Good Laboratory Practices (GLP) is a sine qua non for the success of pharma industry and if neglected would badly impact the growth prospects of the industry. In fact the standard laboratory practices are essential for the very survival of pharmaceutical and biotechnology industry the world over.
The recent warnings by international regulators is a wakeup call for the Indian pharmaceutical players to get their acts together and upgrade facilities to the international standards to cash in on the upcoming opportunities in the global market place.
Despite bringing all major activities of drug manufacturing, research and development under GLP, the pharma industry in India has been lax in implementing some of the norms stipulated by national as well as international regulators. The industry needs to upgrade every segment right from documenting raw data, research reports, recording observations in laboratories, functioning of machinery, packaging lines, storage, transportation and personnel. All aspects should follow certain stipulated principles, standards and regulations to bring out the best quality medicinal products.
With the advancement of technology and fierce competition from the global players, the Indian pharma industry cannot afford to neglect strict implementation of GLPs any more. “Gone are the days when things could be taken lightly with regard to GLP norms. In this competitive world and with advancement of technology, the pharma industry cannot take a chance. Particularly the Indian pharma players need to regularly upgrade their facilities and laboratories in accordance with the standards to stay on the global radar or else it will not be too late for the industry to meet its nemesis. GLPs or GMPs should not be compromised. We should grow to the next level and prove that we are not lagging in GLP compliance .With a plethora of opportunities coming up with the patent expiry in the pharma industry, Indian companies should take a lead and cash in on the opportunities for better and sustainable growth in the future,” says, Krishna Prasad, CEO&MD Cito healthcare.
The pharmaceutical industry is one of the highly regulated industries in the world. The other related industries like healthcare, biotechnology and diagnostic centres also have laboratories that deal with experiments involving toxic and highly reactive and sensitive chemicals. Moreover the research and development laboratories also deal with activities involving chemicals, equipment and closed and controlled environments. To achieve successful results, the researchers or the drug manufactures have to abide by the standards of GLP.
As far as pharma industry is concerned, the GLP standards are stringent and highly regulated as it deals with various chemicals and drug products used in the manufacture of life saving medicines. In fact, GLP is an essential part of good manufacturing practice detailed in schedule M of the Drugs and Cosmetic Rules. It involves a number of good practices in quality control laboratory which are to be undertaken to carry out an analysis with a defined degree of accuracy and precision.
The biotechnology industry which involves making of vaccines, enzymes, serums and other related bio engineered medicinal products also have to keep their factories and laboratories GLP compliant. As the world is continuously evolving, so too are the diseases and various ailments. To contain diseases, it is imperative for the pharma and biotechnology industry to continuously work to discover new drugs, vaccines and manufacturing process and treatment methodologies.
As pharma and biotechnology industries are dealing with microscopic and cellular level organisms and atomic and molecular level chemical constituents that may exhibit rapid changes with the surrounding environment such as light, temperature, humidity, air, water and dust, it is important for the manufacturing units and testing laboratories to follow certain standard and good laboratory practices. Development of sustainable process and GLP further enables scientists to discover or invent newer products that work efficiently and accurately.
The mentor and guide that helps the pharma and biotechnology companies in Telangana and Andhra Pradesh states is the newly established United States Pharmacopeial (USP) centre in Hyderabad. This centre has been training and providing assistance to various pharma companies on GLP and other related regulatory and drug research standards.
Ashok Dang Director-Marketing & Technical Services at USP Hyderabad says, “USP is one of the the best research and analytical laboratories in Hyderabad. GLPs are essential to analyse the manner in which non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. For any organization to produce reliable data that complies with regulatory agencies, good laboratory practice guidelines, specifications and regulations, it is important to have advanced equipment and well trained staff.”
The origin of GLP
GLP was first introduced in New Zealand and Denmark in 1972 and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992.The OECD has since helped implement GLP in many countries.
GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. The website for the Medicines and Healthcare products Regulatory Agency-UK defines GLP as "a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments".
However GLP, a data quality system, should not be confused with standards for laboratory safety - appropriate gloves, glasses & clothing to handle lab materials safely.
Good Laboratory Practices regulations became part of the regulatory landscape in the latter part of 1970s in response to malpractices in research and development (R&D) activities by pharmaceutical companies and contract facilities used by them.
The malpractices included cases of fraud, but by far the most important aspects were the lack of proper management and organization of studies performed to generate data for regulatory dossiers.
The USFDA mounted a series of investigations in toxicology laboratories throughout the US. The results of these investigations revealed a situation that could only be dealt by imposing binding regulations. These regulations are the GLP regulations. GLP regulations were first instituted by USFDA, then by the US environmental protection Agency (EPA). Many other nations followed the USFDA footsteps later.
In 1981 the OECD also published GLP principles which now dominate the international arena. To date 30 countries have signed an agreement binding them to OECD GLP principles. Later other non-OECD countries also followed the suite.
The main objective of GLP is to regulate the practices of scientists working on the safety testing of prospective drugs. With the obvious impact on patients taking medicines and on people recruited for clinical trials, the safety of drugs is a key issue and GLP is seen as a means of ensuring that scientists do not invent or manipulate safety data and as a means of ensuring that studies are properly managed and conducted, thereby producing valid experimental data. GLP compliance is a guarantee that safety data are being honestly reported to the registration authorities. The results of these studies form the basis for the decision to proceed with clinical trials, prior to allowing a new drug into the market. GLP was imposed on industry by regulatory authorities in the same manner as Good manufacturing practice (GMP) and Good Clinical Practices (GCP).
Importance of GLP
The GLP regulations set the rules for good practice and help researchers perform their work in compliance with their own pre-established plans and standardized procedures. The regulations are not concerned with the scientific or technical content of the research programmes. Nor do they aim to evaluate the scientific value of the studies.
All the GLP standards, irrespective of their origin, stress on five important points. These include Resource, Characterization, Rules, Results and Quality Assurance. The World Health organization (WHO) also stresses on the above five points of GLP. These five points are stressed to the pharma companies during WHO training programmes.
Resource: The resource part particularly focuses on the organization and the personal aspects of an industry. GLP regulations require that the structure of R&D organizations and the responsibilities of R&D personnel are clearly defined. GLP also stresses that there should be sufficient staff to perform the tasks required. The qualifications and the training of staff must also be defined and documented.
Facilities and equipment: The regulations emphasize the need for sufficient facilities and equipment to perform the studies. All equipment must be in working order. To ensure this, a strict programme of qualification, calibration and maintenance must be adopted.
Characterization: In order to perform a study correctly, it is essential to know as much as possible about the materials used during the study. For studies that evaluate the properties of pharmaceutical compounds during non-clinical studies, it is a prerequisite to have details about the test item and the test system (often an animal or plant) to which the test item is to be administered.
Rules: Rules, protocols and written procedures are a vital part in GLP. The main steps of research studies are prescribed in the study plan or protocol. Being able to repeat studies and obtain similar results is a sine qua non for mutual acceptance of data and, indeed, a central tenet of the scientific method, so the details of routine procedures must also be available to scientists involved in the study. However, the protocol which provides the experimental design and time-frame for the study, does not contain all the technical detail necessary to conduct the study. These details are found in written standard operating procedures (SOPs). With the protocol and the SOPs , it should be possible to repeat the study exactly, if necessary.
Results: For achieving good results, a proper analysis of raw data is important. All studies generate raw data. These are the outcome of research and form the basis for establishing scientific interpretations and arriving at conclusions. The raw data must also reflect the procedures and conditions of the study.
Final report: The study report contains an account of the way in which the study was performed, incorporates the study results and includes the scientific interpretation of the data. The report is provided to regulatory authorities as part of the submission for registration and marketing approval.
Archives: Storage of records must ensure safekeeping for many years and allow for prompt retrieval.
Quality Assurance: Quality assurance (QA), as defined by GLP, is a team of persons (often called the Quality Assurance Unit – QAU) charged with assuring management that GLP compliance has been attained within the laboratory. QA must be independent from scientists involved in the operational aspects of the study being performed. QA functions as a witness to the whole non-clinical research process.