Introduction
Quality control and assurance is not just about following laboratory protocols. It ensures that the results of a study are accurate, precise, reliable, and valuable. Thus, appropriate guidelines must be in place to ensure that companies maintain high standards of manufacturing products or the high quality of services offered. They also ensure that these products and services meet customer satisfaction, thus enhancing customers’ trust. Good laboratory practice and ISO standards provide a roadmap to ensure that each step in every process is accurate, traceable, and adequately documented.
What is Good Laboratory Practice?
Good Laboratory Practice (GLP) denotes a quality system guideline that oversees the organizational processes and conditions under which non-clinical studies are planned, conducted, monitored, reported, and archived. Overall, GLP helps ensure the quality and integrity of the safety data submitted to various regulatory authorities.
Primarily, GLP regulations were developed in response to concerns about the reliability and consistency of safety data submitted to regulatory agencies regarding the potential risk of different substances and chemicals to our health and environment. The key objective of the Good Practices Laboratory regulations is to standardize practices and procedures involved in non-clinical studies so that the relevant data obtained and reported are accurate, reliable, and traceable.
Some good practices in laboratory regulations include adherence to protocols and standard procedures in GLP bioanalysis, use of standard control samples while testing, calibration and maintenance of equipment, proper training of laboratory personnel, etc.
Although GLP is commonly associated with the pharmaceutical industry, companies involved in food additives, cosmetics, and industrial and agricultural chemicals also have GLP labs.
What do ISO Standards Mean?
ISO (International Organization for Standardization) standards refer to international guidelines that result in safe and consistent outcomes. These guidelines are internationally agreed upon by experts in different fields. ISO standards describe the best way to conduct any process and establish levels of homogeneity. Thus, ISO standards aim to improve the quality and safety of goods and services, including Bioanalytical Services.
ISO standards benefit companies and consumers. For companies, ISO standards ensure that the practices followed are internationally recognized, while for consumers, these standards help to establish the safety, quality, and trustworthiness of products and services.
These standards apply to technical and non-technical domains, including technology, manufactured products, food safety, IT, agriculture, healthcare, and transport. Currently, there are about 24106 different ISO standards that address diverse aspects. While some are specific, others are more general and serve as frameworks to manage diverse processes involved in businesses. For example, ISO 9001 is related to the quality management system, ISO 27001 with information security management, ISO 10002 assists with customer complaints, and ISO 13485 deals with the quality of medical devices.
Understanding the Difference
As evident from the above discussion, GLP and ISO standards are guidelines and regulations that help to ensure the quality, reliability, and consistency of processes and/or products. However, GLP is usually associated with non-clinical studies performed in the pharmaceutical industry and ISO standards for products and services linked to diverse technical and non-technical fields, including pharmaceutics.
Within the pharmaceutical industry, good laboratory practice offers a framework for planning, conducting, monitoring, recording, reporting, and archiving non-clinical studies. ISO standards, on the other hand, specify requirements for a quality management system in laboratories, including GLP labs. In the pharmaceutical industry, ISO establishes standards that help to maintain the quality, efficiency, and safety of drugs.
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Why are GLP and ISO Standards Important for Bioanalytical Services?
Bioanalytical results offer insights into the efficacy and safety of drugs, and these results are scrutinized by drug approval authorities such as the FDA before drug approval. Hence, bioanalytical laboratories must strictly adhere to relevant standards to ensure data integrity, validity, and reliability for drug approval.
In biotech and pharmaceutical industries, GLP and ISO not only aim to establish quality control but also inculcate a culture of excellence. The guidelines cover diverse aspects ranging from personnel training to equipment management. For example, in areas of documentation and traceability, GLP and ISO standards establish the need for comprehensive documentation of different aspects of laboratory processes, including GLP bioanalysis, study plans, standard operating procedures, reports, data, deviations, and amendments. They also ensure that the source of all data, material, and equipment used in the experiment can be traced and the results obtained in the study have integrity and reproducibility through proper processes of documentation of materials used and regular calibration of equipment.
In terms of personnel training and equipment management, GLP and ISO standards help to ensure that every personnel involved in laboratory work is adequately trained and qualified for their roles and responsibilities. They also help to ensure that the equipment used in a study meets specified requirements such as maintenance, calibration, and validation. They help to generate accurate and reliable results in a study. In addition, they outline the need for implementing specific quality assurance and quality control measures, such as audits, testing, root-cause analysis, and preventive and corrective actions. These steps help to identify areas for further improvement.
