Process Validation

Documentation Requirements for Process Range Justification

Documentation Requirements for Process Range Justification Documentation Requirements for Process Range Justification Process validation is integral to the pharmaceutical industry, ensuring that products meet predetermined specifications for quality, safety, and efficacy. This article serves as a comprehensive guide to understanding…

Out of Trend (OOT) Analysis and its Role in Process Capability

Out of Trend (OOT) Analysis and its Role in Process Capability Out of Trend (OOT) Analysis and its Role in Process Capability In the pharmaceutical industry, process validation is critical for ensuring product consistency and quality. Among the various facets…

Cross-functional Roles in Setting and Verifying Process Ranges

Cross-functional Roles in Setting and Verifying Process Ranges Cross-functional Roles in Setting and Verifying Process Ranges In the highly regulated pharmaceutical industry, ensuring process validation is a critical step in the lifecycle of drug development. The validation of processes not…

Aligning Equipment Qualification Data with Process Capability

Aligning Equipment Qualification Data with Process Capability Aligning Equipment Qualification Data with Process Capability Step 1: User Requirement Specification (URS) and Risk Assessment The initial step in the validation lifecycle involves defining the User Requirement Specification (URS), which documents the…

Challenges in Scaling Process Ranges from Pilot to Commercial Scale

Challenges in Scaling Process Ranges from Pilot to Commercial Scale Challenges in Scaling Process Ranges from Pilot to Commercial Scale In the pharmaceutical industry, the transition from pilot to commercial scale involves a multitude of validation steps that ensure processes…

Process Capability Case Studies in OSD and Sterile Manufacturing

Process Capability Case Studies in OSD and Sterile Manufacturing Process Capability Case Studies in OSD and Sterile Manufacturing Step 1: Define User Requirements and Conduct Risk Assessment The first step in the validation lifecycle is to establish the User Requirements…

Blend Uniformity in Solid Dosage Forms: Regulatory Expectations

Blend Uniformity in Solid Dosage Forms: Regulatory Expectations Blend Uniformity in Solid Dosage Forms: Regulatory Expectations In the pharmaceutical industry, ensuring blend uniformity in solid dosage forms is crucial for product efficacy and patient safety. This article serves as a…

How to Validate Powder Blend Homogeneity Effectively

How to Validate Powder Blend Homogeneity Effectively How to Validate Powder Blend Homogeneity Effectively Powder blend homogeneity is a critical aspect in the pharmaceutical manufacturing process, directly influencing the quality and efficacy of the final product. Validating the analytical procedures…

Acceptance Criteria for Blend Uniformity Testing

Acceptance Criteria for Blend Uniformity Testing Acceptance Criteria for Blend Uniformity Testing Blend uniformity testing is a pivotal aspect of the pharmaceutical manufacturing process, particularly within the context of regulatory compliance and quality assurance. Effective validation of blend uniformity assures…

Sampling Strategies for Assessing Blend Homogeneity

Sampling Strategies for Assessing Blend Homogeneity Sampling Strategies for Assessing Blend Homogeneity This article provides a comprehensive step-by-step tutorial on sampling strategies for assessing blend homogeneity in pharmaceutical processes, aligned with EU and US regulations including EU Annex 11. It…