Tag: pharmaceutical validation

Using Real-Time Trackers vs Downloadable Data Loggers

Using Real-Time Trackers vs Downloadable Data Loggers Using Real-Time Trackers vs Downloadable Data Loggers In the pharmaceutical industry, the integrity of temperature-sensitive products during transport and storage is critical. With the introduction of various technology solutions, the choice between real-time…

Tamper Evident Seals and Security in Cold Chain Packaging

Tamper Evident Seals and Security in Cold Chain Packaging Tamper Evident Seals and Security in Cold Chain Packaging In the pharmaceutical industry, ensuring the integrity and security of products throughout the supply chain is paramount, particularly for temperature-sensitive medicines. This…

Impact of External Temperature on Packaging Performance

Impact of External Temperature on Packaging Performance Impact of External Temperature on Packaging Performance Ensuring that pharmaceutical products are transported and stored under appropriate temperature conditions is critical to maintaining their integrity and efficacy. An inadequately validated packaging system may…

Visual Inspection & Leak Test Parameters for Blister Packs

Visual Inspection & Leak Test Parameters for Blister Packs Visual Inspection & Leak Test Parameters for Blister Packs This detailed tutorial serves as a comprehensive guide for QA, QC, validation, and regulatory teams involved in the pharmaceutical validation of blister…

Dynamic Load Testing for Bulk Packaging Validation

Dynamic Load Testing for Bulk Packaging Validation Dynamic Load Testing for Bulk Packaging Validation In the pharmaceutical industry, robust validation processes are crucial to ensure product safety, quality, and compliance. This article provides a comprehensive step-by-step tutorial on dynamic load…

Case Study: Rejection Due to Label Mismatch on Shipper

Case Study: Rejection Due to Label Mismatch on Shipper Case Study: Rejection Due to Label Mismatch on Shipper In the highly regulated pharmaceutical industry, ensuring compliance with packaging standards is fundamental. This step-by-step tutorial provides an in-depth look at the…

Designing Environmental Monitoring Plans Based on HVAC Classification

Designing Environmental Monitoring Plans Based on HVAC Classification Designing Environmental Monitoring Plans Based on HVAC Classification Step 1: User Requirements Specification (URS) and Risk Assessment Before embarking on the validation lifecycle for designing environmental monitoring plans, it is imperative to…

Sampling Locations and Grading for PQ Testing

Sampling Locations and Grading for PQ Testing Sampling Locations and Grading for PQ Testing In the pharmaceutical industry, ensuring compliance with regulatory guidelines during HVAC system validation is fundamental for maintaining product quality and patient safety. This detailed step-by-step tutorial…

HVAC System Alarms and Interlocks: Verification Procedures

HVAC System Alarms and Interlocks: Verification Procedures HVAC System Alarms and Interlocks: Verification Procedures In the pharmaceutical industry, maintaining controlled environments is critical for the quality of products manufactured. HVAC systems play a vital role in achieving compliance with regulatory…

Trace Matrix Template for Equipment and Process Validation

Trace Matrix Template for Equipment and Process Validation Trace Matrix Template for Equipment and Process Validation In the pharmaceutical industry, the validation process is crucial to ensure product quality and compliance with regulatory standards. This article serves as a comprehensive…