To lay down the procedure for maintaining machine use log.
This SOP shall be applicable for maintaining machine use log of all production equipments in tablet and capsule manufacturing and packing areas.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
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 Log book has to review and cross check by head of department of production or designee.
5.7 These log books will be preserved for the period of four years for further reference.
6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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