Tag: Qualification of Vendors & Materials

Service Provider Qualification: What to Check and Document

Service Provider Qualification: What to Check and Document Service Provider Qualification: What to Check and Document Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of an effective validation process is the User Requirements Specification (URS), which…

How to Qualify Contract Laboratories for GMP Testing

How to Qualify Contract Laboratories for GMP Testing How to Qualify Contract Laboratories for GMP Testing Contract laboratories play a crucial role in the pharmaceutical industry, especially regarding Good Manufacturing Practice (GMP) compliance. The qualification of these laboratories is essential…

Material of Construction Certificates in Packaging Qualification

Material of Construction Certificates in Packaging Qualification Material of Construction Certificates in Packaging Qualification This article provides a comprehensive step-by-step guide for pharma professionals on the validation plan for software specifically related to Packaging Material Qualification. It addresses key considerations…

Qualification Report Format for Packaging Materials

Qualification Report Format for Packaging Materials Qualification Report Format for Packaging Materials Qualification of packaging materials is a critical aspect of pharmaceutical manufacturing and regulatory compliance. The use of electronic validation software such as ValGenesis, and adherence to guidance from…

Stability Impact of Packaging Material on Shelf Life

Stability Impact of Packaging Material on Shelf Life Stability Impact of Packaging Material on Shelf Life In today’s pharmaceutical landscape, the choice and validation of packaging materials is crucial in ensuring the stability and efficacy of products throughout their shelf…

Compatibility Studies Between Drug Product and Packaging

Compatibility Studies Between Drug Product and Packaging Compatibility Studies Between Drug Product and Packaging The pharmaceutical industry mandates stringent guidelines for ensuring the compatibility of drug products with their packaging. The significance of assessing this compatibility cannot be overstated, as…

How to Validate Barcode and Serialization Compliance

How to Validate Barcode and Serialization Compliance How to Validate Barcode and Serialization Compliance Validation in the pharmaceutical sector is a critical element to ensure that all processes yield products of the required quality, effectiveness, and safety. This article serves…

Managing Packaging Material Deviations and CAPAs

Managing Packaging Material Deviations and CAPAs Managing Packaging Material Deviations and CAPAs Effective management of packaging material deviations and corrective and preventive actions (CAPAs) is crucial for maintaining the quality and compliance of pharmaceutical products. This article provides a systematic…

Data Required for Packaging Material Specifications Approval

Data Required for Packaging Material Specifications Approval Data Required for Packaging Material Specifications Approval In the pharmaceutical and biologics sectors, ensuring the integrity and efficacy of packaging materials is essential for maintaining product quality and safety. This article provides a…

Sterile Packaging Qualification in Aseptic Environments

Sterile Packaging Qualification in Aseptic Environments Sterile Packaging Qualification in Aseptic Environments Sterile packaging qualification is a crucial aspect of ensuring the integrity of pharmaceutical products in aseptic environments. This comprehensive guide serves as a step-by-step tutorial on the validation…