Process Validation

Complete Guide to Process Validation in Pharmaceutical Manufacturing

Complete Guide to Process Validation in Pharmaceutical Manufacturing 1. Introduction to Process Validation Process validation is a critical and mandatory component of pharmaceutical manufacturing. It ensures that a manufacturing process consistently produces products that meet pre-established quality criteria. Defined by…

Designing Pharmaceutical Processes for Validation Readiness

Designing Pharmaceutical Processes for Validation Readiness How to Design Pharmaceutical Processes for Stage 1 Validation Readiness Stage 1 of process validation—Process Design—lays the scientific and regulatory foundation for the entire pharmaceutical manufacturing lifecycle. It precedes process qualification and continued verification,…

Process Qualification Protocols: Equipment, Utilities & Process Systems

Process Qualification Protocols: Equipment, Utilities & Process Systems Creating Process Qualification Protocols for Equipment, Utilities & Systems in Pharma Stage 2 of pharmaceutical process validation—Process Qualification (PQ)—is the critical phase where designed processes, equipment, and systems are tested under actual…

Real-Time Monitoring & CPV in Pharma: Tools, Trends & Compliance

Real-Time Monitoring & CPV in Pharma: Tools, Trends & Compliance Real-Time Monitoring & Continued Process Verification in Pharma: Tools, Trends & Compliance Guide Continued Process Verification (CPV), or Stage 3 of the process validation lifecycle, is a proactive, data-driven approach…

Validating Hold Times for Bulk and Intermediate Products in Pharma

Validating Hold Times for Bulk and Intermediate Products in Pharma Validating Hold Times for Bulk and Intermediate Pharmaceutical Products Holding time validation ensures that intermediate and bulk products remain within acceptable quality limits when stored before further processing or packaging.…

Identifying CPPs & CQAs: A Guide to Process Robustness in Pharma

Identifying CPPs & CQAs: A Guide to Process Robustness in Pharma A Complete Guide to Identifying CPPs and CQAs in Pharma for Robust Process Control Establishing a robust pharmaceutical manufacturing process requires clear identification of Critical Process Parameters (CPPs) and…

How to Design a Pharmaceutical Process: Step-by-Step Approach

How to Design a Pharmaceutical Process: Step-by-Step Approach How to Design a Pharmaceutical Process: Step-by-Step Approach Process validation is an essential aspect of pharmaceutical manufacturing that ensures processes are capable of consistently delivering products that meet quality standards. The validation…

Identifying Critical Quality Attributes (CQAs) and CPPs in Stage

Identifying Critical Quality Attributes (CQAs) and CPPs in Stage Identifying Critical Quality Attributes (CQAs) and CPPs in Stage In the highly regulated pharmaceutical industry, in-depth validation processes are essential for ensuring that products meet predefined quality standards. Understanding how to…

Process Design Phase Explained: Linking QbD to Validation

Process Design Phase Explained: Linking QbD to Validation Process Design Phase Explained: Linking QbD to Validation Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The User Requirements Specification (URS) is a critical element in the validation lifecycle. It…

Stage 1 Process Validation: Regulatory Expectations and Strategy

Stage 1 Process Validation: Regulatory Expectations and Strategy Stage 1 Process Validation: Regulatory Expectations and Strategy In the pharmaceutical and biologics sectors, achieving compliance with regulatory standards is crucial for ensuring product quality and safety. This article serves as a…