Tag: iq oq

Integration of Route Qualification with QMS and CPV

Integration of Route Qualification with QMS and CPV Integration of Route Qualification with Quality Management Systems and Continuous Process Verification The pharmaceutical industry is under constant pressure to produce high-quality products while adhering to stringent regulatory requirements. This article serves…

Integrity Testing of Pre-Filled Syringes and Pen Injectors

Integrity Testing of Pre-Filled Syringes and Pen Injectors Integrity Testing of Pre-Filled Syringes and Pen Injectors Integrity Testing of Pre-Filled Syringes and Pen Injectors – Practical guide for pharma professionals on iq oq with GMP, FDA and EMA compliance. Step…

Sample HVAC Layout Plans for Grade A to D Areas

Sample HVAC Layout Plans for Grade A to D Areas Sample HVAC Layout Plans for Grade A to D Areas The design, validation, and continued assurance of HVAC systems used in pharmaceutical manufacturing are critical components in ensuring compliance with…

QA Review Criteria for Qualification Protocols

QA Review Criteria for Qualification Protocols QA Review Criteria for Qualification Protocols Qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), are crucial components in the validation lifecycle in pharmaceutical and biologics production. This guide provides…

VMP Templates and Checklists for Regulatory Audit Readiness

VMP Templates and Checklists for Regulatory Audit Readiness VMP Templates and Checklists for Regulatory Audit Readiness In the highly regulated pharmaceutical industry, the validation of processes plays a critical role in ensuring product quality, safety, and efficacy. Proper implementation of…

Training Your Team on GAMP 5 Principles and Practices

Training Your Team on GAMP 5 Principles and Practices Training Your Team on GAMP 5 Principles and Practices This article provides a comprehensive step-by-step guide for pharmaceutical professionals on the principles and practices of GAMP 5, specifically focusing on the…

Equipment Qualification vs Process Validation: Key Differences

Equipment Qualification vs Process Validation: Key Differences Equipment Qualification vs Process Validation: Key Differences Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first step in any validation lifecycle, particularly when it comes to equipment qualification (EQ) and…

Aligning R&D and QA During Early Process Design

Aligning R&D and QA During Early Process Design Aligning R&D and QA During Early Process Design In the pharmaceutical industry, the success of a drug development program is significantly tied to the alignment of Research and Development (R&D) and Quality…