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Equipment Status log

Equipment Status log

OBJECTIVETo lay down a procedure of the maintenance of equipment sequential log.

SCOPE: This SOP is applicable to all equipment and machines of all manufacturing departments

RESPONSIBILITYProduction and Engineering officer/above shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITYConcerned Department Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

ATTACHMENTS:

Equipment Sequential Log

PROCEDURE :

Enter following information on the equipment sequential log.

Equipment Name:

ID No.:

Enter the date, product name and B.No., activity being performed in chronological order e.g. operation, cleaning, preventive maintenance etc.

Enter the time at which the activity commenced and was completed (write time in hours e.g. write 2 p.m. as 14:00 hours).

The operator performing activity must sign in the column of “Operator’s name” and “Cleaned by”.

The technical supervisor who checks the operation must sign in the column of “Checked by”.

Submit the filled equipment sequential logs to QA for storage, fill the Document requisition form for issuance of the new log book and forward it to QA.

All equipment sequential logs must be retained for 5 years.

Issuance and retrieval of equipment sequential logs is controlled by QA.

In the end of every calendar year all issued equipment sequential logs should be submitted to QA and new equipment sequential logs to be issued for the new calendar year.

REFERENCES:

In- House

ABBREVIATIONS:

QA     : Quality Assurance Department

B.No. : Batch number

DISTRIBUTION LIST :

Quality Assurance Department

Production Department

Engineering Department

HISTORY OF REVISION :

Version Number Effective Date Reason for Revision
00         – New SOP

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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