Laboratories Accreditation by ISO/IEC 17025 plays a crucial role in enhancing the quality and reliability of pharmaceutical testing laboratories. Here’s how it helps:
Ensures Technical Competence:
This standard is all about ensuring that the lab has the correct tools and trained staff as well as appropriate methods of conducting the tests with a view of obtaining correct results. In the pharmaceutical world it can be considered as primary knowledge since in the majority of cases the product’s safety and efficacy depend on the accuracy of tests.
Standardization of Testing Methods:
One of the requirement of the standard is that testing has to be done using validated standard protocols and hence you get standard and accurate results. This is important in the pharmaceutical industry since it entails accurate measurement of active pharmaceutical ingredients, impurities and other crucial ingredients.
Quality Management System:
The requirements of laboratories that qualify for accreditation under ISO/IEC 17025 are mandatory to adopt QMS to oversee the management of its undertakings. It provides means for risk control and mitigation, change recognition and continuous improvement so the quality of testing outcomes in the field of pharmacy can be improved.
Traceability of Measurements:
The ISO17025 standard demands that all the measurements taken are traceable to the international standards. The test results are accurate and can be compared over time and across different times and locations is ensured by the traceability measurements.
Regulatory Compliance:
Accreditation according to the standard of ISO/IEC 17025 is considered widely in such agencies as the FDA and EMA as the certificate of technical competence of the laboratory. This can help pharmaceutical companies meet regulatory requirements and facilitate the approval process for new drugs.
Customer Confidence:
Accreditation assures customers, that the results of the tests conducted by the laboratory are credible and accurate. This is particularly important in an industry with high stakes, and errors can have serious consequences.
Improved Risk Management:
The standard emphasizes risk-based thinking, which helps laboratories to focus on identifying potential risks in their processes and take preventive measures. In pharmaceuticals, this is crucial for avoiding issues that could compromise product quality.
Global Recognition:
Organizations recognize ISO/IEC 17025 internationally, facilitating the acceptance of test results across borders. This is particularly useful to pharmaceuticals with business across different countries as it cuts time on testing and to market.
The accreditation of pharmaceutical testing laboratories by ISO/IEC 17025 is very essential as it improves efficiency of laboratory operations and compliance with standards which help in the development of good and quality pharmaceutical products in the market.
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