Process Performance Qualification Protocol
Process Performance Qualification Protocol
Process Performance Qualification Protocol
Name of Product:
Stage:
Product Code:
Plant:
2. Scope
3. Approval Signatures
4. Responsibilities
5. Introduction
9. Reference Documents
14. Abbreviation
15. History
16. Annexures
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 :
Following personnels are responsible for preparation, review and approval of Process
Performance Qualification Protocol.
Reviewed By
Team Responsibility
Validation Dept. To develop necessary documents (Validation Master Plan, protocol, and
summery reports) guide and share responsibility of validation team along
with plant manager.
To provide training to concerns, to execute the protocols and monitor
validation efforts, to ensure completion of schedule.
To prepare summary reports for final management approval.
To get approval of all documents from the validation team members.
Engineer Projects/ To assist in supplying documents (procedure for equipment operation,
Maintenance data, manuals and drawings) necessary for execution of protocol.
To provide additional staff when needed to assist the inspection and
operation of an equipment and system.
To provide personnel when necessary to calibrate or check calibration
of measuring /recording & controlling instruments.
Calibration of instrument, incorporated into the system, prior to
validation.
Maintenance and calibration of validation equipment / instrument.
Storage and maintenance of the calibration documents.
Plant Manager To plan all the execution of validation programme.
To guide and supervise, the shift in charges and operators in
performing actual operation as described in SOP/BMR.
To check and record all the detailed observation and data collected by
shift supervisor.
To record the observation and deviation (if any).
Production In To actually perform / operate the equipment and equipment system as
Charge per SOP/ BMR.
To collect the necessary data and samples as described in the protocol.
To notice abnormality and deviation (if any), during the operation.
Quality Assurance To monitor & co-ordinate the whole validation program
To review all executed protocols.
To check / calculate / analyse various data collected during the
executive of protocol.
To maintain all the document related to the validation efforts.
Quality Unit To provide laboratory services for testing sample and provide test
results.
To collect the sample as per the procedure.
To assist validation team, by providing all related documents i.e. SOPs,
test procedure, BMR, sampling plan and validation / qualification
procedure.
To check, calculate and analyse various data collected during the
validation studies.
To maintain all the documents related to the validation studies for
review and presentation to the auditors / inspectors. (all original to be
maintained)
Brief description of Process, its stages and how many batches shall be produced with
respect to this protocol & their batch size.
Utilities:
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.
c) In Process Controls:
Note:
2 sets of samples shall be withdrawn, one for analysis & second for if any
abnormal results of first sample is observed.
Define the sampling locations diagram for Centrifuge, Dryer &/or Blender from which
samples for validations shall be withdrawn.
14.0 Abbreviations :
15.0 History :
16.0 Annexures :