Tag: cleaning validation in pharma industry

Writing a Water System IQ/OQ/PQ Protocol

Writing a Water System IQ/OQ/PQ Protocol Writing a Water System IQ/OQ/PQ Protocol Effective cleaning validation in the pharmaceutical industry is paramount to ensure product quality and patient safety. This step-by-step guide details the essential phases of writing an IQ/OQ/PQ protocol…

Documenting and Verifying Process Parameters in Validation Protocols

Documenting and Verifying Process Parameters in Validation Protocols Documenting and Verifying Process Parameters in Validation Protocols Step 1: User Requirement Specification (URS) and Risk Assessment The validation lifecycle commences with the establishment of a User Requirement Specification (URS). This document…

Role of Design of Experiments (DoE) in Determining CPPs

Role of Design of Experiments (DoE) in Determining CPPs Role of Design of Experiments (DoE) in Determining CPPs Cleaning validation in the pharma industry is a critical aspect of ensuring product safety and efficacy. With the strict regulatory requirements outlined…

How to Establish Control Limits for Key Manufacturing Parameters

How to Establish Control Limits for Key Manufacturing Parameters How to Establish Control Limits for Key Manufacturing Parameters Establishing control limits for key manufacturing parameters is a crucial aspect of process validation in the pharmaceutical industry. This article provides a…