SOP on Maintaining of Equipment Log Book

SOP on Maintaining of Equipment Log Book

Objective: To lay down a procedure for maintaining of equipment log book.

Scope: This Standard Operating Procedure is applicable for maintaining of equipment log book associated with product (s) manufactured at the formulation plant.

Responsibility : All the concerned personnel shall be responsible for following the procedure for maintaining of equipment log book 

Accountability: The concerned Department Head and QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP : Standard Operating Procedure

QA   : Quality Assurance

Procedure

Concerned Departments should have Sequential Logbook for Equipment/Machine.

Details of operation, cleaning, preventive maintenance and breakdown shall be recorded in respective sequential log book.

Preparation, issuance, distribution & retrieval of sequential log book shall be controlled through QA Department.

On starting of every fiscal year QA shall issue sequential log book for every equipment to respective department upon receiving requisition for Sequential Logbook for Equipment / Machine.

Filled logbook shall be submitted to QA department.

If additional log book is required then concerned department shall raise the requisition for extra log book.

After QA Head approval, QA personnel shall issue the new log book to the concerned department.

Forms and Records (Annexures)

Sequential Logbook for Equipment   –   Annexure-I

Distribution

Master copy        –    Quality Assurance

Controlled copies –    Quality Assurance, Production, Quality Control, Stores, Engineering

History 

Date Revision Number Reason for Revision
00 New SOP

Annexure-I

Sequential Logbook for Equipment

 

Contents of Sequential Logbook for Equipment

  • S.No.
  • Date
  • Product Name
  • Batch No.
  • Batch Size
  • Cleaning Time
  • Break Down/ Preventive maintenance

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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