Good Laboratory Practice (GLP) is a well known guideline to enhance quality and to check validity of laboratory data. This guideline helps to define and standardize the planning, reproducibility, recording, reporting, monitoring and documentation process within an organization.
In early 1970’s, inspection of non-clinical data submitted to FDA for New Drug Application (NDA) filling from major pharmaceutical manufacturers discovered that there was insufficient planning, inadequate data handling and poor documentation. There were fraud cases in which animals which had died during the study due to improper treatment were replaced with other animals without mentioning in research.
It was a big question on its integrity. Hence in 1976 such disasters led to the publication of proposed regulation on GLP with formation of the Final Rule in June 1979 (21 CFR Part 58). After that Organization for Economic Cooperation and Development (OECD) published a compilation of Good Laboratory Practices. Then on October 29, 1984, the FDA published a proposed amendment to the GLP to minimize misconducts held in laboratory practice and non-clinical laboratory studies. This final amendment was issued on September 4, 1987, and became operational on October 5, 1987.
The enforcement of GLP certification and audits of analytical laboratories is the responsibility of the FDA and the EPA in the United States and the Departments of Health and Social Affairs in the OECD and EU member countries. Each of these government agencies may perform detailed examinations of any laboratory facility within its jurisdiction at reasonable times and in a reasonable manner. Such audits involve the inspection of the facility, equipment records, and specimens and may also include the investigation of an experiment in depth from raw data to final reports.
In India, with the approval of the Union Cabinet, A National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) was established by the Department of Science & Technology, Government of India in 2002. After one year , in April 2003 India became a provisional member of the OECD’s working group on GLP , conducting major activities like GLP inspections, grant of GLP certificate, GLP compliance monitoring of certified test facilities, awareness generation on GLP, training on OECD principles of GLP and training of GLP inspectors to maintain quality inspectors for conducting GLP inspections on behalf of NGCMA. The mandatory GLP exists in India from November 1, 2010.
The GLP principles help to maintain the worthy laboratory practice, since its implementation continues to increase the efficiency of laboratory practice with its guidelines in every minute area of the practices. Although all the information about laboratory practice was provided with it, still there were some deficiencies or lack of perfection in areas like the laboratory work or data collection and interpretation was carried out manually to avoid chance of mistakes, lack of automated system, poor documentation, lengthy manual paper work etc. This led to implementation of various recent trends like computerized system, laboratory automation systems, document control, document management, change control, training management, compliance audit management and electronics signature and e-records. This has eased the tough task of complying with GLP guidelines.
Documentation is the pioneer of every work especially for research work.
In earlier days, all documentation were done manually which lead to major mistakes but with introduction of FDA 21 CFR Part 11 focusing on use of E-signature and E-records it has now become easy.
In March 1997, FDA introduced 21 CFR Part 11 for rules on the use of electronic signature and electronic records, Part 11 applies to electronic records and electronic signature that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in Federal Food, Drug and Cosmetic Act, the Public Health Service Act or any FDA regulations.
This helps to maintain records in place of paper format. This improves data storage, handling, searching with ease. Electronic signature has some advantages like its unique identity to one individual. It prevents unauthorized uses and act as safeguard. E-records are also important part of the improvement of laboratory practice enabling fast and proper documentation work.
Also various softwares and techniques are adopted by industries for good quality based and properly managed documentation work. However now-a-days regulatory requirements, inspection and enforcement practices are quite dynamic. What is appropriate today may not be appropriate tomorrow. Regulations change but more often it is the inspection practices that change. In the early 90’s the focus of inspections was on basic requirements of GLP, but then it changed to equipment hardware and later on to software and computer systems. Today, the clear focus is on data security, traceability and integrity of electronic records driven mainly.
To survive in the global pharmaceutical market , pharmaceutical companies are applying new approaches to maintain quality and to enhance productivity. The modern trend of incorporating software solutions into existing business systems has addressed the basic needs of implementing changes in the majority of businesses. However some inheritance systems lack the infrastructure to have capacity for changes to existing SOPs and processes. For this reason, successful companies approach a concept of change control that ensures all changes made to SOPs are properly documented without any unnecessary disruption of services. For example, master-control change control software allows efficient planning, implementation, accomplishment that is best fitted to firms need for compliance.
Process Automation System turns out to be a major breakthrough in laboratory practice. Various automatic systems were established during past few years for aiding the manual laboratory practice. Simple and normal laboratory work can be done by applying automated systems that can enhance quality and accuracy in data management and collection.
Today , the use of trouble-free and straightforward computerised techniques have incredibly increased and have become an integral part in various laboratory processes. This system involves data-processing, storing, interpretation, reporting and maintaining in fully automated way. They are essential for conducting various study and process on regulatory purposes. Hence it is necessary that they are developed, validated, operated and maintained in ways which are compliant with the GLP principles.
For planning, conducting and reporting of studies , there may be various computerized systems for several purpose like the direct or indirect capture of data from automated instruments, operation or control of automated equipment and the processing, reporting and storage of data.
For these different processes, computerized systems can vary from a programmable analytical instrument or a personal computer to a laboratory information management system (LIMS) -with multiple functions.
GLP has given certain principles for computerized systems like responsibilities, personals, training, facilities and equipment (hardware & software), maintenance and disaster recovery, and the last but most important is study directors, who are responsible for overall conduct of the studies.
The study director’s responsibility for data recorded electronically is the same as that for data recorded on paper and thus only systems that have been validated should be used in GLP studies. The computerized data should be well maintained and protected from the lose and misinterpretation by preventing unauthorized access and changes and the potential for corruption of data by viruses or other agents should also be addressed.
It can be said that post GLPs implementation to present time, it has gone through a drastic change which includes recent trends like laboratory automation to computerized systems, e-records and various laboratory based software like master control.
The various testing laboratories can enhance their performance standards in terms of quality and gain global acceptance by adhering to GLP compliance by implementing recent trends. Though it is true that it requires huge investment, it will definitely be rewarded by quality services and unlimited business opportunities across the globe.
Dr Mrunali. R. Patel is Assistant Professor and Bhavin J. Bhalani is M Pharm student of Indukaka Ipcowala College of pharmacy. Dr. Rashmin B. Patel is Assistant Professor, A. R. College of Pharmacy & G. H. Patel Institute of Pharmacy, Vallabh Vidyanagar , Gujarat.