sop for preparation checking and approval of artwork

 

 

1.0 OBJECTIVE 
1.1 The printed packaging material like labels, cartons, leaflet, insert etc having any text matter intended to be printed directly on the container, held extremely important position in pharmaceutical industry as they provide valuable information on identity, strength, dosage schedule and expiry of the product. Various legal requirements and warnings are also to be printed on them. In absence of such information, it may become very dangerous / risky and sometimes life threatening, if such products are dispensed. The printed material that includes labels, cartons, inserts and shippers, status labels etc. are sent for printing after its art work approval for compliance to the in house guidelines. This Procedure gives the guideline to be followed for approval of the artwork, to ensure that materials carry all the required information correctly and they are controlled.

2.0 SCOPE
2.1 This SOP is applicable for all the printed materials i.e. printed cartons, labels, unit cartons and leaflets, pre-printed status labels, shippers consumed
3.0 RESPONSIBILITY
3.1 Officer –Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager –Quality Assurance – Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head –Quality Assurance
5.0 REFERENCE(S)
5.1 In-House

6.0 PROCEDURE
6.1 New Product Artwork: After confirmation of the product, follow the steps as given below.
6.1.1 Check whether we have the change parts which can accommodate the current product in to the pack. If not, give the product details like size, bottle size expected pack size to the packing machinery manufacturers and get the required layout. Before deciding the machine for packing, consider the expected volume of the product to be handled. Provide the details of the packaging style / layout to the client.
6.1.2 Take the printout of artwork and put down the artwork number and revision no. in specified place. The numbering system is given below:
AW/XX/YY/NNN-ZZ
AW : Art Work
/ : For Separation
*XX : Initial of Dosage Form (e.g. Liquid Injection= LI,)
/ : For Separation
YY : Packing Material Code (IC = Inner Carton, OC = Outer
Carton, SL = Steaker Label, PI = Packing Insert etc.)
/ : For Separation
NNN : Serial Number of Art Work
– : For Separation
ZZ : Revision number of artwork
e.g. AW/LI/IC/001-00, etc.
6.1.3 On receiving of draft copy of artwork from packing material developer QA personnel shall check the artwork and send to Production Head, QC Head for review and approval.
6.1.4 Before sending the artwork QA person shall attached the approved product permission and “Checklist for Artwork” as per Format No. Each department will sign in specified column of checklist.
6.1.5 The text matter given by the packaging department will be sent to production department for checking of the size, colour and composition of carton / foil / label and type / size of printing zone.
6.1.6 After verification by Production Head, it will be sent to QC department for review.
6.1.7 After verified by QC department the artwork will be sent to QA department for it’s final verification and approval.
6.1.8 QA department thoroughly reviewed the artwork one by one and after it’s verification QA will be approved the artwork.
6.1.9 After approval of QA department it will be sent to packaging material developer for further process.
6.1.10 In case of any correction required in artwork Head QA shall mark the correction and send back to packing material developer for correction and follow the point no. 7.1.3 to 7.1.9.
6.1.11 QA person shall prepare the artwork revision history and approved artwork index as per Format No.
6.2 Distribution and Control of Approved Art Work
6.2.1 If art work comply all the requirements, It will be approved by Head -QA and it should be stamped with “MASTER COPY” in red ink. QA Department will take Xerox copy of this approved artwork, it will be stamped with “CONTROLLED COPY” in green ink and it’s one copy will be sent to the following authorities separately:
6.2.1.1 Packaging Material Developer (for reference and printing of packing material).
6.2.1.2 Production Department (file it in the Approved Art Work’s File for reference).
6.2.1.3 Quality Control Department (file it in the Approved Art Work’s File for reference and checking of printed material).
Note: All the original approved copy of respective products will be stored in a separate file under control of Head–QA, which will be accessible only for an authorized person.



6.3 If any dummy carton available put the copy along with the master artwork.
6.4 QA person shall maintain the logbook for issuance and retrieval of artwork as per Format No.
6.5 Master copy of old artwork should be affixed the Obsolete Stamp in red ink and controlled copies received from different departments shall be destroyed by QA person.
6.6 Obsolete copy of artwork shall be retained for 5 years at QA document cell.
6.7 On receipt of the approved artwork copy Purchase Department will prepare the list of requirement for the relevant artwork, fill the request note / Purchase Order and send it’s one copy each to respective printer and QA department.
6.8 Procedure to be followed in case of any change made in the existing artwork
6.8.1 In case of any change in the approved artwork following procedure is to be followed:
6.8.1.1 For any change suggested in the artwork, initially Packaging Material Developer /Purchase Department will make change in the art work in co-ordination with the Head QA.
6.8.1.2 During the change, the amendment sheet for the change made shall be attached along with the revised artwork and sent to QA department.
6.8.1.3 QA person shall check the artwork and send to Head QC, Head Production and Head QA for review and approval.
6.8.1.4 Follow the procedure as mentioned in point no. 7.1.3 to 7.7.
6.8.2 After getting approval from all the above concerned departments, it will be sent to purchase department for the intimation and further follow up with the respective printers related with withdrawal of existing old artworks.
7.0 HISTORY
8.0 ABBREVIATIONS

SOP : Standard Operating Procedure
QA : Quality Assurance
9.0 ANNEXURE

Annexure No.	Title of Annexure
Annexure-I	Checklist for Sterile Preparation
Annexure-II	Art Work Revision History
Annexure-III	Approved Artwork Index
Annexure-IV	log book for issuance and retrieval of approved art work

 

ANNEXURE-I

CHECKLIST FOR STERILE PREPARATION

Artwork No.
Product Name :
Generic Name
NAME OF PACKING MATERIAL (✔) IN THE SPECIFIED BOX		Inner Carton           Outer Carton          Packing Insert           Label

Sr. No.	Parameters for Checking of Artwork	Checked By (Ok / Not Ok)
		Production	QC	QA
1.	Generic Name and Pharmacopoeial Name
2.	Brand Name
3.	Composition
4.	Colour & Design
5.	Each…. ml. contains (For Liquid Inj.)
6.	Manufacturing License No.
7.	Caution of Schedule “G”
8.	Warning of Schedule “H”. Schedule “H” Drug. To be sold by retail under prescription of a registered medical practitioner only.
9.	Warning of Schedule “H1”. Schedule “H1” Drug. It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner.
10.	Registered / Trade Mark Applied For (® or ™)
11.	Caution (special caution if any product ) /Warning
12.	Red line: red vertical line printed on the left side throughout body of carton not less than 1 mm without disturbing the other printing matter.
13.	Rx  To be printed at left side top of corner of the carton
14.	Storage Condition:
15.	Dosage:
16.	Address and Logo of Marketed Firm:
17.	Address and Logo of Manufactured Firm:
18.	Size (L x  W x H) for Carton , (L x W) for Label
19.	Pack Size
20.	Non- Varnish  Zone
21.	Batch No. (IN ENGLISH / HINDI)
22.	Mfg date ( IN ENGLISH / HINDI)
23.	Exp Date  (IN ENGLISH / HINDI)
24.	M.R.P ( Inclusive of all taxes) (IN  ENGLISH / HINDI)
Approved By (Head QA): Sign & Date:

 

ANNEXURE-II

 

Artwork Revision History

Product Name:

 

Packing Material: Label/Packing Insert/Inner Carton/ Outer Carton

 

Category: Physician’s Sample/Sale

Artwork No.	Reason For Change	Revision No.	Effective Date

Approved By (Head QA):

Sign/Date

ANNEXURE-III

APPROVED ART WORK INDEX

Sr. No.	Product Name	Category (Physician’s Sample/Sale)	Approved Artwork Number
			Label	Packing Insert	Inner Carton	Outer Carton

ANNEXURE-IV

LOG BOOK FOR ISSUANCE AND RETRIEVAL OF APPROVED ART WORK