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February 19, 2025

Standard Operating Procedure For Revalidation Procedure

Purpose: This document outlines the procedure for revalidating equipment, processes, and systems to ensure continued compliance with established standards and regulatory requirements. 1. Revalidation Categories 1.1. Process Revalidation: Generally, process revalidation (excluding sterile/aseptic processes) is not routinely performed. Validated status is maintained through the change control system. Revalidation outside of change control is considered only if there are repeated or […]

0 3 min read
February 16, 2025

Implementing CPPs and CQAs for Robust Vaccine Manufacturing

The production of high-quality vaccines hinges on the meticulous control of Critical Process Parameters (CPPs) and the rigorous monitoring of Critical Quality Attributes (CQAs). CPPs are the key variables within the manufacturing process that directly impact vaccine quality, while CQAs are the essential properties that must meet predefined limits to ensure safety and efficacy. The interplay between these two is […]

0 3 min read
February 15, 2025

Operational Qualification (OQ) vs. Performance Qualification (PQ) in Validation

In regulated industries like pharmaceuticals, medical devices, and biotechnology, validation is paramount. It’s the documented proof that a process, system, or piece of equipment consistently produces results meeting predetermined specifications and quality attributes. Within the broader validation lifecycle, two critical stages often cause confusion: Operational Qualification (OQ) and Performance Qualification (PQ). While both are essential for ensuring quality and compliance, […]

0 5 min read
February 7, 2025

Sampling in Pharmaceutical Manufacturing: Safety, Strategy, and Best Practices

Introduction Accurate and representative sampling is paramount in pharmaceutical manufacturing, impacting product quality, safety, and regulatory compliance. This critical process ensures that analyses performed on samples accurately reflect the entire batch or process, enabling informed decisions throughout the drug lifecycle. Effective sampling strategies encompass diverse techniques, from raw material inspection to finished product analysis, and must adhere to stringent Good […]

0 7 min read
January 23, 2025

Prospective Validation in Pharmaceutical Manufacturing: An In-Depth Guide

In the pharmaceutical industry, ensuring product quality, safety, and efficacy is paramount. One of the critical processes that play a significant role in achieving these goals is validation. Among the various types of validation, prospective validation holds a unique position as it is conducted before the commercial distribution of a product. This comprehensive guide explores the concept of prospective validation […]

0 4 min read
January 6, 2025

Out of specifications (OOS) in the Pharmaceutical Industry

In the pharmaceutical industry, Out of Specification (OOS) means a value that is either higher than or lower than a specified limit set under any regulatory documents, manufacturing procedure or quality control process. OOS results bring various consequences of poor product quality, imperiled patient safety, and noncompliance with regulatory requirements. For this reason, any form of OOS must be dealt […]

0 7 min read
December 31, 2024

Standard Operating Procedure SOP for Sampling in Process Validation.

1. Objective 1.1 The intention of this procedure is to facilitate the creation of best practices as to the right approach with regard to sampling during process validation. It embraces types of sample, sampling and sample collection, sample handling, analysis, documentation, and reporting that are critical in establishing product quality as well as compliance to regulatory requirements. 2. Scope 2.1 […]

0 3 min read