP) is a system for producing quality equipment based on the concept of prospective validation for the life cycle addressing FDA and other regulatory agencies for computer system compliance and validation. The GAMP helps to improve the compliance, efficiency and quality, and interpretation of regulatory standards systematic approach for CSV. GAMP 5 is guidance for industries, an approach for computer systems and its intent to be used in a very efficient and effective manner.

    Good manufacturing practice for Active Pharmaceutical Ingredients (Q7), as per the guidelines the computer system should be validated, and also it depends on the complexity, diversity, and criticality of the computerized system. The computer hardware and the software should perform and demonstrate the assigned task with proper installation and operation qualification as it is important for the proper functioning of the system. Unquestionably, the computer system should have the control to prevent any unauthorized access or change in data; any changes in the computer system should be as per the procedure, and authorization.

    Conclusions

    The computer system validation is a systematic process as it involves a number of activities during the product life cycle that verifies the final product quality and compliance as per the regulatory guidelines. In the pharmaceutical industry qualification and computer system validation is very important in order to control the quality of the final product. Hence, it is a process that verifies the results, all the documents, and validation activities that are as per the regulatory guidelines.

    Albeit, CSV has become an essential part of the FDA and regulatory guidelines as it gives consistency and also the advantages like improved quality, product quality, and also the impacts on the overall system. Based on the above discussion Computer system validation is very critical for instrument and software validation for the pharmaceutical industry and presently followed by the Pharma industry worldwide.  

    FAQs

    What is FDA Computer system validation?

    FDA Computer system validation is the software specification that conforms to user needs and the intended uses and that the particular requirement is implemented through the software and can be consistently fulfilled.

    Why do we need computer system validation?

    Computer system and software validation provide the confirmation that the systems are compliant with the latest regulations and are suitable for their intended purpose.

    What is the importance of computer system validation?

    Computer system validation is a process that must be validated for the intended use and ensure that the software or hardware used in the system should be done in line with regulatory requirements.

    References:

    • Guidance for Industry Part 11, Electronic Records; Electronic Signatures -Scope and Application Pharmaceutical CGMPs. 2003, www.fda.gov/media/75414/download.
    • “What Is GAMP®?” ISPE | International Society for Pharmaceutical Engineering, 5 July 2022, ispe.org/initiatives/regulatory/what-gamp.
    • Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry. 2016, www.fda.gov/files/drugs/published/Q7-Good-Manufacturing-Practice-Guidance-for-Active-Pharmaceutical-Ingredients-Guidance-for-Industry.pdf.‌
    • “Guidance for Industry – COMPUTERIZED SYSTEMS USED in CLINICAL TRIALS.” U.S. Food and Drug Administration, 2018, www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials.
    • General Principles of Software Validation; Final Guidance for Industry and FDA Staff This Document Supersedes the Draft Document, “General Principles of Software Validation, Version 1.1, Dated June 9, 1997. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research. 2002, www.fda.gov/files/medical%20devices/published/General-Principles-of-Software-Validation—Final-Guidance-for-Industry-and-FDA-Staff.pdf.