The Pharmaceutical Export Promotion Council (Pharmexcil) has asked the pharmaceutical manufacturing companies in West Bengal, irrespective of big or small, to immediately conform to Good Laboratory Practices (GLP) like that of GMP for the continuation of domestic marketing and for venturing into export business, as GLP has become mandatory in the country.
The union ministry of health had last year notified the Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Third Amendment Rules 2008 under which it was mandatory for the pharmaceutical industry in the country to comply the GLP by November 1, 2010.
In this connection, the Pharmexcil conducted a seminar-cum-interactive session in Kolkata recently. Pharmexcil has invited lab expert, Sambaran Mookerjee, the Production Manager of Dey’s Medical Stores (Mfg) Ltd, Kolkata to deliver on GLP-eCTD.
“GLP will very shortly become a mandatory rule like GMP, to be followed by drug manufacturing units, especially for companies engaged in export business. It, along with GMP, has become an essential tool to provide assurance of identity, quality and strength of pharmaceuticals. Resolutions have been already passed to make it effective from November 1 this year, hence it becomes part of Drugs & Cosmetics Rules,’ he said while addressing the leaders of SMEs in West Bengal.
While speaking in the seminar, he said GLP is a newly introduced schedule in the Drugs & Cosmetics Rules from November 1, 2010 and these practices were not addressed as a legal requirement until then. From November 1, 2011 onwards all the labs of the companies will have to conform to GLP norms to manufacture medicines. This is applicable to all the big players and SMEs.
Regarding the objective of the practices, he said LP embodies 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, agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. It helps assure that the data generated are a true reflection of the results obtained during the study and can therefore be relied upon when making risk or safety assessments.
At present, a number of countries require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetics, food products to establish through data that use of these products do not pose any hazards to human health and the environment. Non-hazardous nature needs to be established through studies and data which will be examined by the regulatory authorities of the concerned countries, he told the exporters of West Bengal.
Mookerjee said US FDA became aware of cases of poor laboratory practices all over the United States in early 1970s, when they decided to do an in-depth investigation on 40 toxicology labs. The FDA officials discovered several fraudulent activities and a lot of poor lab practices. In certain labs the equipments were found not calibrated to standard forms and they gave wrong measurements. Accounts of the lab study were incorrect or inaccurate, and the test systems were inadequate. This has led the US agency to frame norms for good laboratory practices, he said.
The practices make sure that the data submitted are a true reflection of the results that were obtained during the study. It promotes international acceptance of tests. Further it makes sure that data is traceable. It is meant to assist the approval and manufacture of products that are safe for consumers. In addition to this, GLP focuses on test systems, archiving of records and materials, apparatus, material and reagent facilities, quality assurance programmes, performance of the study, reporting of study results, Standard Operating Procedures (SOP) and personnel, and test facility organization.
Besides SOPs, the necessary process for any analytical laboratory is instrumentation validation. Data produced by faulty instruments may give an appearance of valid data. So, depending on instruments, calibration, re-validation and testing should be done frequently. The equipment records should include the name of the equipment and manufacturer, model or type for identification, serial number, date on which equipment was received in the laboratory and the copy of manufacturers operating instructions.
With regard to technical knowhow of the analyst, some acceptable proof of satisfactory training or competence with specific laboratory procedures must be established for each analyst. Mookerjee said qualification can come from education, experience or additional trainings, but it should be documented.