- OBJECTIVE :To lay down the procedure for Installation, Operation and Performance qualification of Equipment/Instrument.
- RESPONSIBILITY :
- Validation team comprising of representatives from functional department,Engineering department and Quality Assurance department.
- Head – QA, Head – Engineering and Head of the concerned department to ensure compliance.
- Any equipment or instrument purchased shall undergo installation and operational qualification based on its application.
- The validation team shall prepare the protocol for installation and operational qualification of the Instrument/Equipment with the guidance of the functional department head.
- The validation team shall prepare the protocol for performance qualification of process utilities whenever required and process equipments in Production.
- The head of the functional department shall arrange all the relevant information/documentation pertaining to each Instrument/Equipment from the manufacturer to support the validation document.
- The protocol for Installation Qualification and Operational Qualification shall be as per the general guidelines given in annexure -1 and annexure -2 respectively. The protocol for performance qualification will be specific for the system/ equipment to be validated as per general guidelines given in Annexure -3.
- Each protocol shall be identified with a number
- Generally Protocols shall be approved by Heads of QA, user department, and Engineering department or by their designee.
- The performer of the job shall sign with date the report after completion of each operation in checked by column.
- All the operations shall be verified by second person and sign with date in the verified by column.
- All the validation reports shall be certified by Heads of QA, User Department and Engineering department or by their designee.
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- DOCUMENTATION :
- The Validation protocol along with reports shall be kept in documentation cell
- Forms and Records (Annexures)
- PROCEDURE OF INSTALLATION QUALIFICATION – Annexure I
- PROCEDURE FOR OPERATIONAL QUALIFICATION -Annexure II
- PROCEDURE FOR PERFORMANCE QUALIFICATION -Annexure III
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control,Engineering & Warehouse
Reason for Revision
PROCEDURE OF INSTALLATION QUALIFICATION
- A typical equipment protocol for Installation Qualification shall be under various heads as described below.
- Objective :
- This section gives a brief overview of the objectives and procedures to be used for the Installation Qualification
- Equipment Description & Identification
- This section gives a brief description of the instrument/equipment. The details related to the identification of the instrument/equipment are also provided
- Equipment Masterfile
- Drawings/Manuals/List of spare parts
- This section shall provide a list of drawings, manuals and the list of spare parts for the equipment. The list of drawings includes detailed “AS BUILT” drawings,
- G.A drawings, schematic drawings of utilities and drawings of various components. The drawings shall be examined to ensure that they represent the actual installation. The location of these drawings, manuals, list of spare parts etc., will be noted
- Major Components
- This section identifies and provides the specifications for the major components of the instrument/equipment. These specifications shall be checked against the the “actuals” and signed. Any deviations observed shall be noted down under the head “comments”. The proper installation of these components shall be verified. The availability of specifications and test certificates of these components, if any shall be noted down under the head “Documentation”.
- Control System :
- This section is applicable for equipments/instruments with PLC based/SCADA based equipments
- This section identifies and provides the specifications for the Control system of the instrument/equipment. These specifications shall be checked against the “actuals” and signed. Any deviations observed shall be noted down under the head “comments”. The proper installation of these components shall be verified. The availability of specifications and test certificates of these components, if any shall be noted down under the head “Documentation”
- Material of Construction
- This section is required for the process equipments.
- This section identifies and provides the material of construction used for the contact as well as non-contact parts. The verification of the material of construction used is based on the test certificates and manufacturer’s specifications.
- Safety features and alarms
- This section shall list and verify all safety features and alarms installed.Each alarm and safety feature shall be listed individually.
- Utilities :
- This section shall list the specifications of the utilities installed. utility hook-up and the requirement of utilities of the equipment shall also be verified
- Standard Operating Procedures/Operating instructions/
- Preventive maintenance Procedures :
- This section shall identify and list all the Standard Operating Procedures (SOPs) /Operating Instructions (OIs) / Preventive Maintenance Procedures (PMPs) associated with the equipment/instrument
- Installation verification :
- This section shall provide a summarized verification to verify the proper installation of equipment/instrument as per the specifications of manufacturer. This section shall also provide a summary of critical specifications which are not included anywhere on the data sheets.
- Acceptance Criteria :
- This section shall provide an overview of all pertinent information and data required to qualify the installation of the equipment/instrument as acceptable.
PROCEDURE FOR OPERATIONAL QUALIFICATION
- A typical equipment protocol for Operational Qualification shall be under various heads as described below :
- Objective :
- This section will give a brief overview of the objectives of the Operational Qualification.
- Instrumentation Calibration
- This section shall list out all the critical and non-critical instruments of the equipment, wherever applicable.
- Calibration of all critical instruments shall be performed at the beginning and at the end of the Performance Qualification and verified.
- Non-critical instruments shall be calibrated during the operational qualification only.
- All calibration data will be recorded on calibration data sheets and attached to the validation document.
- Control Panel Testing :
- This section shall verify that all the keys/components/controls on the control panel functions as designated.
- ‘Method of testing’ and ‘Acceptance criteria’ to check each key/component/control on three different days shall be provided
- Safety features and alarms testing :
- This section shall verify that all safety features and alarms installed function when the required conditions are simulated. The testing of safety features and alarms shall be carried out on three different days
- SOP/OI/PMP Verification :
- The completeness and adequacy of all SOPs (associated with the instrument/ equipment listed out in Installation Qualification) shall be verified
- Operational Testing :
- This section generally provides various details like Purpose, Scope,Equipment used,Procedure, Documentation and Acceptance criteria of the individual tests to be performed. The data sheets and test results shall be attached to the validation document.
- Acceptance Criteria :
- This section shall verify the following :
- All acceptance criteria set forth in the Operational Qualification were met.
- All applicable data sheets are signed as checked and verified.
- Calibration of instrumentation is performed.
- All SOPs are verified for completeness and adequacy.
PROCEDURE FOR PERFORMANCE QUALIFICATION
- Objective :
- This section will give a brief overview of the objectives and procedures to be used for Performance Qualification
- Performance Qualification protocol :
- This section shall specify the Purpose, Scope, Equipment’s/Materials used,Procedure, Documentation and Acceptance Criteria.
- Protocol Execution :
- This section shall list out the personnel involved and deviations, if any during the execution of the Performance Qualification protocol
- Task Report :
- This section shall compile, analyse all the data generated out of the execution of Performance Qualification protocol. The data sheets, test results etc., shall be attached to the validation document
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube