Tag: performance qualification

Stability Studies Supporting Packaging Validation

Stability Studies Supporting Packaging Validation Stability Studies Supporting Packaging Validation In the pharmaceutical and biologics sectors, implementing robust validation processes is fundamental to ensuring product quality, safety, and efficacy. One essential aspect of validation is the performance qualification of packaging…

Cold Chain Packaging System Validation for Secondary Packaging

Cold Chain Packaging System Validation for Secondary Packaging Cold Chain Packaging System Validation for Secondary Packaging In the pharmaceutical industry, the importance of validating cold chain packaging systems cannot be overstated. These systems ensure that temperature-sensitive products maintain their efficacy,…

Preparing HVAC Qualification Protocols: Template and Key Sections

Preparing HVAC Qualification Protocols: Template and Key Sections Preparing HVAC Qualification Protocols: Template and Key Sections Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the pharmaceutical industry, HVAC systems are critical for maintaining the necessary environmental conditions…

Documenting Deviations and Justifications in Final Reports

Documenting Deviations and Justifications in Final Reports Documenting Deviations and Justifications in Final Reports The pharmaceutical industry is anchored on stringent regulatory requirements ensuring the efficacy, safety, and quality of products. Within this framework, the importance of sound documentation practices…

Monitoring Progress of VMP Activities with KPIs

Monitoring Progress of VMP Activities with KPIs Monitoring Progress of VMP Activities with KPIs The validation master plan (VMP) serves as a critical framework for establishing and maintaining compliance in the pharmaceutical industry. One of the key components of a…

21 CFR Part 11 Checklist for Computer System Validation

21 CFR Part 11 Checklist for Computer System Validation 21 CFR Part 11 Checklist for Computer System Validation The validation lifecycle within the pharmaceutical industry is crucial to ensuring that processes and systems meet regulatory requirements and maintain quality standards.…

Dealing with Missing Calibration/Qualification History

Dealing with Missing Calibration/Qualification History Dealing with Missing Calibration/Qualification History In the pharmaceutical industry, validation activities are critical to ensure compliance with regulatory expectations and to maintain product quality. Missing calibration or qualification history for equipment can pose significant challenges…

Process Qualification Failure Handling and CAPA Strategies

Process Qualification Failure Handling and CAPA Strategies Process Qualification Failure Handling and CAPA Strategies In the complex landscape of pharmaceutical manufacturing, ensuring that processes are both validated and compliant with regulations is non-negotiable. This detailed guide focuses on the second…

Complete Guide to Process Validation in Pharmaceutical Manufacturing

Complete Guide to Process Validation in Pharmaceutical Manufacturing 1. Introduction to Process Validation Process validation is a critical and mandatory component of pharmaceutical manufacturing. It ensures that a manufacturing process consistently produces products that meet pre-established quality criteria. Defined by…