Pharmaceutical testing and quality assurance are important in the pharmaceutical industry. The testing and analysis are carried out because people’s lives are dependent on the quality and quantity measure of a given medicine. Along with globalization, innovation gives rise to new pharmaceutical products which are safer and cost effective when they enter the market. The development of a pharmaceutical product or a drug requires a long period of time. The pharmaceutical product or a drug should receive approval from the U.S. Food and Drug Administration (FDA). The development process includes drug discovery, laboratory testing, animal studies, clinical trials, and regulatory registration.
A product or drug’s identity, strength, purity, quality, quantity, and stability are checked or tested before release for patient’s usage. Validation of testing methods assures that the analytical procedure used for a testing a specific product is right. It is used to identify the chemical composition and molecular structure of each individual content in a drug or product. Pharmaceutical testing conveys the solubility and the medication’s ability to reach a specified target within the body. Testing can identify contamination present in the manufacturing process. Granules should have proper balanced strength to withstand normal handling and mixing processes without deteriorating and producing large amounts of fine powder. Some size reduction during compaction into tablets is desirable to expose the areas of clean surface necessary for optimum bonding to take place so moisture content. This is an important factor for producing good pharmaceutical product.
Pharmaceutical validation includes assay validation, cleaning validation, used equipment validation including the stability analysis of the product, animal studies done for the product, and the beginning state of clinical development such as bioavailability or the bioequivalence studies. Pharmaceutical validation and the process used provide an assurance of uniformity and integrity of the batch of the manufactured product or drug.
The global pharmaceutical testing and analytical services market can be segmented based on product type, application, end-user, and region. In terms of product type, the global pharmaceutical testing and analytical services market can be classified into raw material testing, finished pharmaceutical product testing, in-process & product release testing, environment samples, and others. Raw material testing ensures that the raw materials used in pharmaceutical products are suitable for their intended use. Tests performed in a raw material laboratory are titration, loss-on drying, Karl Fischer moisture determination, heavy metals limit tests, and infrared spectrophotometry. The most used instruments in the testing process are pH meters, balances, gas chromatography, HPLCs, infrared spectrophotometry, UV spectrophotometers, Karl Fischer moisture titration, vacuum ovens, melting point apparatus, TLC, polarimeters, refractometers, viscometers, Muffles furnaces, flame atomic absorption spectrophotometers, elemental analyzers, differential scanning calorimeters, and thermogrvimetric analyzers. The function of in-process controls is to monitor, adopt the manufacturing process, control of equipment and environment. Based on the end user the global pharmaceutical testing and analytical services market is segmented into clinics, hospitals and others.
Geographically, the global pharmaceutical testing and analytical services market can be segmented into North America, Europe, Asia Pacific, Latin America and Middle East and Africa. Lack of skilled employees and underdeveloped health care infrastructure hampers the growth of the global pharmaceutical analytical testing services market. The operational costs, variations in good manufacturing practices, regulatory policies, and less time also restrain the pharmaceutical testing and analytical services market in Europe. The pharmaceutical testing and analytical services market in North America is expected to grow at a rapid pace due to well-developed outsourcing infrastructure.
Key players operating in the global pharmaceutical testing and analytical services market are Eurofins Scientific SE, Microbac Laboratories, ARL Bio Pharma, Inc., Envigo, Exova Group plc, PPD, Inc., DYNALABS, SGS, R.D. Laboratories, EAG, Inc., ADPEN Laboratories, Pace Analytical Services, Inc. among others.
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