Standard operating procedure for maintaining the usage and cleaning logbooks of the equipment.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for maintaining the equipment usage and cleaning logbooks.
2.0 Scope
This SOP is applicable for the procedure used for maintaining the usage and cleaning logbooks of equipment used in the production department.
3.0 Responsibility
3.1 Area supervisor is responsible for writing and maintaining the logbooks.
3.2 The production officer is responsible for implementing this SOP.
3.3 The production manager is responsible for ensuring the implementation of this SOP.
3.4 Q.A Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Logbook Format
4.1.1 A separate logbook in binding condition shall be used for writing the equipment usage and cleaning activity.
4.1.2 Loose pages in any format shall not be used as logbooks.
4.1.3 The format of the logbook shall include following options,
- Start Date
- End Date
- Product Name
- Start Time
- End Time
- Total Time
- Operator name
- Operator sign
- Pharmacist sign
- Remarks
- Revised by ( at end of the each page)
4.1.4 The first page of the logbook shall include following information
- Logbook Number
- Previous Logbook Number
- Upcoming Logbook Number
- Equipment Name
- Equipment ID
- Area supervisor
4.1.5 The total number of logbook pages shall be mentioned on footer of each page in following format
1/30,2/30,3/30,4/30……..till 30/30.
4.1.6 The logbook number shall be mentioned on the footer of every page of the logbook.
4.2 Equipment Usage Record
4.2.1 The entry of any activity performed on a specific equipment shall be recorded in the usage logbook of that equipment by the area supervisor.
4.2.2 The area supervisor shall enter the start date,start time and product name after starting the activity.
4.2.3 The area supervisor shall enter the end date,end time and total time at the end of activity performed on any equipment or machine.
4.2.4 The area super shall write the name of the operator and sign the logbook.
4.2.5 The production pharmacist cross checks the entries and signs the activity on the logbook.
4.2.6 Any type of breakdown shall also be mentioned in the equipment logbook in the remarks section.
4.3 Equipment Cleaning Logbook
4.3.1 The entry of any cleaning activity shall be mentioned in the cleaning logbook of that equipment.
4.3.2 The area supervisor shall record and sign the cleaning activity in the same manner as mentioned above.
4.3.3 Mention type A or type B cleaning in the remarks section.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA: Quality Assurance