Batch Packaging Record

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Batch Packaging Record:

Prepared by : Kunal Vanparia Guided by : Dr. Nirav Patel ANAND PHARMACY COLLEGE Batch Packaging Record

Questions to be asked…:

Write a note on batch packaging rec O rds . Questions to be asked …

Batch Packaging Record:

A Batch Packaging Record should be kept for each batch or part batch processed. This document is based on packaging operation. It should be based on the relevant parts of the Packaging Instructions and the method of preparation of such records should be designed to avoid transcription errors. Batch Packaging Record

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Before any processing begins, check shall be performed and recorded to ensure that the equipment and work station are clear of previous products, documents or materials not required for the planned process are removed and that equip0ment is clean an suitable for use.

The following information should be entered at the time each action is taken and, after completion, the record should be dated and signed in agreement bythe person(s) responsible for the packaging operations::

the name of the product; the date(s) and times of the packaging operations; the name of the responsible person carrying out the packaging operation; the initials of the operators of the different significant steps; records of checks for identity and conformity with the Packaging Instructions including the results of in-process controls; The following information should be entered at the time each action is taken and, after completion, the record should be dated and signed in agreement bythe person(s) responsible for the packaging operations :

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details of the packaging operations carried out, including references to equipment and the packaging lines used; whenever possible, samples of printed packaging materials used, including specimens of the batch coding, expiry dating and any additional overprinting; notes on any special problems or unusual events including details with signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions;

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the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation

Procedure for Issue of Batch Packing Record:

OBJECTIVE To lay down a Procedure for Issue of Batch packing record to production. SCOPE This SOP is applicable to Formulations unit. RESPONSIBILITY Executive - Planning. ACCOUNTABILITY Manager -Production Planning and Inventory Control. Procedure for Issue of Batch Packing Record

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PROCEDURE Batch Packing record is to be issued 72 hours in advance to production w.r.t day wise packing schedule for the month Enter the details in the Batch number control register before issue of the Batch packing Record Take one Print out of the Batch packing record with Batch number details. The Batch packing record to be duly issued by Planning Executive. Handover the authorized Batch packing record to Officer / Executive - Production and take his signature in the Batch number control register.

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In case of cancellation of Batch packing record after issue to production, it is to be returned to the Planning department and to be recorded in the Batch number control register. In exigencies, if a work order is to be re-issued, it is to be recommended by Quality Assurance department and authorized by Manager - Production Planning and Inventory Control.

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Format of BPR HARDIK Pharmaceuticals, chandan kunj , khambhat Name of product:- batch no.:- Strength & qty:- batch size:- Category:- date of mfing :- MFRno .:- date of expiry:-

REQUISITION SLIP:

REQUISITION SLIP Sr no. Name of packing material std ATR no. Label claim Qty. issued Qty. used Remark

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Sr no. Marking on empty container Wt. of empty container Wt. of filled container Wt. of content IPQC Visual examination of empty containers Date Total no. of container received Total no. of container examined No. of container rejected

FILLING:

FILLING Date Time of filling started Time of filling stopped No. of container filled

PACKAGING:

PACKAGING Date Starting time Closed time Pack Discription of packaging Packing size Attach the specimen of packaging materials Total no. of packet Date of completion Qty of samples taken by Q.C. person

BATCH PACKAGING RECORD FOR VARIOUS DOSAGE FORMS….:

Capsules…. BATCH PACKAGING RECORD FOR VARIOUS DOSAGE FORMS ….

BATCH PACKAGING RECORD:

BATCH PACKAGING RECORD Packaging description______________________________ Precoding of labels and printed packaging materials examined & (attach specimen) verified by_______________________________ No. of Precoded Labels received___________________________________ Printed packaging material received___________________ Total Quantity packed______________________________________ Date of completion________________________________________ Qty. collected as samples by Q/C Department___________________

Reconciliation of labelling & Packaging Materials:

Reconciliation of labelling & Packaging Materials Actual yield ____________________________________________________ Theoretical yield ________________________________________________ Whether within limits _____________________________________________ Q/C Report of finished product _____________________________________ Status No. & date and release order) ________________________________ Sign. of Supervisor (approved technical staff) Date of release _________________________________________________ Qty. released ___________________________________________________ Date of transfer of finished ________________________________________ Product to warehouse _____________________________________________ Counter signed _________________________ HEAD OF QUALITY CONTROL DEPARTMENT

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Tablet…

BATCH PACKAGING RECORD :- :

Product name:_______________ Batch No: ________________ Packaging Description:__________ Precoding of labels and printed packaging materials examined and verified by:- (attach specimen) Quantity of packing material received( PM store):___________________ Quantity of packing material approved(By PM department):-_____________ Total quantity packed:________________ Date of completion:__________________ Qty collected as samples by Q.C department:____________ BATCH PACKAGING RECORD :-

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Date Start Time Close Time Name of person responsible for Packaging Other Operation Packaging Checking Packed Containers Counting & Filling in Boxes

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Oral Liquid…

BATCH PACKAGING RECORDS:

M/S (Name & address of company) Product name Generic name Batch no. Batch size Mfg. Date Exp. Date Container description Precoding of labels / Printing packaging Material examined and verified by Precoded 1. Labels received 2. Carton received BATCH PACKAGING RECORDS

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Labelled claim Precautions taken (Specify) Result of bulk finished Product analysis (Status, report no. & date) No. of refiltered and refilled bottles Dt Time Personnel responsible for Filling Commenced Filling stopped Chk. of empty bottles Chk. of filled bottles Chk. of labeled bottles Chk. of cartons

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Packaging in charge Sign. Labels cartons Requisitioned / received Used Returned Destroyed Destroyed on (date) Destroyed by

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Opthalmic …

Batch Packaging & Labeling Records:

Batch Packaging & Labeling Records Product name_______________________ Batch no _______________________ Strength___________________________ batch size ______________________ Category___________________________ mfg date _______________________ MFG no____________________________ exp date _______________________ Batch Packaging & Labeling Records Description of packaging______________________________________________ Pre-coding of labels & printed packaging materials, examined & verified by _______________________________________________ No. of pre-coded ____________________________________________________ (ii). Printed packaging material received __________________________________ Result of bulk finished products ________________________________________ Sign. Of officer _____________________________________________________ Reconciliation of labeling and packaging material Quantity of material received___________________________________________ Quantity of material destroyed__________________________________________ Quantity of material used _____________________________________________ Quantity of material returned___________________________________________ Date of release ____________________ quantity release ____________________ Signature of supervisor _______________

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Parenteral …

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Batch Packaging & Labeling Records Product name_______________________ Batch no _______________________ Strength___________________________ batch size ______________________ Category___________________________ mfg date _______________________ MFG no____________________________ exp date _______________________ Batch Packaging & Labeling Records Description of packaging______________________________________________ Pre-coding of labels & printed packaging materials, examined & verified by _______________________________________________ No. of pre-coded ____________________________________________________ (ii). Printed packaging material received __________________________________ Result of bulk finished products ________________________________________ Sign. Of officer _____________________________________________________ Reconciliation of labeling and packaging material Quantity of material received___________________________________________ Quantity of material destroyed__________________________________________ Quantity of material used _____________________________________________ Quantity of material returned___________________________________________ Date of release ____________________ quantity release ____________________ Signature of supervisor _______________

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Some Filling & Packaging Machines…

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Rotary tube (paste) filling and closing (Crimping) Machine with Coding Device

Cosmetic powder packing machine :

Cosmetic powder packing machine

Liquid Packaging Machine:

Liquid Packaging Machine

Vertical self adhesive labeling machine(60-240 Bottles/min:

Vertical self adhesive labeling machine(60-240 Bottles/min

Filling & Packing of semi-solid preparation::

Filling & Packing of semi-solid preparation:

References…:

http://www.gmpua.com/World/GMPManual/grafiken/15.C-5aed.jpg http://www.cpier.pku.edu.cn/doc/06EU/Pack%20%28eng%29.pdf http://gmponblog.vinvarun.biz/2008/11/procedure-for-issue-of-batch-packing.html References …

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ThAnKs … ThAnKs … ThAnKs … ThE EnD … ThAnKs …

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