Final Product Release Testing is a process that ensures that the final product of manufacturing process meets specific quality standards and regulatory requirements. This testing is typically performed at the end of the production process, after all of the necessary processing steps have been completed, and the product has been packaged and labeled for distribution.
During final chemical product release testing, various tests are performed to verify the chemical and physical properties of the product, such as purity, concentration, consistency, identity and safety. Typical testing would comprise of appearance, assay and impurities, dissolution and microbial testing. These tests may include analytical chemistry techniques such as chromatography, spectrophotometry, and titration. It is essential that the methodology involved is robust, to ensure the products’ safety and integrity, and reproducible, in order to minimise out-of-specification or out-of-trend repeats. The results of the final chemical product release testing are used to determine whether the product is suitable for release to the market or whether it needs to be further refined or modified to meet the required quality standards.
To help you demonstrate compliance with regulatory guidelines prior to releasing your biologics into global pharmaceutical markets, ALL Chemistry Inc. offers a wide range of GMP assays and testing services for your final product packages. ALL Chemistry Inc.’s extensive expertise in performing release testing includes API, drug product, medical devices and biologics. We have provision in place to handle highly potent and controlled substances.
Typical release testing methods include:
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U(H)PLC
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ID by NMR testing
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Residual solvent analysis
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Dissolution testing
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Moisture content analysis
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Method transfer
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Microbiology
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Clinical trial supply support
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Pharmacopoeial / Raw material analysis
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Reference standard management
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