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 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.
Purpose: The purpose is to describe the responsibility and functions of the validation team to meet the cGMP complianceResponsibility: It …
The Cleaning Validation Protocol is an essential part to execute the cleaning validation process. Title of Contents Objective Scope Responsibility …
Purpose: The goal of establishing Fundamentals of Validation SOPs is to help the parent business, affiliates, and contract manufacturers understand …
PURPOSE: This Master Validation Plan will give general guidelines for which modifications, additions, and reconstruction will be made in such …
Hold time is the period during which materials ( Machine Parts) may be held under specified conditions or time and …
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO …
There is often confusion surrounding the terms validation, calibration, and qualification within the pharmaceutical industry. Let’s explore their differences with …
After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery …
Autoclave validation is required to get effective Sterilization to ensure good product quality and also sterility of glassware and media used …
Validation of the water system is important in the pharmaceutical industry. Water is extensively used in the manufacturing process at …
Pharmaceutical products are generally contaminated by microorganisms, cleaning agents, or other materials, But in many cases, it may be due …
Validation is the established document evidence or proof that provides a high degree of assurance. A particular method can systematically …