SOP Title: Start Up of Production Activity After Long Period
- Objective:
To define procedure for start up of production activity after long period.
- Scope:
This SOP is applicable to start up of production activities in Production Department, which is non-operational for a period of more than four weeks.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedure for in-process checks described in the SOP.
- Quality Assurance Department: To ensure the products meets the specification. To review and approve the SOP.
- Engineering Department: To perform the Preventive Maintenance and Calibration activity of the instruments.
- Accountability:
Head, Production Department. Head, QA Department.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
- Procedure
- Definition:
| Precautions: | ||
| 5.2.1 | Check the civil / electrical connection status of the area i.e. Flooring, ceiling, wiring, lighting, painting, etc. for its correctness. | |
| 5.2.2 | Check the status of all equipments and accessories for its smooth operation and safety of devices. | |
| 5.3 | Operation: | |
| 5.3.1 | Clean the area as per Sop “Cleaning and Sanitation of Production Area. | |
| 5.3.2 | Check the filters of Air Handling Unit visually for proper fitting, service lines of water, compressed air, steam and dust collection chamber. Clean as per their respective SOP. | |
| 5.3.3 | Clean all equipment and accessories as per respective SOP and get it certified by Quality Assurance. | |
| 5.3.4 | Fumigate the area as per SOP and sanitise the area using regular disinfectant solutions. | |
| 5.3.5 | After fumigation, environmental monitoring of the area should be done. | |
| 5.3.6 | Check visually the area cleanliness and equipment by taking rinse sample and get it certified by Quality Assurance. | |
| 5.3.7 | Calibrate the all equipment before use as per the respective SOP.
Record the cleaning, calibration and other environmental activity in the respective log / format. |
- Abbreviation:
| Abbreviation | Expansion |
| PD | Production Department |
| TAB | Tablet |
| % | Percent |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
*Note – Ready to use SOP available in “DOWNLOAD” Section.