Tag: FDA guidelines

Print Registration and Barcode Validation in Strip Packs

Print Registration and Barcode Validation in Strip Packs Print Registration and Barcode Validation in Strip Packs The validation of print registration and barcode systems in pharmaceutical strip packing is critical to ensure product integrity and compliance with regulatory requirements. This…

Using Quality Metrics to Drive Supplier Risk Re-Ranking

Using Quality Metrics to Drive Supplier Risk Re-Ranking Using Quality Metrics to Drive Supplier Risk Re-Ranking In the pharmaceutical industry, ensuring compliance with regulatory standards while maintaining product quality and safety is paramount. A critical part of achieving this involves…

Revalidation of Blister Machines After Change in Format

Revalidation of Blister Machines After Change in Format Revalidation of Blister Machines After Change in Format Revalidation of blister packaging machines is a critical process in ensuring the continued quality, safety, and efficacy of pharmaceutical products. With the continual evolution…

How to Set Up a Vendor Audit Calendar

How to Set Up a Vendor Audit Calendar How to Set Up a Vendor Audit Calendar Establishing a robust vendor audit calendar is crucial for ensuring quality and compliance in pharmaceutical operations. This article provides a comprehensive step-by-step validation tutorial…

Air Permeability and Leak Rate Acceptance Criteria

Air Permeability and Leak Rate Acceptance Criteria Air Permeability and Leak Rate Acceptance Criteria Air permeability and leak rate acceptance criteria are crucial aspects of pharmaceutical packaging validation processes. Appropriate evaluations and qualifications ensure that the packaging systems effectively protect…

Periodic Review and Requalification of Vendors and Materials

Periodic Review and Requalification of Vendors and Materials Periodic Review and Requalification of Vendors and Materials The effectiveness and reliability of the pharmaceutical manufacturing process are highly dependent on the quality of the vendors and materials used. Therefore, periodic review…

Common Blister Packaging Deviations and Their Root Causes

Common Blister Packaging Deviations and Their Root Causes Common Blister Packaging Deviations and Their Root Causes In the pharmaceutical industry, the validation of packaging systems is a critical component in ensuring product quality and regulatory compliance. Blister packaging, widely used…

Material Trending and Complaint Tracking by Vendor

Material Trending and Complaint Tracking by Vendor Material Trending and Complaint Tracking by Vendor In the pharmaceutical industry, the qualification of vendors and materials is a critical component of maintaining compliance with regulatory requirements and ensuring product quality. An effective…

How to Validate Pocket Integrity in Cold-Form Foil Blisters

How to Validate Pocket Integrity in Cold-Form Foil Blisters How to Validate Pocket Integrity in Cold-Form Foil Blisters Validation in the pharmaceutical industry is a critical requirement for ensuring that products meet their specifications and quality criteria. This article provides…

Vendor Scorecard Systems for Pharma Supplier Oversight

Vendor Scorecard Systems for Pharma Supplier Oversight Vendor Scorecard Systems for Pharma Supplier Oversight In the highly regulated pharmaceutical industry, ensuring the quality and reliability of suppliers is critical for maintaining compliance and product integrity. Implementing a robust vendor scorecard…