The Standard Operating Procedure of Maintaining Machine Usage Log is described in this post.
Maintaining Machine Usage Log OBJECTIVE
1.1 To lay down the procedure for maintaining machine or equipment usage log.
2.1 The scope of this SOP pertains to maintaining machine usage log of all machines or equipments placed in Production or Quality Area.
3.1 It is the responsibility of Operator and section Supervisor to follow this SOP as it is written.
3.2 It is the responsibility of Production Pharmacist, Quality Control Analyst and Quality Assurance Officer to ensure that this SOP is followed as it is written.
3.3 It is the responsibility of Production Manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary.
DEFINITIONS & ABBREVIATIONS
4.1 SOP: Standard Operating Procedure
MATERIALS & EQUIPMENTS
6.1 Write activities carried out for particular equipment in the log book assigned for that equipment in format on daily basis.
6.2 Operation carried out using this equipment giving reference to the batch number and name of the product for which the equipment has been used.
6.3 Mention duration (From… To) for which the equipment has been used.
6.4 Write maintenance (break down) work carried out on the equipment, if any.
6.5 Write remarks, if any.
6.6 Every activity entered is signed by production pharmacist, Quality Control Analyst, Quality Assurance Officer or Dispensing Pharmacist.
6.7 On completion /intermittently, the equipment log book is reviewed and cross checked by head of department.