02-SOP For Performance Qualifications

BIORISE PHARMACEUTICALS
Quality Assurance
Department SOP FOR PERFORMANCE QUALIFICATION
Document No: BRP/QA/GP/11/02 Issue/Revision #: 00
Issue Date: FEB-2022 Effective Date: Next Review Date: FEB-2025
1. PURPOSE
To outline a standard procedure for the preparation of performance qualification protocols.
To ensure that Performance Qualification (PQ) of all the facilities, equipment’s, utilities, manufacturing,
filling and packaging processes of the site which may impact product quality are carried out and
documented in accordance with this SOP.
2. SCOPE
This procedure is applicable for preparation of Performance Qualification protocols.
This SOP does not cover the PQ of analytical equipment’s and cleaning validation which are covered in
the separate SOPs.
3. ROLE AND RESPONSIBILITIES

 Preparation and/or checking of validation protocols.
 Monitoring the validation activities.
 Compilation of validation data.
Validation Coordinator
 Preparation and checking of validation report.
 Retaining of all master validation documents.
 Preparation / Checking of protocols.

 Preparation/ Checking of Validation reports.
Departmental Managers
 Investigating the Out of Specifications.
 Raising the deviation reports and investigating the root cause.
 Approval of Protocols.
Quality Head
 Prior approvals and release of Concurrent batches.
4. PROCEDURE
4.1 Introduction
Performance qualification (PQ) is defined as" a documented programme to demonstrate that an
operation (s), when carried out within defined parameters, will consistently perform its intended
function to meet pre-determined acceptance criteria."
Prepared By: Reviewed By: Approved By: Copy No.

Name: M. Farhan Name: M.Irfan Murtaza Name: M Naeem
Designation: Designation: Designation:
QA Officer Production Manager Manager QA & Quality Operations
Signature & date: Signature & date: Signature & date:
Page 1 of 7
Quality Assurance
Equipment, facilities or systems Performance Qualification is defined as documented evidence
that when operate within defined parameters, the equipment, facilities or systems will
consistently perform their intended function to meet pre-determined acceptance criteria"
4.2 Pre-Requisites
Before starting Performance Qualification, the following conditions must be satisfied:
i. DQ, IQ &OQ of facilities, services and process equipment including computerized
system must be documented.
ii. Product specifications and methods should be in place & Analytical method must be
validated.
iii. Authorized procedures must be in place for all relevant systems.
4.3 Performance Validation Preparation
Performance Qualification (PQ) typically will be identified through change control procedure, or as a part
of a major project to introduce a new equipment/product, change of site, change of formulation, and
change in batch size.
4.3.1 Requirements for Performance Qualification (PQ)
PQ is usually required:
i) Whenever a new process or item of equipment is introduced.
ii) If a change is made which has an actual or potential effect on the operating parameters of
an existing process, component or item of equipment.
iii) When moving an operation from one production line or equipment to another.
4.3.2 Defining the Equipment
i) The exact equipment to be used for PQ must be determined. Equipment should be identified
by its plant/equipment reference number or its specific name.
ii) Generally, PQ applies to new equipment where the process is product specific, hence testing
with live product is essential.
iii) Where testing may be non-product specific, for example, testing a bar code reader or
secondary packaging operations OQ testing is sufficient.
iv) In all cases where PQ involves changes in equipment it is advisable to define acceptance
criteria so as to differentiate equipment failures from process related failures.
v) All calibration routines must be in date throughout the period of PQ.

Page 2 of 7
Quality Assurance
vi) Utilities and facilities such as purified water and HVAC should be qualified or validated
before starting development work supporting PQ, and must be validated before running the
PQ batches.
4.3.3 Defining the Process
Before PQ can take place, a defined process must be available. This documentation will describe
the process, justify which of the process parameters are considered critical or non-critical, detail
the proven acceptable range for the critical parameters over which the validation exercise will be
performed and detail the operating range within these parameters including the settings to be used
for routine production. This detail will have been used to produce the batch manufacturing
records (BMR) and to update the SOPs. Initial training should take place at this time.
The use of the terms critical and non-critical is within the context of the process parameters or
steps being considered by the validation exercise. It is these critical parameters that are
challenged during Performance Qualification.
The minimum acceptable standard is to produce a minimum of three consecutive validation
batches, all of which must pass the acceptance criteria detailed in the PQ protocol for the
validation exercise to be considered complete and for routine production to be initiated.
4.3.4 Documentation
The PQ protocols will detail the concise method by which the PQ will be performed, the testing
program and the acceptance criteria which will demonstrate that the equipment is validated for
routine production use.
Batch Manufacturing Record (BMR) must be produced for new/change process.
4.3.5 Sampling Plans
Samples should be of an appropriate size and taken at a sufficient rate and tested to give a high
level of assurance that the whole batch will comply with its specification.
4.3.6 Matrix
Where identical items of equipment exist within a department it may be possible to reduce the
number of validation batches by looking at the total validation across the lines and producing
matrix approach.
4.3.7 PQ Protocol
Validation protocols are documents, which detail the tests to be performed, and the acceptance
criteria for these tests. They are written and approved before the validation activity takes place.
i). Contents
Page 3 of 7
Quality Assurance
Each protocol will typically contain as a minimum:
 Objectives.
 Introduction - a description of the task to be achieved,
 Rationale
 Scope
 Item or parameter to be tested.
 The purpose of the testing.
 Reference to supporting documentation, i.e. VMP, SVMP
 Reference SOP, mentioning the number of this SOP for developing the protocol.
 Method - details of the tests to be performed and how the of these will be reported.
 Acceptance criteria for each test.
Where the protocol has several pages, each page should be numbered and the protocol
identity referenced on each page in the header except first page.
ii). Document Reference Number
Reference Number on Validation Protocols will be assigned as mentioned here under:
VP/BRP/ x1/ x2/ x3/ x4 where
VP stands for Validation Protocol
BRP representing the company
1
x consist of 3-4 letters showing equipment name i.e. SUS for Suspensions,
COMP for Tablets compression, CAP for Capsules filling machine etc
x2 consist of 2-3 letter showing type of validation activity i.e. MFG for
Manufacturing, EQP for Equipment etc
3
x consist of 3 numeric showing unique sequence number e.g. 001
x4 consist of 2 numeric showing version number e.g. 01
For example, reference number for the validation of tablets press machine would be
VP/BRP/COMP/EQP/001/01.
The numbering system should be controlled by Validation Coordinator. A typical format
of PQ protocol is attached in Appendix-I.
iii). Recording and Analysis of PQ Results
On completion of the PQ batch, PQ Reports formats should be completed and passed to
the Quality Control department for final checking.
The batch records, in-process and laboratory test results will be checked and signed by
Quality Manager or his designate to ensure that the batches were manufactured, sampled
and tested as per PQ protocols and that the PQ acceptance criteria have been achieved.
Page 4 of 7
Quality Assurance
iv). Failures and Deviations
Any test failures during PQ must be formally investigated to identify the cause of failure.
Once the cause of the PQ failure has been identified the validation team must agree into
which of the two main categories of failure it falls.
Type 1: Where the failure can be attributed to an occurrence which is not intrinsic to the
equipment, for example, a faulty raw material, then it can be agreed to complete the
validation exercise substituting another trial batch for the one that failed. This
investigation and the subsequent action should be included in the PQ report and VSR.
Type 2: Where the failure may be attributed to a equipment failure or where the
investigation is inconclusive then the validation exercise has failed.
In this case the validation team should decide and justify the course of action to be taken,
recording its justification and recommendations.
v). Validation Report

After the completion of PQ exercise, validation coordinator will review the validation
exercise against the requirements of PQ protocol and summarize the findings.
The VR should contain the following contents:
 Reference to the SVMP and PQ protocol
 Validation batch numbers and dates.
 Details of the results obtained
 Details of any deviations
 Details of any acceptance criteria not met and actions taken
 OOS investigations and deviation reports raised for the batches, including an
assessment of the impact of the deviation on the validity of the exercise.
VR should be signed by the validation coordinator, Department manager, Quality Head
and Plant Director.
vi). Validation Summary Report

Quality Head must control the release of PQ batches to ensure that these cannot be
released until the validation exercise is successfully completed and the validation
summary report is issued.

Page 5 of 7
Quality Assurance
Concurrent validation i.e. batch-by-batch release must only be used where justified &
validation batches can be released on receiving a copy of the prior approval from Quality
Head.
Any decision to release batches prior to the completion of a validation exercise must be
approved/authorized by the Quality Head.
5. APPENDICES
Appendix-I Format for Performance Qualification Protocol for Equipment / Machine.
6. REFERRENCE DOCUMENTS
PIC/S Guidelines, PI 006-3
ICH Guidelines
Appendix – I
PERFORMANCE QUALIFICATION PROTOCOL

FOR
MACHINE / FACILITY
Approval and Authorisation

Completion of the following signature blocks signifies the understanding and agreement with the contents of this
document.
PREPARED BY
Name Designation Signature Date
CHECKED BY
APPROVED BY
AUTHORIZED BY
NOTE: Reference No. of Protocol will be shown in the header of each page except first one and Number
of this SOP will be shown in the Reference SOP section.

Page 6 of 7
Quality Assurance
7.0 REPORTING DOCUMENTS

Appendix I
8.0 LIST OF RECIPIENTS

Issued on Withdrawn on
Recipients
(Signature / Date) (Signature / Date)
QA Manager
QC Manager
Production Manager
9.0 CHANGE HISTORY:
Whenever revise the SOP then this portion need to be filled.
CHANGE HISTORY
VERSION No. CCR No. REVISION DETAILS
00 - First Version

Page 7 of 7

02-SOP For Performance Qualifications

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

02-SOP For Performance Qualifications

Uploaded by

Copyright:

Available Formats

BIORISE PHARMACEUTICALS

3. ROLE AND RESPONSIBILITIES

 Preparation / Checking of protocols.

Prepared By: Reviewed By: Approved By: Copy No.

Prepared By: Reviewed By: Approved By: Copy No.

v). Validation Report

vi). Validation Summary Report

Prepared By: Reviewed By: Approved By: Copy No.

PERFORMANCE QUALIFICATION PROTOCOL

Approval and Authorisation

Prepared By: Reviewed By: Approved By: Copy No.

7.0 REPORTING DOCUMENTS

8.0 LIST OF RECIPIENTS

VERSION No. CCR No. REVISION DETAILS

Prepared By: Reviewed By: Approved By: Copy No.

You might also like