Tag: iso 11137 1

How to Present Excursion Data During a Regulatory Audit

How to Present Excursion Data During a Regulatory Audit How to Present Excursion Data During a Regulatory Audit Effective data presentation is essential during regulatory audits, particularly when dealing with excursions in cold chain management. This article serves as a…

Alignment with USP , ICH Q1A, and WHO TRS Guidelines

Alignment with USP, ICH Q1A, and WHO TRS Guidelines Alignment with USP, ICH Q1A, and WHO TRS Guidelines This article provides a comprehensive step-by-step validation tutorial specifically focused on ISO 11137-1, emphasizing the harmonization of medical device validation with relevant…

Validating Child-Resistant and Senior-Friendly Packaging

Validating Child-Resistant and Senior-Friendly Packaging Validating Child-Resistant and Senior-Friendly Packaging The validation of child-resistant and senior-friendly packaging is vital for safeguarding vulnerable populations while ensuring product integrity. Following the ISO 11137-1 guidelines and regulatory expectations from the FDA, EMA, and…

Drug-Container Interaction Testing and Leachable Assessment

Drug-Container Interaction Testing and Leachable Assessment Drug-Container Interaction Testing and Leachable Assessment In the pharmaceutical industry, ensuring the integrity and efficacy of drug products throughout their shelf life is paramount. A crucial aspect of this assurance lies in understanding the…

Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S

Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S Validation processes within the pharmaceutical industry are critical to ensuring compliance with regulatory requirements. HVAC (Heating, Ventilation, and Air Conditioning) systems play…

Linking HVAC Validation with Product Contamination Risk

Linking HVAC Validation with Product Contamination Risk Linking HVAC Validation with Product Contamination Risk In the pharmaceutical and medical device industries, the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems is crucial for ensuring product safety and quality. This…

Lifecycle Mapping for Validation Files in GxP Facilities

Lifecycle Mapping for Validation Files in GxP Facilities Lifecycle Mapping for Validation Files in GxP Facilities Validation in medical devices is critical to ensuring product quality and compliance with regulatory standards. This article provides a comprehensive step-by-step tutorial for the…

Electronic Document Management Systems (EDMS) in Pharma Validation

Electronic Document Management Systems (EDMS) in Pharma Validation Electronic Document Management Systems (EDMS) in Pharma Validation In the highly regulated pharmaceutical and medical device sectors, maintaining stringent validation practices is vital for ensuring product efficacy and patient safety. This article…

Using the VMP as a Validation Hub for New Product Launches

Using the VMP as a Validation Hub for New Product Launches Using the VMP as a Validation Hub for New Product Launches In the highly regulated pharmaceutical and medical device industries, effective validation processes are critical to ensuring product quality…

How to Use the VMP in Revalidation Strategy Planning

How to Use the VMP in Revalidation Strategy Planning How to Use the VMP in Revalidation Strategy Planning The pharmaceutical and medical device industries operate under strict regulatory frameworks that necessitate continuous compliance through structured validation processes. A Validation Master…