To describe the procedures for dried bulk packing of soft gelatin capsules.
This SOP is applicable for dried capsule bulk packing .
Production Chemist & operator : To follow the procedure
QA & Head Production : For system compliance
Check and ensure the drying status of capsules from respective product batch manufacturing record.
Check and ensure that capsules are dried then proceed the bulk packing of dried capsules.
- Check the status label “CALIBRATED” of weighing balance.
- Weigh of 100 capsules and find out the average weight of capsules by dividing the
- observed weight of 100 capsules through 100.
- Weigh the total capsules and pack 10.00 kg capsules in each double plastic poly bags. If the capsules are remain less than 10.00 kg then pack it as such loose.
- Find out the total numbers of capsules by dividing the total weight of capsules through the average weight of a capsule.
- Affix the status label on each packed poly begs duly filled and signed by competent technical staff.
Trainer : Head Production Department
Trainees: Staff and machine operator of production and QA chemist.
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
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REVISION HISTORY OF CHANGE
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