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Process Performance Qualification Protocol

Name of Product:

Stage:

Product Code:

Plant:

Sr. No.	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
	10.1 Pre Qualification requirement
	10.2 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 :

Utilities:

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

  Note:

• 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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