Process Validation Protocol and Report

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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 reports to be drafted what are the contents and format of the protocol and report what are the requirements of the regulatory bodies this is what will be explored in this research study.

What is a Validation Protocol?

A Validation Protocol is an approved document which outlines the program to be employed, the tests that will be made and the acceptance criteria for those tests as part of the validation program.

Basically a validation protocol is a written document which describes what is to be accomplished during a validation program. Following are the basic requirements in the validation protocol

1. It should specify the data to be collected in the validation program.

2. The number of batches to be Included in the validation study.

3. How the data generated during the validation exercise, should be treated for relevance.

4. The Acceptance criteria for the results should be described.

5. The date of approval of the protocol by the validation organization should also be mentioned.

The basic advantages of having a validation protocol

a. Aids in controlling direction of the validation study

b. Provides control in the event of unanticipated developments during the validation study.

c. To trigger changes in the validation strategy if there is any unanticipated developments

d. A written validation protocol is also a basic requirement of regulatory agencies.

What is a Validation Report?

The validation report is a comprehensive summary that documents how the validation plan has been satisfied.

The validation report should document the detailed results of the validation effort, including test Results. Wherever possible, test results should be expressed in quantified form rather than expressed as “pass/fail.” The report should be reviewed and approved by designated Management or departments responsible for the validation more specifically validation team.

What constitutes a...
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