India’s pharmaceutical and biotechnology companies are earnestly implementing Good Laboratory Practices (GLP) in order to garner the contract research opportunities not just from India but also from the global markets. From Anthem Biosciences to Bioneeds and Venus Medicine Research Centre (VMRC) are accredited for Good Laboratory Practices (GLP) and norms on Organization for Economic Cooperation and Development (OECD) Principles by the National GLP and Compliance Monitoring Authority (NGCMA).
According to a report, “India has achieved the status of full adherence to Good Laboratory Practices (GLP) certified by the Organization of Economic Co-operation and Development (OECD). The 34-member OECD includes some of the world’s most advanced countries such as the US, the UK, Canada, Australia, Sweden, Switzerland, Denmark, Hungary and Korea. With this certificate, India has become the third key emerging economy, after South Africa and Singapore, to join the OECD system for mutual acceptance of data in the assessment of chemicals, ensuring that the results of non-clinical chemical safety tests done here will be accepted in all other member countries. Earlier, manufacturers wanting to export pharmaceuticals and agro products had to get the tests done overseas.”
It was in November 2010, that the Ministry of health and family welfare notified the Schedule L-I of Rules 74, 78 and 150 E under Drugs & Cosmetics Third Amendment Rules 2008 for compliance of GLP. With Schedule L-I of Rules 74, 78 and 150 E, all pharmaceutical companies needed to adhere with the GLP and make the necessary requirements of premises and equipments. The lab needed to have a qualified team to carry out all technical activities for the implementation of documented quality system. Now, although GLP norms are mandatory for all the labs from 2010, most of the laboratories are yet to comply with the norms.
The Indian pharma industry, consisting of around 20,000 units, is the world's third largest in terms of volume and has only a few GLP accreditations. Currently, there are 25 testing labs in India and eight Indian pharmaceutical companies to have received GLP approval. Given the cut-throat competition among pharmaceutical companies, this GLP accreditation will provide an edge to companies, said experts.
According to Dr. HV Raghunandan, Associate Professor, Department of Pharmaceutics, Coordinator - Industry Institute Interactions, JSS University, Office at JSS College of Pharmacy, Mysore, GLP ensures the reliability of data and also product quality and safety. It is applicable to chemicals, food additives, cosmetics and pharmaceuticals for humans and animals. India has set up the GLP under National Good Laboratory Practice which is with Department of Science and Technology.
“The certification is voluntary and compulsory to have before marketing any of the product. GLP is essential certification even for the bio availability and bio equivalence labs. Most of the laboratories are meeting these standards in India and the products manufactured and tested from such companies are being exported also. In pharmaceuticals manufacture GLP L1 compliance is must where in product safety and efficacy is assured,” added Dr. Raghunandan.
According to Dr Manu Chaudhary, joint managing director, Venus Remedies Ltd and director, Research, VMRC, the GLP accreditation is one of the most coveted certifications for R&D capabilities and this is another significant milestone in our efforts to ensure product quality, safety, reliability and excellence while preserving and improving human life through innovation. It gives our research an international credibility, which will translate into more business opportunities for the company and add to the reputation of our products and personnel.
Venus was endorsed as a GLP certified facility in August 2013. The certification is an attestation of the consistent reliability of the company's R&D tests and calibration . Besides it meets the company's strategic efforts to bring to the world novel breakthroughs that cater to critical care and super-specialty segments, including anti-infective or anti-microbial resistance, anti-cancer, neurology, pain management and wound care, she added.
Bioneeds, a dedicated pre-clinical contract research organization(CRO) major is poised to expand its presence in the US, EU and Australia after it bagged the OECD GLP certification from the National GLP-Compliance Monitoring Authority (NGCMA), Department of Science & Technology. The certification takes the company to a premium league of CROs. India is now a signatory to the Organization for Economic Co-operation and Development (OECD) Mutual Acceptance Data (MAD) agreement for GLP.
For NGCMA compliance, the company was assessed on parameters like stringent GLP documentation on safety, precaution measures, infrastructure, instrumentation and training. The key objective of the certification is to assess the ability of a company to be able to trace the animal trial data, which is a result of documentation retention,” said Dr. SN Vinay Babu, head, Bioneeds.
“The biggest challenge is the implementation of GLP through LIMS (laboratory information management system) and ensuring data integrity by adopting Local Area Network and monitoring system. The challenge is to ensure the cost of the product does not go up and GLP aspects are fully adhered. Ultimately, GLP ensures the product safety and quality and it is important for all the stake holders in the healthcare industry to consider and adopt,” noted Dr. Raghunandan.
On whether, GLP is the ultimate in highest quality standards for research labs in India, Dr. Raghunandan, pointed out that it embodied a set of principles that provides a framework within which 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, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides.
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.
Implementation of GLP will bring the Good Laboratory Quality Assurance. Schedule L1 requirement of Drug and Cosmetic Act 1940 is almost in line with the World Health Organization (WHO) and other international GLP guidelines. Implementation of L1 guidelines will be helpful to all the stakeholders in the country, added Dr. Raghunandan.
Process and computer-based validation
Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the emphasis of current and future pharma manufacturing operations, said Krishna Mohan, Asst. GM, Corporate QA and SME Validations, Aurobindo Pharma.
While validation is the process of establishing documented evidence to provide a high degree of assurance that a specific process will consistently produce a quality product,qualification is seen as an action to prove any equipment works correctly and leads to the expected results, he added.
Coming to lab equipment qualification, the regulators call for good automation manufacturing practice (GAMP) and good practice guide (GPG) software driven approach, continuum of computerized lab system USP (United States Pharmacopoeia) instrument driven approach, qualification for complex instruments and calibration for simpler instruments, said Mohan.
Lean Validation Concepts
The industry should now work to implement the Lean Validation Concepts: ASTM E 2500 to enable continuous process improvements and real-time monitoring. The concept is a latest trend in the quality control of drug manufacture. The pharma industry should take a cue from global pharma majors like Amgen, Pfizer, Genentech and Bristol Myers Squibb (BMS) which have adopted ASTM E 2500 to achieve 80 per cent reduction in duplication of testing and validation, said S C Singhal, vice president - Formulation Tech Ops, Dr Reddy’s Laboratories Ltd.