SOP FOR BOTTLE PACKING

  1. OBJECTIVE

           To lay down the Procedure for bottle packing.

2.0     SCOPE

         This SOP is applicable for bottle packing.

3.0    RESPONSIBILITY

         Production Chemist & operator      : To follow the procedure

4.0    ACCOUNTABILTY

          QA & Head Production                  : For system compliance

  •     PROCEDURE
    •  Bottle Filling
      • Ensure the bottle filling area should be clean before the start of bottle filling.
      • Take the line clearance by IPQA Officer.   
      • Received the dispensed quantity of bottle after cleaning on the presence of IPQA & Production department.
      • Received the capsules from quarantine on the presence of IPQA & Production department.
      • Ensure the bottle filling person wear proper Cap, nose mask, gloves & Gowning.
      • Count the capsules by capsules counter/Manually and fill in cleaned bottle.
      • And put the silica gel in the filled bottle if recommended.
    • Bottle Sealing
      • After filling of capsules in bottle affix induction seal in bottle cap and closed the bottle cap and seal the bottle through induction sealing machine by pressing the induction heat bottom on filled bottle cap upto 0.5 to 0.8 seconds.
    • Labeling of bottle
      • After filling and sealing the bottle transfer the bottle in secondary packing department.
      • Take the printed label and pest on the bottle manually.    
      • After labeling of bottle pack in outer carton if recommended.
      • After carton packing pest the hologram, Barcode on specific place of carton.
      • And finally packed in corrugated box and send into the finished good storage area.
      • Maintain the record in respective log book.

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  

  • 9.0  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

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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