Pharmaceuticals process validation active pharmaceutical ingredients

The reasons behind the validation of cleaning procedures are the assurance of the safety and purity of the product (customer requirement), it is a regulatory requirement in active pharmaceutical ingredient product manufacture, and it assures the quality of the process from an internal control and comphance point of view... 

The validation process of a solid dosage form begins with a validation of the raw materials, both active pharmaceutical ingredients (APIs) and excipients [16-19],... 

It should be evident that concurrent validation is especially useful as a QA tool. This approach to validation is useful to QA because it enables QA to set its own objectives as criteria for PV. For example, QA seeks to have every process validated. Most pharmaceutical products contain one or two active ingredients. Process validation is very straightforward for them however, a whole new situation exists for a multivitamin/multimineral product. Innovative techniques are thus needed to achieve adequate validation. 

P. W. Wrezel, I. Chion, and M. S. Hussain, Validation and implementation of in-process control HPLC assays for active pharmaceutical ingredients, LC-GC North Am. 22 (2004), 1006-1009. 

The well-developed ways of validating R D, preclinical studies and clinical studies of active pharmaceutical ingredients (APIs) are applied with the appropriate modifications to the regulatory processes for small molecules, therapeutic proteins, proteins analogs, vectors for delivery and gene therapy, synthetic lipids, and other compounds derived from molecular biology. 

Compliance Policy Guide 7132c.08. Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. FDA. http //www.fda.gov/ora/compliance ref/cpg/ cpgdrg/cpg490-100. html. 

U.S. Food and Drug Administration (FDA) (2004, Mar.), Sec. 490.100 Process validation requirements for drug products and active Pharmaceutical ingredients subject to premarket approval (CPG 7132c.08), FDA, Rockville, MD. 

This chapter reviews the requirements of the U.S. Food and Drug Administration (FDA) for process validation of manufacturing pharmaceutical active ingredients (APIs) and inactive ingredients used in human and veterinary drug products. 

Process validation fundamentals are the same for processes that produce drug substances (active pharmaceutical ingredients) and those that produce drug products. 

---