Process Performance Qualification Protocol/Process Validation Protocol

Process Performance Qualification Protocol

Name of Product:


Product Code:


Table of Contents Page No.
1. Purpose  
2. Scope  
3. Approval Signatures  
4. Responsibilities  
5. Introduction  
6. Details of Raw Materials    
7. Details of Packing Materials  
8. Utilities & Equipment Qualification Details   
9. Reference Documents  
10. Process Performance Qualification Program  
Pre Qualification requirement
CPP, Non CPP & IP Controls
11. Sampling & Testing Plan  
12. Sampling Location Diagram  
13. Revalidation Criteria  
14. Abbreviation  
15. History  
16. Annexures  

1.0 Purpose :

The purpose of this Process Performance Qualification Protocol is to produce consistent quality of product by given sets of Equipments & Process Conditions by using Batch Manufacturing record (BMR).

2.0 Scope :

This Process Performance Qualification Protocol is applicable for the __________(Product Name / Stage), manufacturing at _________________(Plant Name / Company Name).

  • Batch Size:
  • Type of Validation : (Prospective /Retrospective / Concurrent)
  • Product Code :
  • Retest Period :

3.0 Approval Signatures:

Following personnels are responsible for preparation, review and approval of Process Performance Qualification Protocol.

4.0 Responsibilities :

The responsibilities and functions are as tabulated below.

5.0 Introduction :

  • Brief description of Process, its stages and how many batches shall be produced with respect to this protocol & their batch size.

6.0 Details of Raw Materials :

7.0 Details of Packing Materials :

8.0 Utilities & Equipment Qualification Details :


Equipment Qualification Details:

9.0 Reference Documents:

Mention list of following documents related with Product.

  • Batch manufacturing record:
  • Specifications :
  • SOPs :

10.0 Process Performance Qualification programme :

10.1 Pre qualification requirement:

The following pre qualification requirement shall be complied prior to execution of this protocol.

  • Verify that Validation master plan has been completed and approved.
    • Verify that the equipment qualifications (DQ, IQ, OQ) have been completed.
    • Verify that all equipment cleaning operations have been completed prior to the start of validation programme.
    • Process Flow Diagram

10.2 CPP, Non CPP & IP Controls :

a) Critical Process Parameters:

b) Non Critical Process Parameters:

c) In Process Controls:

11.0 Sampling & Testing Plan :

a) Centrifuge Process Validation :

  • Shall  be carried out for ensuring Homogeneity of Material
  • Samples shall be withdrawn from Top, Middle & Bottom of Centrifuge.

b) Drying Process Validation

  • Shall be carried out to ensure uniform drying of material across the dryer.
  • Samples shall be withdrawn from different locations as defined in Sampling location Diagram

c) Blending Process Validation

  • Shall be carried out to ensure uniform blending of material.
  • Samples shall be withdrawn from different locations as defined in Sampling location Diagram


  • Quantity of Validation Sample is approx. 10 gm 
  • 2 sets of samples shall be withdrawn, one for analysis & second for if any abnormal results of first sample is observed.
  • Withdraw equal amount of sample from different defined locations, mix well & treat that sample as “Composite Sample”
  • Sample shall be collected in fresh poly bag with self seal / lock.

12.0 Sampling Location Diagram :

  • Define the sampling locations diagram for Centrifuge, Dryer &/or Blender from which samples for validations shall be withdrawn.

13.0 Re-validation Criteria :

  • Change in process parameters
    • Change in the equipment and instruments type, specification design and MOC.
    • Change in the any major component of Equipment

14.0 Abbreviations :

  • BMR : Batch Manufacturing Record
  • SOP: Standard Operating Procedure.
  • MOC : Material of Construction
  • PPQP : Process Performance Qualification Protocol
  • History :

16.0 Annexures :

* Where XXX stands for the sequential no. for Protocol

               NN stands for revision no.

# Where F1 stands for Format No.

              AAA stands for Dept. Code

              BBB stands for SOP No.

              NN stands for revision no.

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