SOP OF DRIED CAPSULE BULK PACKING

OBJECTIVE

To describe the procedures for dried bulk packing of soft gelatin capsules. 

2.0       SCOPE

This SOP is applicable for dried capsule bulk packing .

3.0       RESPONSIBILITY

            Production Chemist & operator      : To follow the procedure

4.0      ACCOUNTABILTY:

     QA & Head Production                  : For system compliance

•       PROCEDURE

         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.

6.0  TRAINING

Trainer   : Head Production Department

Trainees: Staff and machine operator of production and QA chemist.

                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

       REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.