Process Performance Qualification and Validation of Prazosin Hydrochloride Capsules USP 1 mg Manufactured at Commercial Scale

Abstract

Background: Process validation is an important part of pharmaceutical quality assurance that gives documented proof of consistency of the manufacturing process in terms of production of products meeting certain pre-defined quality standards. Process Performance Qualification (PPQ) is carried out to confirm reproducibility of the process in commercial scale manufacture.
Objectives: To validate the process of manufacturing of Prazosin Hydrochloride Capsules USP 1 mg by means of PPQ studies. To examine CPPs and CQAs in three consecutive commercial scale batches.
Methods: Three consecutive PPQ batches of Prazosin Hydrochloride Capsules USP 1 mg were manufactured using validated process. Critical stages of the process were controlled, and the samples were subjected to tests for appearance, assay, content uniformity, dissolution, moisture content and microbial limits in accordance with approved specifications.
Results: All three validation batches met pre-defined acceptance criteria. CPPs did not exceed the specified limits during the process. The testing of finished products confirmed their consistent quality, uniformity and appropriate dissolution profile.
Conclusion: The PPQ study proved to be successful in demonstrating that the process of manufacturing of Prazosin Hydrochloride Capsules USP 1 mg is capable of consistently producing the product meeting pre-defined quality requirements.