Process Validation Protocol and Report
Process validation Protocol and Report
Chapter-1: Introduction
In today’s highly regulated environment for development and manufacturing of Pharmaceutical /biopharmaceutical Drugs and medical devices there is a heavy requirement imposed by the regulatory bodies, for the manufactures of drug products to provide an appropriate amount of assurance that critical processes employed in producing a drug substance or drug product can be shown to be both doing the right job, and doing the job right is often referred to as Validation.
FDA defines validation as. “Validation is a documented program which provides a high degree of assurance that a specific process will consistently and repeatedly produce a product meeting its predetermined specification and quality attributes.”-FDA
Validation is now considered as an essential part of GMP. Validation provides an approach to prove quality, functionality and performance of a pharmaceutical/biotechnological manufacturing process.
The validation approach can be applied to individual pieces of equipment as well as the manufacturing process as a whole. Guidelines for validation are set by the FDA, and other regulatory bodies but the specifics of validation are determined by the pharmaceutical/biotech company.
Equipment can very often be looked at as a process for the purpose of validation. At the very least, equipment is part of a larger process. The overall delineation of a company’s approach to the validation of its process and equipment is laid out in the Validation Plan. Validation has to be planned and carried out in an organized manner.
The entire process of validation revolves around central document i.e., process validation protocol as to here we define the how the validation is to be carried out, what are the plans to be followed how it should be documented i.e.; Written reports summarizing recorded results and conclusions should be prepared and stored(process validation report).
Then how this validation protocol and
Chapter-1: Introduction
In today’s highly regulated environment for development and manufacturing of Pharmaceutical /biopharmaceutical Drugs and medical devices there is a heavy requirement imposed by the regulatory bodies, for the manufactures of drug products to provide an appropriate amount of assurance that critical processes employed in producing a drug substance or drug product can be shown to be both doing the right job, and doing the job right is often referred to as Validation.
FDA defines validation as. “Validation is a documented program which provides a high degree of assurance that a specific process will consistently and repeatedly produce a product meeting its predetermined specification and quality attributes.”-FDA
Validation is now considered as an essential part of GMP. Validation provides an approach to prove quality, functionality and performance of a pharmaceutical/biotechnological manufacturing process.
The validation approach can be applied to individual pieces of equipment as well as the manufacturing process as a whole. Guidelines for validation are set by the FDA, and other regulatory bodies but the specifics of validation are determined by the pharmaceutical/biotech company.
Equipment can very often be looked at as a process for the purpose of validation. At the very least, equipment is part of a larger process. The overall delineation of a company’s approach to the validation of its process and equipment is laid out in the Validation Plan. Validation has to be planned and carried out in an organized manner.
The entire process of validation revolves around central document i.e., process validation protocol as to here we define the how the validation is to be carried out, what are the plans to be followed how it should be documented i.e.; Written reports summarizing recorded results and conclusions should be prepared and stored(process validation report).
Then how this validation protocol and