A Computer System Validation (CSV) Master Plan is a high-level document that defines the overall approach, strategy, and methodology for validating computer systems in a pharmaceutical or GMP-regulated environment. It ensures that all computerized systems are fit for their intended…
Computer System Validation (CSV) of QC Instruments in Pharma is a structured process used to ensure that computer-based systems (like analytical instruments with software) perform reliably and accurately, complying with regulatory standards such as 21 CFR Part 11, Annex 11,…
A Project Validation Plan (PVP) for Quality Control (QC) facilities outlines the structured approach to ensure that the QC facilities comply with regulatory standards, operate as intended, and meet the requirements for testing pharmaceutical products. A Project Validation Plan (PVP)…
Occupational Exposure Level (OEL) is the maximum airborne concentration of a substance (usually an API or potent intermediate) that workers can be exposed to, safely, during their normal working day. In simple terms, OEL tells you “how much is too…
Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various scientific disciplines, including pharmaceuticals, environmental monitoring, food and beverage testing, and clinical diagnostics. This process ensures that the…
Transport validation is a Good Distribution Practice (GDP) requirement. It ensures that pharmaceutical products are consistently transported under conditions that maintain their quality, safety, and efficacy. Below is an overview you can use for training, audits, or procedure writing: 🚚…
✅ What is ERP Validation? ERP (Enterprise Resource Planning) Validation means providing documented evidence that the ERP system: 🎯 Why is ERP Validation Important? 🛠️ Key Components of ERP Validation Component Details User Requirements (URS) Define what the system must…
A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. Dry Powder Injection Three Piece Injection Ampoules Liquid Vials
During Hold Time Study in Pharma, Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk, and finished products are stored under appropriate conditions. Storage arrangements should…
Microbiological Validations and Qualifications in Pharma Microbiological validations and qualifications in pharma ensure that manufacturing processes, cleanrooms, equipment, and testing methods consistently control microbial contamination. These activities are essential for GMP compliance, patient safety, and reliable product quality—especially for sterile…
Cleaning Validation in Pharma – Step-by-Step Guide Cleaning Validation is a documented proof that a cleaning procedure consistently removes residues of previous products, cleaning agents and microorganisms to a pre-defined, acceptable level. In the pharmaceutical industry, cleaning validation is critical…
In the pharmaceutical sector, CSV is crucial for enhancing product quality, improving process performance, and supporting high-quality goods. The primary advantage of the CSV is providing quality controls, which help to prevent manual error and ensure that the process is…