The pharmaceutical market is a heavily regulated, highly competitive environment where a small drop in manufacturing cost can mean the difference between profit and loss, long-term sustainability in business between failure and a lack of survival. Increasing prices of raw materials, compliance regulations, labor, energy and equipment maintenance-related costs continue to wreak havoc on global pha…
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Installation Qualification (IQ) in Pharmaceuticals
The qualification of equipment in pharmaceutical manufacturing is not simply a compliance requirement. But it is part of the scientific process utilized to ensure that the equipment, utilities or systems will continue to perform as expected. The qualification process consists of several phases.
Design Qualification (DQ) in Pharmaceuticals
Equipment, systems, and components used throughout the pharmaceutical manufacturing process are essential to ensuring the safety, quality and regulatory compliance of products manufactured. Before installation and qualification of any equipment, it must be demonstrated that it is designed for its designated purpose and is compliant with regulations of GMP.
Quality Risk Management (QRM) in Pharmaceuticals
To guarantee that their products are safe, effective, and of the best quality before being distributed to patients, the pharmaceutical industry is highly regulated by government organizations, which means that compliance alone does not provide confidence; instead, a durable and proactive methodology for risk identification, analysis and control must be used to ensure a sufficient level of confide…
How to Write a Validation Protocol?
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
How to Effectively Execute a Validation Protocol?
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
How to Write a Factory Acceptance Test FAT Protocol
Factory Acceptance Test (FAT) is done at the equipment manufacturing site of the vendor before the shipping. A proper FAT can help to minimize the problems occur during the installation of the equipment at the site. A FAT protocol can be written as follows.
Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals
1.0 OBJECTIVE1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment.
2.0 SCOPE2.1 This procedure applies to all aseptically filled sterile products intended for human use.
3.0 RESPONSIBILITY3.1 The Validation personnel coordinate the aseptic filling validation program …
2.0 SCOPE2.1 This procedure applies to all aseptically filled sterile products intended for human use.
3.0 RESPONSIBILITY3.1 The Validation personnel coordinate the aseptic filling validation program …
Cleaning Method Validation Protocol for Pharmaceutical Equipments
Objective: The purpose of the study is to validate the analytical method for determination of traces of API contents in Swab & Rinse samples and to establish documented evidence and provide the procedure for the same.
Cleaning Validation Sample Protocol
CLEANING VALIDATION PROTOCOL Product : Protocol No.: Revision No.: Page No….of …..
1. Introduction
One equipment used at one stage, manufacturing of different products is very common in pharmaceuticals manufacturing. After use, the equipment is cleaned to prevent cross-contamination of drug products.
The efficacy of cleaning procedure should be such that it effectively removes traces of the previous p…
The efficacy of cleaning procedure should be such that it effectively removes traces of the previous p…
