Computer System Validation in Pharmaceutical Industry

In the pharmaceutical industry qualification and computer system validation is very important in order to control the quality of the final product and in a way it is a process that verifies the results, documentation, and validation activities which are as per the regulatory guidelines. The computer system validation is a systematic process as it involves a number of critical and important activities during the product life cycle that verifies the final product quality and comply with the regulatory requirements.

The computer system validation is an approach to compliance for all types of computer systems including its validation, which provides evidence that the software used for the application meets the use for testing and processes that are as per the requirements. Computer system validation improves the reliability of the product and also ensures that the computer systems are running accurately, also system validation is a process that controls the change in process, data integrity, and records for training, etc.

Pharmaceutical industries need to validate the systems that are in the manufacture of pharmaceutical drugs, active pharmaceutical ingredients API, and drug products including biotechnology and biological products. 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, the computers which are involved in the research & development, laboratory lab notebook manual, batch record manufacturing process, analytical testing, stability process, raw material storage & packing should be validated. The validation of computers helps to handle the unanticipated challenges and complications during the process, avoid the loss of data, continuous improvements and updations, and increase the efficiency of the systems so that the quality is to be 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.

Pharmaceutical industries that are involved in the manufacturing of pharmaceutical impurities like Active pharmaceutical ingredients (APIs), excipients, biotechnology, etc need to establish a validation plan that the procedures, processes, equipment, and raw materials establish the expected results. As the advancement of technology is increasing in the field of automation, data integrity, process parameters, etc computer system validation is becoming very important and critical at all steps. Computer system validation requires the validation plan, training, and documentation including standard operating procedures sops, etc. 

In the Pharma industry computer system validation is the requirement as per the national and international guidelines like US Food and Drug Administration FDA 21 CFR 11, European agencies, ICH, and Good automated manufacturing practice (GAMP5). As pharmaceutical companies are in the manufacturing processes they have the stringent requirement of a computer validation system.

Requirement for Computer system validation:

FDA guidance as described in FDA 21 CFR 11, the requirement of validation of computer system, specific controls, the rule requirements, also the impact on the reliability, availability, authenticity, and records in some instances it is important to validate the computer system.

Good automated manufacturing practice refers to GAMP a system for producing quality equipment systems based on the concept of prospective validation for life cycle, further addressing FDA and other regulatory agencies for computer system compliance and validation. The GAMP helps to improve the compliance, efficiency, and quality and the interpretation of regulatory standards systematic approach for computer system validation. GAMP 5 is guidance for industries, an approach for computer systems, and its intended use 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 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 qualifications. 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.

In the pharmaceutical industry qualification and computer system validation is very important in order to control the Quality of the final product in a way it is a process that verifies the results, all the documents, and validation activities that are as per the regulatory guidelines. The computer system validation is a systematic process as it involves the number of activities during the product life cycle that verifies the final product quality and complies with the regulatory guidelines, like FDA audit and inspection, problem in the software application results in the product quality and finally affects results and also on the overall business.

Computer system validation has become an essential part of the FDA and regulatory guidelines as it gives consistency and also the advantages like quality improvement, product quality, and also the impacts on the overall system. Based on the above discussion computer system validation is a very critical and important step for instruments and software validation in the pharmaceutical industry and at present followed worldwide by the Pharma industry.  

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.‌