1.0 OBJECTIVE
To lay down the procedure for maintaining machine use log.2.0 SCOPE
This SOP shall be applicable for maintaining machine use log of all production equipments in tablet and capsule manufacturing and packing areas.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Write activities carried out for particular equipment in the logbook assigned for that equipment in format on daily basis.5.2 The activities will include:
5.2.1 Operation carried out using this equipment giving reference to the batch number and name of the product for which the equipment has been used.
5.2.2 Duration (From… To) for which the equipment has been used.
5.2.3 Maintenance (breakdown) work carried out on the equipment.
5.2.4 Equipment cleaning carried out.
5.2.5 Equipment cleaning (Type A) carried out after every maintenance (breakdown).
5.2.6 Remarks, if any.
5.3 Every activity entered shall be signed by department pharmacist.
5.4 QA person shall sign on the entries after verification of area and equipment cleaning as Type A, Type B, Type C as per the requirement.
5.5 Entries of maintenance (breakdown) work shall be mentioned in the Equipment Log Book.
5.6 On the completion/ intermittently the Equipment Logbook has to review and cross-check by the head of the department of production or designee.
5.7 These log books will be preserved for the period of four years for further reference.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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Dear Sir,
ReplyDeleteWe are using different logbooks (Equipment Logbook of Quality Control) but some have only "done by" option or only "checked by" option and some have both options. It's confusing. Is it required to have both "done by" and "checked by" option in Logbook?
Yes both are required.
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