Tag: FDA guidelines

Establishing Control Charts and Process Capability (Cp, Cpk)

Establishing Control Charts and Process Capability (Cp, Cpk) Establishing Control Charts and Process Capability (Cp, Cpk) In the pharmaceutical and biologics industries, demonstrating control over manufacturing processes is critical for ensuring product quality and compliance with regulatory expectations. One effective…

Risk Assessment for Minor vs Major Temperature Excursions

Risk Assessment for Minor vs Major Temperature Excursions Risk Assessment for Minor vs Major Temperature Excursions The pharmaceutical industry is bound by rigorous regulatory expectations concerning the integrity and efficacy of products during transport and storage. Effective system validation processes…

What Data to Monitor in CPV: CPPs, CQAs, and Beyond

What Data to Monitor in CPV: CPPs, CQAs, and Beyond What Data to Monitor in CPV: CPPs, CQAs, and Beyond In the pharmaceutical and biopharmaceutical industries, Continued Process Verification (CPV) has emerged as a critical component of the overall validation…

SOP Template: Deviation Handling During Product Transit

SOP Template: Deviation Handling During Product Transit SOP Template: Deviation Handling During Product Transit Transporting pharmaceutical products under controlled conditions is essential. This entails meticulous planning, risk assessment, and validation to comply with regulatory standards. The aim of this article…

Real-Time Monitoring and Its Impact on Lifecycle Verification

Real-Time Monitoring and Its Impact on Lifecycle Verification Real-Time Monitoring and Its Impact on Lifecycle Verification Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The first step in the validation lifecycle is developing a robust User Requirements Specification…

Root Cause Analysis for Cold Chain Deviations

Root Cause Analysis for Cold Chain Deviations Root Cause Analysis for Cold Chain Deviations In the pharmaceutical and biologics industries, maintaining the integrity of products throughout the cold chain is critical. Any deviation can lead to significant regulatory, financial, and…

QA Oversight in Reviewing CPV Strategy Across Lifecycle

QA Oversight in Reviewing CPV Strategy Across Lifecycle QA Oversight in Reviewing CPV Strategy Across Lifecycle In the ever-evolving landscape of pharmaceutical manufacturing, Continued Process Verification (CPV) serves as a key element in ensuring consistent product quality and compliance with…

How to Handle Temperature Excursions in Pharma Shipments

How to Handle Temperature Excursions in Pharma Shipments How to Handle Temperature Excursions in Pharma Shipments Step 1: Understanding Temperature Excursions and Regulatory Expectations Temperature excursions refer to deviations from the predefined temperature ranges that must be maintained during the…

Incorporating Feedback Loops from CPV to Process Design

Incorporating Feedback Loops from CPV to Process Design Incorporating Feedback Loops from CPV to Process Design In the pharmaceutical industry, the integration of Continued Process Verification (CPV) into the product and process validation lifecycle is paramount for ensuring product quality…

Data Integrity and Part 11 Compliance for Digital Devices

Data Integrity and Part 11 Compliance for Digital Devices Data Integrity and Part 11 Compliance for Digital Devices Ensuring compliance with regulatory standards for digital devices in the pharmaceutical industry is crucial for maintaining data integrity, particularly during sterilisation validation…