SOP for the Preventive Maintenance of all Quality Control Instruments

Standard operating procedure for preventive maintenance of Quality Control Instruments.

1.0 OBJECTIVE

To lay down a procedure for the preventive maintenance of all quality control instruments which are having annual maintenance contract.

2.0 SCOPE

This procedure is applicable for the most sophisticated and costly equipment which can not be repaired/serviced within the factory premises by routine maintenance and Engineering department staff.

3.0 RESPONSIBILITY

3.1 Doing: Service engineer
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 List out the equipment to be covered under AMC.
5.2 After normal warranty period, communicate the company who supplied the said equipment to submit their proposal for Annual Maintenance Contract.
5.3 Evaluate the terms and conditions of contract and remuneration given by company and inform the company for personal discussion for any queries to be clarified.
5.4 On successful explanation for the queries raised from company, sign a contract for one year.
5.5 Maintain Instrument maintenance card to record the service undertaken and any parts, if changed.
5.6 Follow the preventive maintenance programme of instrument.
5.7 Carry out the preventive maintenance of instrument as per schedule agreed in AMC with respective party.
5.8 Renew the contract on same terms and conditions on yearly basis.

6.0 ABBREVIATIONS

6.1 Q.C= Quality control
6.2 A.M.C.= Annual maintenance contract
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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