Sources of quality variation in pharmaceutical industry
Quality control of pharmaceutical formulations is an essential operation in the production of drugs. It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications. This requires organization and strict quality checks at each level of production. Show
Quality control is concerned with both quality and quantity. The quality of pharmaceutical dosages forms must be built in during plant construction, product research and development, purchasing of materials, production, testing, inspection, packaging, labelling, storage, and distribution. It cannot be assumed that finished product testing alone will ensure product quality. This article provides an overview of quality control requirements for dosage forms and the types of tests needed for their evaluation. Contents
Good Manufacturing PracticeGood Manufacturing Practice (GMP) is a requirement that drugs and methods used in or the facilities or controls used in their manufacture, processing, handling or packaging conform with those practices that will assure that such drugs meet the quality standards appropriate to their intended use and as required by the marketing authorization. These regulations concern themselves with specific criteria for buildings, equipment, personnel, components, master formula and batch production records, production and control procedures, product containers, packaging and labelling, laboratory controls, distribution records, stability and complaint files. Quality Assurance (QA)Quality assurance is the totality of arrangements made with aim of ensuring that pharmaceutical products are of the quality required for their intended use. This includes all that influences the quality of the product. QA = QC + GMP QuarantineThe status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing. Common sources of quality variationWhen the quality of any drug is given by an industry, then it is responsible for any variation from the standard. Variation in quality may occur due to any mistake during the whole process, that is from the reception of the raw materials up to the finished product in packed form. Risk of error increases as the materials increases and the method becomes more complicated. Sources of product quality variation during manufacture are: Materials
Machines
Men
Methods
Milieu (Environment or Premises)This is the fifth source of quality variation. The environment must be clean, dust- free, spacious and properly designed to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination. It must be suitable for the purpose for which it is to be used. Quality control requirements for oral solid dosage forms (Tablets, Capsules, Powders)
Sterility and apyrogenicity tests are essential additional tests for powdered materials for injection. Quality Control requirements for semi-solid dosage forms (Ointments, Creams, Jellies and Suppositories)Tests include:
Quality control requirements for liquid preparationsTests include:
For liquid products to be used as injections, eye drops or vaccines sterility, apyrogenicity test and particulate matter testing are necessary as additional tests. ConclusionThe quality of pharmaceutical dosage forms is essential to minimize or eliminate the risk of marketing unsafe products. In order to guarantee quality and consistency of drugs batch to batch, all operations involved in the manufacture of dosage forms, from receipt of raw materials, through processing, packaging and repackaging, labelling and re-labelling, completion of the finished products, to distribution should be controlled. References
Related keywords: quality control of pharmaceutical dosage forms pdf, quality control tests for pharmaceutical dosage forms ppt, quality control test for semisolid dosage form, quality control of drugs pdf, in process quality control test slideshare, quality assurance What are the different sources of quality variation?Sources of variation, its measurement and control. Measurement error (reliability and validity) ... . Random error (chance) ... . Systematic error (bias) ... . Misclassification (Information bias). What is quality variation in pharmaceutical industry?SORCES OF QUALITY VARIATIONS Quality Variation: When the quality of any drug is given by industry, then it is responsible for any variation from the standard. Quality Variation may occurdue to any mistake during the whole process i.e. from the reception of raw material up to the final productin the packaged form.
What is quality variation?Quality Glossary Definition: Variation. The Law of Variation is defined as the difference between an ideal and an actual situation. Variation or variability is most often encountered as a change in data, expected outcomes, or slight changes in production quality.
What are the causes of variation in quality explain the objectives of quality control?Causes of Variation in Quality
Common cause (noise) variations: inherent in a process over time and affecting all outcomes. Special cause (signal) variations: unusual circumstances not inherent in a process. Tampering: when attempts to reduce variation increase variation instead.
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