MPC Exam Paper

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Master Packaging Card

Packaging Development Department Restricted circulation


MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 1 of 6
Reference MFC No: NRX/TB/05/EU/
1. Packaging Information:
Blister pack : 3 x 10’s count.
2. Storage Condition:
Not Specified.
3. Precautions:
Follow the current approved standard operating procedures during packing.

4. Packaging Formula: Batch Quantity: 100000 Tablets


Item Code Name of the Material Quantity*
LIDDING FOIL: 271 mm wide, 25 micron Printed Al. Foil with 6 – 8 GSM
P0116554 4.63 Kg
HSL Coating. Blister Size: 85 x 55 mm
FORMING FILM: Clear 250 Micron PVC Film/25 Micron PE/90 GSM
P0300968 27.04 Kg
PVdC (Width 275 mm)
PRINTED CARTON: Printed Carton. For 3x10’s
P1034819 For cartoning / Manual packing. Dimension: 91 x 59 x 38 mm. 3434 No’s
Pharma code: 34819
LEAFLET: Printed Leaflet.
P1519464 3434 No’s
Dimension: 167 x 520mm, Pharma code: 19464
P3500422 BANDING FILM: Plastic Banding Film (WIDTH : 28 mm) (38 mm x 6) 330 Meters
PRINTED SHIPPER: 5 ply Printed Shipper.
P2000830 Dimension: 383 x 250 x 325 mm, 29 No’s
Arrangement : (91 x 4) L, {(38 x 6) x 1}W, (59 x 5)H
P1412669 PLAIN LABEL: Self-adhesive Label 29 No’s
P3100023 BOPP TAPE: BOPP TAPE: Brown printed BOPP tape.
45 Meters
P3100015
Current and effective version shall be followed.

* The above lidding foil & forming film quantities are inclusive of 13 % wastage and other packaging
material with 3 % wastage.

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
Master Packaging Card
Packaging Development Department Restricted circulation
MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 2 of 6
Reference MFC No: NRX/TB/05/EU/

5. Brief Packing Instructions:

5.1 This MPC is applicable for unit XV.


5.2 Blister pack 10 Tablets in Hard tampered Aluminum foil and clear PVC/PE/PVdC Film.
Blister Packing machine & Layout No. (EP3015 PDA – A 1903 8022). PVdC film should be
outside of the blister. Take the total number of blisters sealed in sealing station and conduct
leak test. If all the blisters pass the leak test, start the Blister packing. Batch details to be
embossing on each blister without perforation as per change part.
5.3 Coding details for Foil:
Charge: Stands for Batch Number (Alpha numerical characters)
Exp.: Stands for expiry date in the format of MM/YYYY.
Note: Only variable data to be embossed on the blister (Prefix details are given only for
reference, actuals are available on foil)
5.4 Coding details for carton:
Coding details in Human readable format
PC: 08716049024021 (14 Digit product code) (GTIN)
SN: Stands for Serial number.
Charge: For Batch Number. (Alpha numeric character).
Exp: Stands for Expiry Date (MM/YYYY).
Note: Prefix & variable data both has to be imprinted.

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
Master Packaging Card
Packaging Development Department Restricted circulation
MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 3 of 6
Reference MFC No: NRX/TB/05/EU/

2D Data Matrix
2D Data Matrix to be imprinted on each carton comprising application identifiers and PC,serial
number, Batch number and Expiry date as per GS1 standard.
The decoding of the data matrix should be in the below mentioned format
01(14digits PC) 21(Serial number) 10(Batch no.) 17(Expiry in YYMMDD format)
Note: The day of the expiry date in the data matrix code should be last day of the month.

5.5 Pack 3 blisters & one leaflet in a carton containing batch details.
5.6 “Leaflet to be folded through online folding machine and will be packed in auto cartonator.
If not feasible leaflet to be folded through offline folding machine and will be packed manually.
5.7 6 Cartons as a Banding unit.
5.8 Paste Tamper Evident Sticker (P1422450) on both sides of closing flaps on carton.
5.9 Pack 4 Bundle packs lengthwise, 1 Bundle pack widthwise to form a single row and follow
the same configuration for next 4 rows. Total 20 Bundles to be packed in the shipper.

5.10 Close the Shipper by BOPP tape.


5.11 Paste one customer approved thermal printed shipper label (P1412669) on the front and
adjacent side panel of the each shipper. The specimen sample is given below.

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
Master Packaging Card
Packaging Development Department Restricted circulation
MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 4 of 6
Reference MFC No: NRX/TB/05/EU/

CHANGE HISTORY

Revision Number Change Control Number Changes Made


00 ----- ----

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
Master Packaging Card
Packaging Development Department Restricted circulation
MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 5 of 6
Reference MFC No: NRX/TB/05/EU/

ANNEXURE - 1

1. Blister Pack 10’s count without


Perforation.

2. Blister pack 3x10’s + 1 open


Leaflet Leaflet

3. Cartons pack (Both side open


Height
type) (3x10’s blister +1 open
leaflet pack in a carton)

Length
Width

4. Banding Film (6 Cartons)

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
Master Packaging Card
Packaging Development Department Restricted circulation
MPC No: MPC/FTNA4BBE-0-00
Naproxen Aurobindo 500 mg, Effective Date:
Market: APL-Netherlands
tabletten
Supersedes: NEW
(Naproxen Tablets BP 500mg) Page 6 of 6
Reference MFC No: NRX/TB/05/EU/

Height
5. Shipper Packing with Bundle
arrangement 4(L) x 1(W) x 5(H)

Width

Length

Name Date
Prepared by
Reviewed by
Reviewed by
Approved by
Effective Date:

CS-PD-SOP-FORM-012
PACKAGING DEVELOPMENT, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090

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