Rota 940 - Oq
Rota 940 - Oq
Rota 940 - Oq
PROTOCOL (OQ)”
ROTA 940 PA
AMPOULE FILLING & SEALING MACHINE (A3)
FOR
PHARCO PHARMACEUTICAL INDUSTRIES
ROTA 940 PA (A3) MACHINE OPERATION
QUALIFICATION PROTOCOL (OQ)
Al kawthar St., building 6.
PROTOCOL (OQ)
31st km Alex-Cairodesertroad. Customer: PHARCO
Al-Amriya, Alexandria,Egypt.
Protocol no. : A02-OQ041-2014 Pharmaceutical industries Co.
Tel/Fax: +2-03-4499924
Mob. : +20-12-22208383 Date of issue: 1-10-2014 Customer ID: A02
E-mail:Greentk.info@gmail.com
1- Protocol approval
1.1 Protocol Prepared By: -
2-Contents
1 Protocol approval 1
2 Contents 2
3 Introduction 3
4 Overview 4
4.1 Scope 4
4.2 Testing Philosophy 4
4.3 Equipment Identification 5
5 Responsibility 6
5.1 GREEN TK company 6
5.2 PHARCO company 6
6 Procedure 7
7 Performing calibration 9
8 Associated documents 10
9 Definitions of terms used in OQ test result sheet 11
10 Test plan 12
11 Test Protocol 13
12 Operational qualification tests 14
13 Job Sheets 35
14 Non-conforming report 36
15 Operation qualification summary report 37
16 Attachment 38
3. Introduction
It is necessary to verify that ROTA 940 PA (A3) conformance to specification in its intended
operational environment.
Has the ROTA 940 PA (A3) been built and configured to the agreed technical specification.
Does the ROTA 940 PA (A3) perform to the agreed functional specification?
Purpose:
This document sets out the operational qualification tests recommended by engineering deviation to
verify the conformity of ROTA 940 PA (A3) to approved technical specification. This plan is design to
guide operational qualification.
The document includes a total package, which may be used to plan, manage, conduct, and document the
operational qualification to the standard required by regulatory bodies.
4 .Overview:-
4.1 Scope: -
The document covers Operation Qualification of the specific SARONGMACHINE, at the production
area.
All components and sub systems of ROTA 940 PA (A3) are included if exceeded in full, a
comprehensive validation of the ROTA 940 PA (A3) can be achieved, as required after initial
commissioning.
4.2Testing Philosophy: -
No testing can be completely exhaustive. The objectives of the test plan is to-achieve a reasonable
level of assurance on every component and sub- system of the ROTA 940 PA (A3) while giving
Particular emphasis to Critical Process Parameters.
All tests are designed to verify the system against unambiguous, documented, pre-determined
acceptance criteria. The protocols are designed to ensure that the testing follows clear, pre-
determined methods approved in advance.
All tests are designed to be conducted by properly authorized personnel, supported by relevant
documentation and test equipment.
Wherever possible the tests are designed to collect all the documentary evidence needed to
retrospectively audit the validity of the results. The procedures call for the test results to be formally
reviewed before being regarded as finally accepted.
As the tests are designed to produce documentary evidence of the results, they can be witnessed at
the review stage. It is left to the discretion of the customer to decide whether to also have the testing
independently witnessed at the time of testing.
Machine S.N. 81
Model R 940 PA
Location Production
Department Ampoules
5:- Responsibilities
Present paragraph identify responsibilities of various parts involved in Qualification
activities.
(1) To manage the revision and the approval of the Qualification Protocol.
(2) To plan the execution of Qualification Protocol.
6-Procedure
6.1 Preparing a test plan:
The designated ""test manager"" must complete the test plan by:-
1) Identifying all aspects of the Operational Qualification to be covered.
2) Reviewing the verification tests included in this document and ensuring that all OQ
requirements have been included.
3) Designing any "additional" tests needed to meet any OQ requirements not covered by this
standard set of tests, which.
Identifying any tests, which are not required for this machine because they are "Not applicable" or
documentary evidence of conformance already.
A qualified "test approver" who must sign of each protocol sheet as it is approved must approve the
method and acceptance criteria of all protocol in the finalized test plan in advance.
The authorized tester using the method section of its protocol must conduct each test. Should
the method be unsuitable then a variation must be documented and authorized by the "test approver"
and the protocol conducted as an additional test. Each test protocol includes statement of the accepted
criteria that must be achieved for the test to be passed. This may the combined result of many test
steps.
The results must be recorded as required by the result section.
Where the result confirm that the expected result has been achieved, the results table will allow for a
clear statement (Yes / Not) of this.
YES will always confirm a satisfactory result
NO will always denote non-conformance
Where the method required the use of a calibrated measuring instrument, the unique identity of the
instrument used must be recorded in the instrument reference section of the protocol and the
reference of the calibration certificate recorded in the document or printout reference section.
When the result show that all acceptance criteria have been satisfied. The tester must indicate, writing
YES in the compliance section at the end of each form, then sign and date the section.
Should any acceptance criteria remain not satisfied, the tester must write NO in the compliance
section, sign it not initial the test plan, fill the protocol sheet in the failed tests, and advise the "test
manager" the problem must be resolved and the repeated on a new protocol sheet.
When each test has been satisfactory completed an authorized "test reviewer "must review the result
to verify that the test has been properly conducted by authorized personal, and signed off; all the
results are satisfactory; all the required supporting documentation has been identified, signed, dated
and retained. When satisfied that all is in order, the "test reviewer" must sign off the protocol sheet as
reviewed, file it in the reviewed tests, and initial the complete column in the test plan section 6.
When a test has been failed, the "test reviewer" must assess its results or a reviewer group called by
the "test manager".
Three actions are possible:
1) Repeat the test, using a new protocol sheet.
2) Apply a change or modification to the equipment and repeat the test.
3) Abandon the test, and possibly others.
The review shall decide which course of action to take, and in the event of a change or modification,
decide the amount of subsequent re-testing to be done.
The results of this review must be documented in a non-conforming report.
7- Performing calibration
8. Associated documents
The following documents have been used during preparation of the test result sheets:
• Wiring diagrams
• Layout
• Control Panel
• Operating manual
• Wiring diagram
Term Procedure
All main power switches of the machine are OFF.
Machine switched off
Additional switches for optional devices, e.g. a separate 24 V
power supply are also OFF.
Switch on machine Wait until the Touch Control has started up.
Reset faults
If the "test manager" assesses that earlier testing has given satisfactory evidence of functional
performance, he may choose to reduce or "Not required" the corresponding standard OQ test to be
done.
The tester must then initial each remaining test as it is completed with satisfactory result.
Pass/Fail
Expected Result 1 Machine is not running. Pass
2 Tension Pilot Lamp is extinguished Pass
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Machine cannot be started where
1 Pass
Expected Result ever you pressed
Mixing Stop Pilot Lamp is lighted
2 Pass
up
Prerequisites :
Test Procedure Machine ready for production
2 Start machine
Comment
Pass/Fail
Expected Result 1 Machine is not running Pass
2 All control panel items are off Pass
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Expected Result
1 Mixer rotation speed increased Pass
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Mixer is running until the mixing
1 Pass
timer countdown to (zero)
Expected Result
Mixing End Pilot Lamp will be
2 lighted up when mixer stopped Pass
after the operation ended
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Expected Result No powder will be conveyed due
1 to the opening of Butterfly valve Pass
gate
Some powder will be conveyed
2 and discharged through the Pass
Butterfly valve gate
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Prerequisites :
Test Procedure Machine ready for production
Comment
Pass/Fail
Prerequisites :
Test Procedure Machine ready for production
Disconnect the Mixer Interlock Sensor from the
1 main electricity panel
2 Press mixing on push button to start the mixer
Then press Mixing off push button to stop the
3
mixer
Comment
Pass/Fail
Expected Result
1 The machine running Pass
Prerequisites :
Test Procedure Machine ready for production
Disconnect the Positioning cam Proximity from
1 the main electricity panel
2 Press mixing on push button to start the mixer
Comment
The following tables list a series of possible faults which may be encountered
during normal machine operation.
After resetting any mechanical faults remember to press the RESET pushbutton
and check the list of messages on the machine display.
When carrying out operations within the machine ,always remember to exercise
extreme caution as regards the surrounding devices , so as to avoid injury to
persons or damage to the machine
Always ensure that all of the necessary checks or procedure have been completed
Person present
Name Signature Date
Follow up
Agreed corrective action
Date done backup evidence ref.
Qualification
Done by: Ahmed Bassiouny 25-9-2014
Engineer
Qualification
Reviewed by: Dina Rabea 25-9-2014
Engineer
Approved by:
16- Attachments
Qualification
Done by: Ahmed Bassiouny 25-9-2014
Engineer
Qualification
Reviewed by: Dina Rabea 25-9-2014
Engineer
Approved by: