Developing validating dissolution procedures Wecamchat online
With our global network of GMP compliant analytical laboratories in North America and Europe, our highly skilled scientists routinely conduct QC testing of raw materials, excipients, in-process samples and finished product batches.
GMP quality control (QC) testing programs for raw materials, APIs) and intermediates to pharmacopoeia specifications supported by troubleshooting and specialist QC methods Quality control testing of raw materials is needed from early stage product development through to commercial batch release.
The purpose of this article is to provide some insight into the development of dissolution tests for pharmaceutical dosage forms for several of the most frequent intents.
Because of the critical nature of the first two of these steps, dissolution testing is an economic and useful quality control tool to effectively assure acceptable product quality during different stages of the development and production of tablets, capsules and other solid dosage forms.The quality of raw materials can vary considerably from supplier to supplier, and even batch to batch, and so controlling the quality of the input material is key to the success of the product.The importance of knowing how to carry out process validation for a legacy product becomes especially evident when the product is transferred from one manufacturing site to another or, in some cases, when the product is sold from one company to another.There is a growing interest on the part of regulators to see ‘clinically relevant dissolution specifications’ , that is, specifications that can be linked to the performance of the drug product , but we have a long way to go in this arena.Method development and validation services compliment pharmacopoeial testing services should specialist QC methods be required.
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