Tag: iso 14644 1

Risk-Based Approach to Transport Qualification in Pharma

Risk-Based Approach to Transport Qualification in Pharma Risk-Based Approach to Transport Qualification in Pharma The pharmaceutical industry must adhere to strict regulatory guidelines to ensure that products are consistently produced and controlled according to quality standards. One crucial aspect of…

Extractables and Leachables Testing for Primary Containers

Extractables and Leachables Testing for Primary Containers Extractables and Leachables Testing for Primary Containers Extractables and Leachables (E&L) testing is critical in ensuring the safety and efficacy of pharmaceutical products packaged in primary containers. The reliable assessment of E&L helps…

Components of a Pharmaceutical HVAC System and Their Functions

Components of a Pharmaceutical HVAC System and Their Functions Components of a Pharmaceutical HVAC System and Their Functions This article serves as a comprehensive guide for pharmaceutical professionals focusing on the validation lifecycle of HVAC systems within pharmaceutical manufacturing environments.…

Linking User Requirements to DQ, IQ, OQ, PQ Documentation

Linking User Requirements to DQ, IQ, OQ, PQ Documentation Linking User Requirements to DQ, IQ, OQ, PQ Documentation In the pharmaceutical industry, establishing a robust validation framework is crucial for ensuring product quality and compliance with regulatory requirements. This article…

Cross-Referencing SOPs and Protocols in Your VMP

Cross-Referencing SOPs and Protocols in Your VMP Cross-Referencing SOPs and Protocols in Your VMP In the pharmaceutical industry, ensuring compliance with regulatory standards is paramount for maintaining the integrity and quality of products. A Validation Master Plan (VMP) serves as…

Leveraging GAMP 5 in Small and Mid-Sized Pharma Facilities

Leveraging GAMP 5 in Small and Mid-Sized Pharma Facilities Leveraging GAMP 5 in Small and Mid-Sized Pharma Facilities In the highly regulated environment of pharmaceutical production, compliance with Good Manufacturing Practice (GMP), particularly in the context of computer system validation…

Operational Qualification: What Parameters to Verify

Operational Qualification: What Parameters to Verify Operational Qualification: What Parameters to Verify Step 1: Understanding the URS & Risk Assessment Operational Qualification (OQ) is an integral part of the validation lifecycle in the pharmaceutical industry, ensuring that equipment operates within…

Using DOE in Stage 1 Validation for Robust Process Design

Using DOE in Stage 1 Validation for Robust Process Design Using DOE in Stage 1 Validation for Robust Process Design Stage 1 of the validation lifecycle is crucial for establishing a foundation for robust process design in the pharmaceutical industry.…