Standard Operating Procedure of Installation Qualification (IQ) in pharmaceuticals is describe in this post.
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1. PURPOSE
This SOP describes a procedure to,
1.1 Ensure that the purchased Instrument / Equipment / System is correctly installed.
1.2 Conform and documents the information’s that the Instrument / Equipment / System installed, meets purchase / user specifications and the manufacturer literature.
2. SCOPE
2.1 Installation Qualification is performed after Design Qualification, Modification, or Re-location of any Instrument / Equipment / System in Production, Warehouse (RM/PM, FG), Q.C and Maintenance departments.
3. RESPONSIBILITY
3.1 If vendor performs the Installation Qualification then vendor may record the data on his own forms.
3.2 Head of Deptt. and Section Officer verifies the qualification and record.
3.3 Q.A Manager approves this Qualification and record.
3.4 Qualification Team comprises of concerned Section Officer, Head of Department, Maintenance department (where required), Executive Q.A Validation and Q.A Manager.
3.5 Head of Deptt, Section Officer, Executive Q.A Validation and Maintenance department (if required) supervises the study, verifies the completion of the records.
3.6 Section Officer writes the Deviation Report and Head of Deptt. verifies it.
3.7 Head of Deptt. and Section Officer firstly fill the Installation Qualification Protocol (Page # 1-7) and then complete Installation Qualification Report (Page # 8-16).
3.8 Executive Q.A Validation assists the concerned Deptt. in Installation Qualification study and reviews the Installation Qualification Protocol and Report.
3.9 Q.A Manager approves the Installation Qualification Protocol and Report.
4. MATERIAL & EQUIPMENT
4.1 Instrument/ Equipment/ System to be Qualified.
5. PROCEDURE
5.1 Installation Qualification Study have two portions,
5.1.1 PORTION-1
a. This portion is of Protocol (page # 1-7) and is completed (before start of IQ study) by Section Officer, HOD and Maintenance department (where required), reviewed by Executive Q.A Validation and sent to Q.A deptt. for approval by Q.A Manager.
5.1.2 PORTION-2
a. This portion is of Report (page # 8-16) and is completed during the IQ study.
5.2 Section Officer and HOD with the consultation of qualification team fill the protocol (pages 1-7) of Installation Qualification Protocol and send these pages to Q.A deptt. for approval.
5.3 Executive Q.A Validation gets its approval from Q.A. Manager, after thorough review and sends these pages back to section for performance.
5.4 Q.A assigns Installation Qualification (IQ) # to Instrument / Equipment / System from the Equipment Qualification Log Book and sends these pages back to section for performance; Serial # of IQ # is same as its Serial # in DQ #.
5.5 Objective and scope of performing Installation Qualification Activity and responsible persons for performing this activity are noted on Page 1 of Installation Qualification Protocol
5.6 General description of the Design, function, main components, Lubrication system (if any), safety features, environmental requirements and any required supporting utilities (piping, connections, electric / water supply etc.) of the Instrument / Equipment / System are noted down on Page 2 of Installation Qualification Protocol.
5.7 Information about Design, function, main components, environmental requirements etc., can be collected from Design Qualification Protocol.
5.8 A check list is prepared to check the items ordered / required (from Purchase Order) and actual received components and documents on Page 3 of Installation Qualification Protocol.
5.9 Actual Specifications of main components of Instrument / Equipment / System are compared with manufacturers’ Specifications on Page 4 of Installation Qualification Protocol.
5.10 Comparison of ordered / required spare parts and specifications with received spare parts and specifications, is made on Page 5 of Installation Qualification Protocol.
5.11 Comparison of item / part in product contact and material of construction is made on page 6 of Installation Qualification optional i.e., only for production equipments).
5.12 Recommendations by Manufacturer / In-house for Installation (if any) are given on page 7 of Installation Qualification Protocol.
5.13 Comparison of proposed and actual general description of the Design, function, main components and Lubrication system (if any) are noted down on page 8 of Installation Qualification Report.
5.14 Comparison of proposed and actual specification of item / parameter of any required supporting utilities (piping, connections, electric / water supply etc.) and safety feature of the Instrument / Equipment / System are noted down on Page 9 of Installation Qualification Report.
5.15 Comparison of items ordered / required (from Purchase Order) and actual received components with any deviation and documents are noted on Page 10 of Installation Qualification Report.
5.16 Comparison of Manufacturers / In-house specifications and Actual component function of main components of Instrument / Equipment / System with any deviation are made on Page 11 of Installation Qualification Report.
5.17 Any Deviation from Manufacturers / In-house recommendations during installation of Instrument / Equipment / System is noted on Page 12 of Installation Qualification Report.
5.18 Comparison of specifications of spare parts ordered / required and received with any deviation is made on page 13 of Installation Qualification Report.
5.19 Product contact surface area and material of construction of item / part is noted on page 14 of Installation Qualification Report (optional i.e., only for production equipments).
5.20 Deviation(s) during installation or deviation(s) of the Instrument / Equipment / System are explained in a Deviation Report on Page 15 of Installation Qualification Protocol along with justification of acceptance and their impact(s) on the operation.
5.21 Installation Qualification Report [Page 16 of Installation Qualification Report is prepared which includes,
5.20.1 Date study initiated and date study completed,
5.20.2 Major findings (main characteristics) regarding the Instrument / Equipment / System installed and recommendations (if any).
5.20.3 Brief explanation of deviations, their reasons and impact,
5.20.4 Location of relevant information and documents,
5.20.5 Instrument / Equipment / System added to Preventive Maintenance Program,
5.20.6 Conclusions on the completion of IQ (includes that Instrument / Equipment / System is correctly installed, meets specifications and Installation Qualification is completed).
5.21 After IQ completion whole Report is submitted to Q.A for approval.
5.22 After Q.A Manager approval of Installation Qualification Documents, IQ document approval date and relevant information’s are entered in the Equipment Qualification Log Book by Executive Q.A Validation.
5.23 After Successful completion of Installation Qualification a Label “Equipment Qualification” of that Instrument / Equipment / System is filled by Executive Q.A Validation and given to concerned department.
5.24 This Installation Qualification Report along with relevant documents is placed in the Instrument / Equipment / System Qualification file of respective Department in Q.A.
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