by OBJECTIVE
To describe the procedures for inspection of soft gelatin capsules.
2.0 SCOPE
This SOP is applicable procedure for inspection of soft gelatin capsules.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
5.0 PROCEDURE
5.1 After unloading transfer the capsules to inspection area.
5.2 Check the bags with ‘In-process Label’ to be taken for Inspection as per SOP.
5.3 During inspection mention the party name, product name, batch no., mfg. date, exp. date, and
Batch size, date & shift and chemist’s name batch details on display board.
5.4 First switch ON the light of inspection table then fill un-inspected capsules in machine hopper And start the machine conveyor belt and start the inspection of capsules.
5.5 Following rejects shall be sorted out by comparing to the good capsules but not limited to: Under size capsules.
- Over size capsules
- Deshaped capsules
- Opaque capsules
- Leaked capsules
- Foreign particles on gelatin capsule shell
- Joint Capsules
- Air bubble in gelatin shell
- Different color shades
- Abnormal physical appearance
5.6 Defected capsules shall be collect in polybag and labeled as “Rejected Capsules”.
5.7 Collect the good capsules in Crate after inspection and status label pest on crate than transfer or Polishing in polishing area.
5.8 After complete inspection of batch rejected capsules collect and inter the details in BPCR and Capsules send for destroyed.
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
| Sr.No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
- 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 |
