Artwork Management , Purpose:
Artwork Management , To lay down the general guideline about preparation, approval and preservation of artwork, printed specimen and approved color and design standard of printed packaging materials that are required to develop packaging materials for products.
Artwork Management , Scope:
This SOP is applicable for art work development of new as well as existing products of both General and Sterile Block in XX pharmaceuticals limited.
Definition/Abbreviation:
[][]PD : Product Development
[][]PMD : Product Management Department
[][]QC : Quality Control
[][]QA : Quality Assurance
[][]SCM : Supply Chain Management
[][]XX : Current Version
Responsibilities:
[][]The roles and responsibility are as follows:
Marketing Department
[][]Preparation and checking of text for the packing materials.
[][]Raise a change control in case of any change in the existing art work.
[][]Prepare the final art work for regulatory submission.
[][]Design of all art work as per dimension and text.
Product Development Department
[][]Checking the draft art work for dimension and texts.
[][]Checking dummy carton and machine proof sample and shade card.
Quality Control
[][]Generation of packing specification according to approved artwork and shade card.
Quality Assurance
[][]Checking the text of draft, dummy and machine proof sample.
[][]Preparation and timely review of the SOP.
Head of Marketing
[][]Check and review of all Art works.
Head of Plant Operation
[][]Review of all art work.
Head of Quality Assurance
[][]Approval of all art works as per XX specification.
[][]Approval of the SOP.
Procedure:
[][]After receiving product proposal report from PMD, PD will generate Artwork Technical specification according to Annexure–I and send to PMD. PD will also preserve a copy in the product master file.
[][]PMD will generate the artwork as per Artwork Technical specification (Annexure-I) and send two copies artwork to Quality Assurance. PMD will also generate material code in ERP.
[][]Each artwork will contain the respective material code and version no. with signature of PMD personnel.
[][]Quality Assurance will check the artwork and will take comment from PD regarding label claim, pack size, primary packaging information, and width of foil etc. for any new product and new width of foil or new dimension of carton for existing products. For any correction Quality Assurance will forward the artwork copy to PMD department for further action.
[][]After all reviewing, Quality Assurance & PD will sign the artwork and then forward to Head of Plant Operation for checking.
In the meantime, size and shape (dimension) of the Packaging materials will be confirmed by machine trial or by operation with dummy samples. After receiving dummy samples from PMD, PD and Production will work jointly to finalize the size and shape.
[][]PD will provide samples of required size strips/blisters to PMD for preparation of dummy carton when requested.
[][]Head of Plant Operation will review the artwork and send to Head of Quality Assurance for final approval.
[][]Quality Assurance will send one copy of approved artwork to PMD and preserve another copy at QA.
[][]For new product, PMD will raise commercial requisition after getting three month stability declaration from PD. After commercial requisition Supply Chain will find out the source for preparation of shade card.
Selection of Color:
[][]PMD will suggest the color of Printed components by considering the following:
[][]Preferably color shall be dissimilar in different strengths of same product.
[][]Color shall be stable and not fade on storage or during any operation of the material.
[][]Suggested color shall be forwarded to PD and Quality Assurance for comment.
[][]In case of any major anomaly in color selection, final decision shall be taken jointly by PMD and PD.
Approved Color and Design Standard of Printed Packaging material:
[][]PMD will then send 5 standards of packaging materials to Quality Assurance. Quality Assurance will check the text of printed components against approved artwork and give comments. These standards are for:
=>PMD Copy
=>Quality Control Copy
=>Quality Assurance Copy
=>Supply Chain Copy
=>Supplier Copy
[][]Quality Assurance will send one copy of approved shade card along with artwork to QC for preparation of specification.
[][]After approval of specification, QA will send controlled copy of specification along with shade card to QC, PMD, Supply Chain and the Supplier.
[][]For supplier approval / alternate source development, Supply Chain will send source approval document to QC through PMD. Source approval documents are:
=>Duly filled Vendor Questionnaire
=>Vendor Approval Form
=>Certificate of Analysis/ Conformation
=>Supplied list of material
Change Control:
[][]Any change in the printed components like foil/ carton/ leaflet/ label shall be processed following SOP.
[][]Any change in pack size or brand name of the product shall require approval of local Drugs Authority/Regulatory Authority.
[][]When any change in packaging components, PMD and Supply Chain should ensure that following documents will be collected from the supplier through Obsolete Form of Artwork/ Supplier (Annexure-II). Documents are:
=>Previous version of Artwork
=>Previous version of Shade card
=>Previous version of Plate positive
=>When any supplier will be rejected from approved vendor list, Supply Chain will be proceed through Obsolete Form of Artwork/ Supplier (Annexure-II).
Annexure:
Annexure – I: Artwork Technical Specification
Annexure – II: Obsolete Form of Artwork/ Supplier