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XYZ
FACILITY
protocol preparation
NAME AND TITLE SIGNATURE DATE
(mm/dd/yy) PREPARED BY:
QPS, LLC Michael Molloy, PE
Consultant
the signatures below indicate approval of this operational protocol. once the signatures are obtained, execution of the protocol may begin.
protocol approval
NAME AND TITLE SIGNATURE DATE
(mm/dd/yy) APPROVED BY:
XYZ Engineering
Facilities Manger APPROVED BY:
XYZ Production Production Manager APPROVED BY:
XYZ Quality Assurance
Quality Assurance
TABLE OF CONTENTS
1.0 Purpose 3
2.0 Scope 3
3.0 Equipment Description 3
4.0 Responsibilities 3
5.0 Reference Documents 4
6.0 Definitions 4
7.0 Materials and Equipment 4
8.0 Test Function Number One: OQ Signature Verification List (Attachment #1) 4
9.0 Test Function Number Two: Procedure List (Attachment #2) 5
10.0 Test Function Number Three: Training Verification (Attachment #3) 5
11.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4) 5
12.0 Test Function Number Five: Functional Verification (Attachment #6) 6
13.0 Deviation Reporting Log (Attachment #10) 6
14.0 Operational Qualification Protocol Review (Attachment #11) 7
15.0 Summary Report Requirements 7
Purpose
The objective of this protocol is to verify that the Raw Materials Sampling Tent consisting of the components described in Section 3.0, operate in accordance to manufacturers’ specifications, and in accordance with Current Good Manufacturing Practices (cGMP’s).
(1) – 99”W x 99”D x 110”H Softwall clean room (Model ______ Serial______)
(2) – 23-5/8”W x 47-5/8”D x 13-1/2”H Motorized HEPA filter modules (Model ______ Serial ______)
Scope
This Operational Qualification Protocol pertains to the verification of the operation of the equipment described in Section 3.0 of this protocol, and installed in the XYZ COMPANY, ROCKVILLE, MD. This protocol is specific to the Raw Materials Sampling Tent, and related instrumentation and equipment, and does not address facility, or facility related equipme
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