Tag: pharmaceutical process validation

Integrating Validation Docs with LIMS, QMS, and ERP Systems

Integrating Validation Docs with LIMS, QMS, and ERP Systems Integrating Validation Docs with LIMS, QMS, and ERP Systems In the pharmaceutical industry, effective documentation is crucial for ensuring compliance with regulatory frameworks. The process of pharmaceutical process validation (PPV) involves…

Handling Obsolete Validation Protocols and Reports

Handling Obsolete Validation Protocols and Reports Handling Obsolete Validation Protocols and Reports In the pharmaceutical industry, regulatory compliance and validation are crucial to ensuring that processes meet the highest quality standards. Obsolete validation protocols and reports can pose significant risks.…

VMP Alignment with ICH Q8, Q9, and Q10 Guidelines

VMP Alignment with ICH Q8, Q9, and Q10 Guidelines VMP Alignment with ICH Q8, Q9, and Q10 Guidelines Validation Master Plans (VMP) are a critical document within the pharmaceutical industry, particularly as they foster compliance with global regulatory standards and…

Case Study: Lifecycle-Based VMP Implementation at a Global Plant

Case Study: Lifecycle-Based VMP Implementation at a Global Plant Case Study: Lifecycle-Based VMP Implementation at a Global Plant The validation lifecycle in the pharmaceutical industry is essential for ensuring that processes, systems, and equipment meet their intended use while complying…

Connecting the DQ/IQ/OQ/PQ Matrix to the VMP

Connecting the DQ/IQ/OQ/PQ Matrix to the VMP Connecting the DQ/IQ/OQ/PQ Matrix to the VMP In the pharmaceutical industry, ensuring quality and compliance with stringent regulatory standards is fundamental. Pharmaceutical process validation is a structured approach that guarantees the reliability and…

Validating Disaster Recovery for Cloud Platforms

Validating Disaster Recovery for Cloud Platforms Validating Disaster Recovery for Cloud Platforms In the contemporary landscape of the pharmaceutical industry, the utilization of cloud platforms has surged, leading to the imperative necessity for a robust disaster recovery (DR) validation framework.…

Cloud CSV Audit Checklist: What Regulators Expect

Cloud CSV Audit Checklist: What Regulators Expect Cloud CSV Audit Checklist: What Regulators Expect In the complex landscape of pharmaceutical manufacturing and the ever-expanding role of cloud computing, effective validation becomes paramount. This comprehensive guide aims to provide a step-by-step…

SOP Template for Cloud-Based System Lifecycle Management

SOP Template for Cloud-Based System Lifecycle Management SOP Template for Cloud-Based System Lifecycle Management In the highly regulated pharmaceutical industry, adhering to stringent guidelines is paramount. This comprehensive tutorial on pharmaceutical process validation (PPV) serves as a guide to help…

FAT and SAT Reports for Equipment Transferred Between Plants

FAT and SAT Reports for Equipment Transferred Between Plants FAT and SAT Reports for Equipment Transferred Between Plants Ensuring that equipment performs reliably and remains compliant with regulatory standards during a tech transfer is a critical aspect of pharmaceutical process…

Site vs Global Qualification Standards: Alignment Strategies

Site vs Global Qualification Standards: Alignment Strategies Site vs Global Qualification Standards: Alignment Strategies In the world of pharmaceutical development, ensuring the compliance and efficacy of processes through systematic validation is of paramount importance. As companies scale their operations and…