validation in pharmaceutics – Pharma Validation

Regulatory Expectations for Data Logger Use and Validation

Regulatory Expectations for Data Logger Use and Validation Regulatory Expectations for Data Logger Use and Validation Within the pharmaceutical and biologics industry, data loggers play a crucial role in ensuring the integrity and quality of temperature-sensitive products. As the industry…

WHO PQS Standards and Compliance for Packaging

WHO PQS Standards and Compliance for Packaging WHO PQS Standards and Compliance for Packaging Understanding validation in pharmaceutics is crucial for professionals involved in the pharmaceutical packaging process. The transition from traditional methods to modern validation practices necessitates a comprehensive…

Reusability and Cleaning Validation of Active Shippers

Reusability and Cleaning Validation of Active Shippers Reusability and Cleaning Validation of Active Shippers 1. Understanding User Requirements and Risk Assessment The initial phase of the validation lifecycle involves defining the user requirements specifications (URS) and conducting a comprehensive risk…

Common Blister Packaging Deviations and Their Root Causes

Common Blister Packaging Deviations and Their Root Causes Common Blister Packaging Deviations and Their Root Causes In the pharmaceutical industry, the validation of packaging systems is a critical component in ensuring product quality and regulatory compliance. Blister packaging, widely used…

Material Mix-Up Prevention Controls in Tertiary Packaging

Material Mix-Up Prevention Controls in Tertiary Packaging Material Mix-Up Prevention Controls in Tertiary Packaging In the realm of pharmaceuticals, ensuring the integrity and safety of products during packaging is paramount. The potential for material mix-ups in tertiary packaging can lead…

Role of QA in Verifying Outer Packaging GMP Compliance

Role of QA in Verifying Outer Packaging GMP Compliance Role of QA in Verifying Outer Packaging GMP Compliance Validation in pharmaceutics is critical for ensuring the safety, efficacy, and quality of pharmaceutical products throughout their lifecycle. This article provides a…

HVAC Alarm Triggers and EMS Data Correlation

HVAC Alarm Triggers and EMS Data Correlation HVAC Alarm Triggers and EMS Data Correlation Validation in pharmaceutics is a cornerstone for ensuring the quality and safety of pharmaceutical products. A robust validation framework is essential for demonstrating compliance with regulatory…

Equipment Used in HVAC Qualification and Calibration Requirements

Equipment Used in HVAC Qualification and Calibration Requirements Equipment Used in HVAC Qualification and Calibration Requirements In the pharmaceutical industry, effective HVAC systems play a critical role in maintaining the quality and safety of products. Given the stringent regulatory requirements,…

Balancing and Commissioning as Pre-requisite to Qualification

Balancing and Commissioning as Pre-requisite to Qualification Balancing and Commissioning as Pre-requisite to Qualification In the pharmaceutical industry, maintaining stringent quality assurance measures is pivotal. One of the crucial elements of quality assurance is the validation process. Validation in pharmaceutics…

How to Justify Deviations Using Traceable Data

How to Justify Deviations Using Traceable Data How to Justify Deviations Using Traceable Data In the pharmaceutical industry, maintaining compliance with regulatory guidelines and ensuring product quality are of utmost importance. One key aspect of this compliance is validation in…