Responsibilities of the Validation Team to Meet the cGMP Compliance
Purpose: The purpose is to describe the responsibility and functions of the validation team to meet the cGMP complianceResponsibility: It …
Validation
Validation is the documents evidence that involves every process with validation protocols. The Page will be updated with every change in GMP, pharma guideline and
regulatory requirements.
Cleaning Validation Protocol for Pharmaceutical Equipments
The Cleaning Validation Protocol is an essential part to execute the cleaning validation process. Title of Contents Objective Scope Responsibility …
Fundamentals of Validation SOP
Purpose: The goal of establishing Fundamentals of Validation SOPs is to help the parent business, affiliates, and contract manufacturers understand …
Facility Upgrade Master Validation Plan
PURPOSE: This Master Validation Plan will give general guidelines for which modifications, additions, and reconstruction will be made in such …
Protocol on Hold Time Study of Machine Parts
Hold time is the period during which materials ( Machine Parts) may be held under specified conditions or time and …
MACO and NOEL Calculation for cleaning Validation
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO …
Difference between Validation, Calibration, and Qualification in Pharma
Many of us have confusion between the terms validation, calibration, and qualification used in pharmaceutical industries. So let’s understand the …
Factory Acceptance Test (FAT) in Pharmaceutical
After completion of Design Qualification of new equipment generally, inspection is done by the user before the delivery at the site …
Autoclave Validation | Study on temperature Probes
Autoclave validation is required to get effective Sterilization to ensure good product quality and also sterility of glassware and media used …
Water System Validation and Phases
Water system validation is very important in pharmaceuticals. Water is used in the manufacturing process in very large quantities during different …
4 Types Process Validation in Pharmaceutical FDA 2023
Validation is the established document evidence or proof which provides a high degree of assurance, specific method can systematically manufacture …
