process performance qualification
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PQ Forum #21 - Validation Initiation Document Template

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Paul Pluta
Keyword(s):  
Pharmaceutical Manufacturing ◽  
Process Performance ◽  
Manufacturing Facility ◽  
External Review ◽  
Performance Qualification ◽  
Product Lifetime ◽  
Process Performance Qualification

Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance Qualification documents.

scholarly journals Stage 2 Process Performance Qualification (PPQ): a Scientific Approach to Determine the Number of PPQ Batches

2015 ◽  
Vol 17 (4) ◽  
pp. 829-833 ◽  
Author(s):  
Ajay Pazhayattil ◽  
Daniel Alsmeyer ◽  
Shu Chen ◽  
Maksuda Hye ◽  
Marzena Ingram ◽  
...  
Keyword(s):  
Process Performance ◽  
Performance Qualification ◽  
Scientific Approach ◽  
Process Performance Qualification

Scale-Up, Technology Transfer, and Process Performance Qualification

2013 ◽  
pp. 95-138
Author(s):  
Salah Ahmed ◽  
Ashok Katdare ◽  
Venkatesh Naini ◽  
Dilip Wadgaonkar
Keyword(s):  
Technology Transfer ◽  
Scale Up ◽  
Process Performance ◽  
Performance Qualification ◽  
Process Performance Qualification
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