Process Validation Protocols

1.0 OBJECTIVE

The objective of this Process Performance Qualification (PPQ) Report is to summarize the activities completed to confirm that the manufacturing process of “Product Name with Strength (AAAADDDD CCmg)” is capable of consistently delivering product that meets the requirements of the Quality Target Product Profile (QTPP), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Finished Product Specifications. This PPQ report evaluates the three (03) batches manufactured as per approved Batch manufacturing record ZZZZZZ/XXX/DDD-VV and approved PPQ Protocol Number:  XXX/YYYY/ZZZZ (Version No.: 00).

2.0 SCOPE

This PPQ Report summarizes the results and conclusions of the batches manufactured as per approved Batch manufacturing record ZZZZZZ/XXX/DDD-VV and approved PPQ Protocol Number XXX/YYYY/ZZZZ  Version No.: 00. Data obtained from this PPQ exercise will be used to update the commercial manufacturing documents of product “Product Name With Strength (AAAADDDD CCmg)” as per recommendations of PPQ study.

3.0 BACKGROUND

Process Performance Qualification of product Name With Strength (AAAADDDD CCmg) has been initiated due to product commercialization in USA market as per change control number CC/ZZZ/AAAA Three consecutive batches of batch size XXXXX Tablets were manufactured as per approved Batch manufacturing Record Number ZZZZZZ/XXX/DDD-VV.

The Process Performance Qualification report is prepared to compile and evaluate the process parameter data, in-process observations and analytical results to demonstrate that the manufacturing process is suitable for consistently producing the product meeting its pre-determined specifications and quality attributes.

1.0 OBJECTIVE

To establish documented evidence to provide a high degree of assurance that the manufacturing process of ‘Product Name with Strength (ABCD EF mg)’ will consistently produce the product meeting its pre-determined specifications and quality attribute.

2.0 SCOPE

This protocol is applicable to Process Performance Qualification Batches of “Product Name with Strength (ABCD EF mg)” to be manufactured as per approved Batch Manufacturing Record number- XXXXYYYYZZZZ for XYZ market with a batch size of  (XXXXXX Nos. Tablets). Reference approved change control number is XXXXXXXXXXXXXXXXXXX.

3.0 INTRODUCTION

Add the Background behind the development of product that required validation discuss the scaleup and exhibit and optimization batch and recommendation also give the details of change control reference.

At least three (03) consecutive process performance qualification batches of the drug product shall be manufactured as per approved master batch manufacturing record and shall be tested as per approved standard testing procedure to demonstrate compliance with the approved specifications.

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1.0 Objective

To lay down a procedure to be followed for Continued Process Verification by Statistical Evaluation of data, collected from manufacturing and analysis of product Name of Study Product to establish document evidence to provide a high degree of assurance that the process remains in a state of control (in validated state) during commercial manufacture of product Name of Study Product.

2.0 Scope

This continued process verification protocol is applicable for Continuous Monitoring of Manufacturing Process by the Statistical Evaluation of identified CPPs and CQAs for products Name of Study Product manufactured at Name the Facility/Site.

The Scope of this protocol will also to address:

• Collection and evaluation of information and data about the performance of the process, which allows detection of undesired process variability.

• Evaluating the performance of the process, identifies problems and determines whether action must be taken to correct, anticipate and prevent problems so that the process remains in control.

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1.0 Objective

The objective of this Continued Process Verification Report is to summarize the Statistical Evaluation of data collected from manufacturing and analysis of product Name of Study Product, for establish document evidence to provide a high degree of assurance that the process remains in a state of control (in validated state) during commercial manufacture of product Name of Study Product.

2.0 Scope

This continued process verification Report is applicable for Continuous Monitoring of Manufacturing Process by the Statistical Evaluation of identified CPPs and CQAs for products Name of Study Product manufactured at Name the facility.

The Scope of this report is limited to below listed batches

List of Batch Number which is under evaluation

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