Scribd
Upload
236 views2 pages

Artwork checking SOP

Artwork development

Uploaded by

pandeygajendra2907
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
236 views2 pages

Artwork checking SOP

Artwork development

Uploaded by

pandeygajendra2907
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 2

1.

0 PURPOSE:
The purpose of this SOP is to laydown a procedure for checking and control the artwork of leaflet,
label, carton, tube or any other printed material.
2.0 SCOPE:
This procedure is applicable for checking the artwork of leaflet, label, carton tube or any other
printed material.
3.0 RESPONSIBILITY :
Executive QA/QC are responsible for checking of Artwork.
Manager QA are responsible for approving of Artwork.
Maintenance Supervisor/ Manager is responsible to verify the dimensions with respect to machine
suitability.
Purchase department is responsible to send finally approved Artwork to Supplier.
4.0 PROCEDURE:
4.1 To develop the design of the artwork purchase department shall send the artwork design to the
designer.
4.2 Designer shall send the new developed artwork to purchase department and regulatory
department / purchase department shall send the artwork to QC for checking the artwork.
4.3 Before checking of artwork, check if license is available, otherwise write instruction on artwork as
license is not available and stop the checking. Inform the same to purchase department /customer.

4.4 Check artwork for following –


i) Brand Name, Generic Name
ii) Composition
iii) Trademark/ Registered
iv) Mfg. Lic. No./Code No.
v) B. No.
vi) Mfg. Dt.
vii) Exp. Dt.
viii) M.R.P. (Inclusive of all Taxes)
ix)
“Physician’s Sample Not to be Sold”
x) Manufacturer name or marketed by and address.
xi) Fill volume / weight.
xii) Dimension and size
xiii) Storage
xiv) Dosage
xv) Overprinting space, unvarnished Zone
xvi) For more instruction follow drugs & cosmetic act, 1940 & rules 1945.
xvii) Version No. of artwork / item code of artwork
4.5 For the version no. Put “A” A – for Artwork before item code (Generated from ERP) of particular
packing material. After item code put “ /NN” NN – numerical value for the version number e.g.
the artwork number of tube for Cortiphenel Eye Ointment will be “PBPMAL001/00”
4.6 The version number shall be changed if any changes required to be done.
4.7 The version number should be printed on suitable place of the artwork.
4.8 The version number should be different in font from the other text font of the artwork.
4.9 Maintenance Supervisor will verify the dimensions of tubes, labels, cartons and leaflets with
respect to machine suitability.
4.10 The artwork which is correct in all respect will be stamped as “Approved” only for text matter.
4.11 The correction if any, mark on the artwork and send artwork to rectify it.
4.12 Once artwork is approved for text matter, send previously approved sample of tube, carton, label,
leaflet etc to supplier for colour shade verification.
4.13 After getting bromide for tube and shade card for cartons, leaflet from supplier, check it again for
text matter and colour shade.
4.14 The artwork which is approved in text matter and colour shade will be stamped as “Approved”.
4.15 Ask for three samples of Approved specimen from supplier, one sample for factory record, Second
copy for H.O and third copy for supplier.
4.16 In case of new product, Send final approved artwork to party for their approval.
4.17 After final approval from party and factory, purchase department will raise PO for specified
packing material along with Approved Shade card / specimen / bromide.
4.18 Without approved shade card / specimen / bromide, do not allow supplier to start production.
4.19 If there is any change in artwork then the change shall be directed through change control.
4.20 If the change is approved then the artwork and packing material of last version shall be destroyed.
4.21 The specification of the artwork shall be revised by mentioning the change in change history.
4.22 The item code of old packing material shall be blocked in ERP system.
5.0 REFERENCE:
Inhouse.
6.0 ANNEXURE:
Nil.
7.0 FORMAT:
Nil.
8.0 DOCUMENT HISTORY:
8.1 Revision History:

Change control
Version No. Page No. Reason for revision Effective Date
Number (if applicable)
00 NA - NA 01/01/10
Review was done on
01 NA NA 01/01/12
date 01/01/12
Review was done on
02 NA NA 01/01/14
date 01/01/14
Review was done on
03 NA NA 01/01/16
date 01/01/16
04 NA Periodic Revision 08/2017 01/03/18
To include:
i) Address Change
05 NA 07/2018 01/12/18
ii) Format Numbering
System Change
i) Periodic Revision
ii) Address in Header 29/2020
06 NA section changed to be
in line with the address
in WHO Certificate.

You might also like