- OBJECTIVE
To lay down the Procedure for Cleaning and operation for Capsules Visual inspection Machine
2.0 SCOPE
This SOP is applicable to Cleaning and operation for Capsules Visual inspection.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
- PROCEDURE
- Cleaning
- Affix the status label “UNDER CLEANED” to the capsules inspection machine dully filled and signed by competent technical staff. Remove the capsules of the previous batch if remains.
- Remove the previous product identity from the capsules Inspection Machine.
- Clean the Capsule inspection machine with dry lint free cloth and moping with 70% IPA solution.
- Affix the status label “CLEANED” to the capsules Inspection Machine dully filled and signed by competent technical staff.
- Enter the cleaning record in respective Log Book
- Operation :
- Ensure the cleanliness of Capsules Visual inspection Machine and conveyor belt.
- Get the line clearance from IPQA chemist before starting the operation.
- Switch ON the Capsules visual inspection light.
- Switch ON the conveyor belt and set the speed of conveyor as per outlet speed of capsules.
- After completion of process switch OFF the Light and switch OFF the conveyor belt.
- Before beginning of activity and at the end of the day/shift activity clean the area.
- Cleaning
6.0 TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display copy : Production Department (If required)
8.0 ATTACHMENTS
Nil
- REFERENCES
In-house
10.0 ABBREVIATION
Abbreviation | Extended Form |
EG | Engineering |
SOP | Standard Operating Procedure |
QA | Quality Assurance |
WH | Warehouse |
NA | Not Applicable |
MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
Sr. No. | Date | Revision Details | Revision No. |
1 | NA | New SOP | 00 |