Quality Assurance in the Drugs Laboratory

In order for the report and evidence presented in court to be of value, a regular programme of quality assurance must be entered into by the analyst and his laboratory. Records of the methods used should be available, along with documented assessments of the performances of each of the tests and instruments used. Such records are essential should the functionality of the tests or equipment be challenged. 

Any new method to be used in the laboratory should be rigorously tested, to ensure that reproducibility, repeatability and robustness comply with internationally 

In terms of ensuring that performance standards are met, it is preferable for the laboratory to participate in proficiency tests - both declared and undeclared. There are a number of these commercially available, or they may be prepared in-house, although this latter approach is always open to accusations of results fixing and bias. While many analysts are understandably nervous about such tests, when properly handled they can be used to improve the performance of the laboratory. 

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To understand the need for quality assurance in the drugs laboratory. 

Quality Assurance in the Clinical Laboratory using Drug Analysis as the Example... 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements5 are established as early as non-clinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in vitro experiments, focusing on early drug entities. These drug entities are tested under laboratory conditions to determine their potential safety risk. At this phase, human subjects (e.g., clinical studies) or field trials in animals are not involved. 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements are established as early as nonclinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in... 

This chapter deals with some methods of quality assurance, an important aspect of GLP (good laboratory practice) used to monitor drug analysis in the clinical laboratory. To ensure that the analytical results are of good quality, it is essential to find suitable methods to use for the routine procedures, and, in this connection, we discuss the use of internal and external standards and propose some methods for the documentation and verification of the analytical results, the quality of the results of GC/MS analysis being at the forefront of our discussion. 

A host of pharmaceutical substances can be identified and critically examined with the help of infrared spectroscopy. Hence, the latest versions of British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) contain the complete IR-spectrum of such pure pharmaceutical substances that are essentially included in the respective official compendium. These authentic IR-spectra are profusely used in many well-equipped Quality Assurance Laboratories in checking the purity of commercially available drugs before employing them in various formulations. 

Modem HPLC is adequately provided with complete data handling devices. Thousands of samples routinely analysed in Quality Assurance Laboratories in Pharmaceutical Industries/Bulk Drug Industries etc. are duly processed and the data stored in the computerised data-handling devices. Each stored data may be retrieved from the memory of the computerised device with the flick of a finger, as and when needed, in the form of print-out. 

The textbook on Pharmaceutical Drug Analysis would enormously serve the undergraduates, postgraduates, researchers, analytical chemists working in the Quality Assurance Laboratories, new drug development, production and control, teaching, or regulatory authorities. 

Eollowing finalization of drug substance synthetic routes and drug product formulation, the focus shifts to the development of robust and transferable methods for post-approval support at quality control units. It is important to remember during the final stage of method development that achievement of separation conditions is only one of the necessary parameters for successful method implementation. Extensive studies to measure robustness and quantitative method performance are conducted to assure that the method performs as intended in quality control laboratories. It should be emphasized that successful method development requires extensive cooperation between the development laboratory and the receiving quality control laboratories. 

According to 21 CFR 211.160(b), Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. ... 

Both barbiturates and benzodiazepines can be identified by using GC-MS methodologies, although each drug class requires a different pre-treatment routine prior to analysis. It should also be remembered, as with all chromatographic analyses, that blanks should be run between each sample nnder investigation and check standards analysed as required by the quality assurance (QA) procedures in place in the laboratory. 

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