Testing of Drugs: An Insignificant Tool to Determine the Quality

Dr. Obaid Ali, R. Ph., Ph. D.

raditional and routine testing of drug may verify the level of compliance to its approved specifications in terms of presence of

therapeutic agent etc. and dosage form specific tests in products only, whereas, quality of Drug/ Pharmaceuticals can neither be tested after the product is manufactured via Quality Control Laboratory nor testing gives assurance of safety, efficacy and quality of products. Quality needs to be built in during the whole process starting from selection of supplier and raw/ starting materials, manufacturing practices to delivery of products for consumption. Good manufacturing practice (GMP) is the only answer after marketing authorization of product (which is supposed to be passed through a robust assessment and review process by regulatory agency) for consistent supply of similar quality products in the market. It is a system for ensuring that products are controlled according to quality standards and designed to reduce the possible risks in any pharmaceutical production that cannot be eliminated through testing afterwards. GMP via integrated System of Quality Management prevents errors that are difficult to catch through testing of the finished products. No mechanisms are in place in any part of the world other than GMP, that every batch or unit of batch is of the same quality as the units of medicine tested in the laboratory. Robust review process of dossier/ studies of products and GMP Compliance inspection of manufacturing plant are the major and principle tools to determine quality of medicine because testing has its inherent limitations as to date no current knowledge offers non-destructive alternatives for ascertaining the quality and safety attributes of every finished unit in the batch and again it is not a feasible or wise option to extend the testing on unlimited scale. The compendial procedures of testing are not by themselves designed that a batch of product is of standard quality unless not supported by GMP. National regulations and International guidelines on Current Good Manufacturing Practice (cGMP) provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Complying with the cGMP principles assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications effectively and tolerably control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into

practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While cGMP require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products. Take another example of injectable products which are supposed to be free from microorganism known as Sterility test. It should be recognized that the referee sterility test might not detect microbial contamination if present in only a small percentage of the finished articles in the lot because the specified number of units to be taken imposes a significant statistical limitation on the utility of the test results. This inherent limitation of testing procedure and laboratory, however, has to be accepted, because current knowledge offers no non-destructive alternatives for ascertaining the microbiological quality of every finished article in the lot, and it is not a feasible option to increase the number of specimens significantly. Global Bible of testing of drugs (Pharmacopoeia) itself state that these procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. A state of Sterility Assurance can be established only through the use of validated sterilization process or aseptic processing, if any, under appropriate cGMP and not by reliance solely on sterility testing.

[Ref: WHO, US-FDA, USP]

Author is awarded B. Sc., B. Pharm., M. Phil, Ph. D. degree and possesses over 16 years of professional experience. He is currently holding the office of Federal Government Analyst of Government of Pakistan and served Federal Government as Assistant Drugs Controller and Federal Inspector of Drugs.

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