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SOP on Handling of PLC System Failure

  • Objective:To lay down the procedure for Handling of PLC System Failure.
  • Scope:This standard operating procedure is applicable for all PLC system’s installed in formulation plant of Pharmaceutical company name with location.
  • Responsibility
    • Production Supervisor / Officer shall be responsible for implementation of this SOP.
    • Engineering personnel shall be responsible for handling and repairing the PLC system hardware
    • Head-Production/ Designee shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP – Standard Operating Procedure

QA – Quality Assurance

S.S.- Stainless steel

PLC – Programmable logical controller

HDPE – High density polyethylene

MMI –  Man Machine Interface

  • Procedure
    • In case of PLC/MMI Software/Hardware failure condition, production department shall intimate to Engineering department for the corrective action through Maintenance work order.
    • After receiving the Maintenance work order, Production shall handover the equipment for further action.
    • Engineering Department shall take following action.
      • Engineering department shall have  PLC hardware system in spare or purchase new as per specification
      • Keep application software / source code backup for all PLC system with application name, software version and store in control area in two different locations.
      • Restore by either external agency or vendor service engineer.
      • Production, Engineering and QA person shall take the trial for the operation of the equipment and revalidate the equipment and control system.
      • If operation of equipment found satisfactory, then engineering department shall hand over the equipment to production department.

Precaution:-During the maintenance work all the material shall be taken out and covered properly in HDPE or S.S container with a “CONTAINER LABEL” affixed on it.

  • Forms and Records

Not Applicable

  • Distributions
    • Master Copy – Documentation Cell (QA)
    • Controlled Copies – Production, Engineering and Quality Assurance
  • History
Date Revision

Number

Reason for revision
00 New SOP

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About Pharmaceutical Guidanace

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

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