- 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 formulation plant.
- All the concerned personnel shall be responsible to follow the procedure for maintaining of equipment log book
- Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
- SOP : Standard Operating Procedure
- QA : Quality Assurance
- 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
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering
|Date||Revision Number||Reason for Revision|
Sequential Logbook for Equipment
|Batch No.||Batch Size||Operation Time||Cleaning
|Break Down/ Preventive maintenance||Done
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