Important Update! PayPal Payment Now working for all International Users| Now Subscribe and Get Access to Dowload for all the Documents
logo
List of 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.