SOP Title: Control of Artworks
- Objective:
To lay down procedure for control of artwork preparation, approval, archival and issuance of artworks
- Scope:
This procedure is applicable for the artworks of all products manufactured at the site.
- Responsibility:
Quality Assurance Department: To prepare, review, approve and issue of artworks
Production Department: To review the artworks for correctness
Quality Control Department: To review and test the artwork
- Accountability:
Head QA Department
- Procedure:
- Definitions:
Artwork: Illustrative standard work prepared and approved for reproduction of finished products packaging components i.e. printed foil, cartons, package inserts, labels etc that is consist of drawing, painting, graphics or anything that is not typeset as only text and usually requires regulatory control as per the scope of this SOP.
- Procedure:
| 5.2.1 | All finished products packaging components as applicable shall be provided with approved artworks which shall be maintained in QA Departments. | |
| 5.2.2 | On receipt of the packaging details from the Marketing Department or contract giver, the cutter guide design for the carton shall be first made taking into account to check the suitability of packing, the text printing and pharmacode | |
| 5.2.3 | The cutter guide drawing with dimensions is signed off by Head of Production and Quality Assurance and is then sent to the Marketing Department or customer for their approval. | |
| 5.2.4 | On receipt of the signed off cutter guide by the Marketing Department / customer, the text matter and colour shall be incorporated onto the carton/packaging component. | |
| 5.2.5 | The printer shall be asked to provide the wet proof of the carton design and shade cards light to dark colour (4 copies) which shall be circulated to the responsible persons (QC and Production Head) for review and comments (Wet proof are not required if the art works already exist and sourced from approved suppliers). | |
| 5.2.6 | Once the artwork and the shade cards have been signed off by the respective persons listed in the artwork circulating form head QA shall sign off the final document for their approval. | |
| 5.2.7 | In case the wet proof or shade cards comes with corrections then the corrected version shall be resubmitted by the printer and which shall again be circulated to the responsible person giving the circulating document as revision 1, then revision 2 and so on till final correction of artwork | |
| 5.2.8 | On receipt of the approved copies of the artwork and shade cards from the Marketing Department/customer (Contract giver), Head QA shall issue a copy to Purchase Department or intimate for initiating the printing. | |
| 5.2.9 | Once the wet proof and shade cards approved by Marketing Department or customer (contract giver) then it shall be submitted to the customer to the relevant Regulatory Authority for their approval if required. | |
| If the artwork of cartons are to be provided by the customer (wherever applicable & for exports) following procedure shall be followed: | ||
| 5.2.10 | Once the cutter guide has been approved the customer shall develop the artwork based on this cutter guide. The customer shall be asked to send the same on a CD or 4 hard copies of the signed off document. | |
| 5.2.11 | The customer approved artwork on the CD shall be archived in QA Department and then be issued to Purchase Department for initiating the wet proof and shade cards. At this stage, item codes, pharmacodes and the product licence number shall be indicated on the hard copy and issued to the printer. | |
| 5.2.12 | The wet proof and the shade cards (4 copies) light to dark colours, obtained from the printer shall be circulated to the responsible persons for review and comments. | |
| 5.2.13 | Once the artwork and the shade cards have been signed off by the respective persons, Head QA shall sign off the final document for sending to the customer for their approval. | |
| 5.2.14 | In case the wet proof and or shade cards requires corrections then the same shall be obtained from the printer with the corrected version and this version shall again be circulated to the responsible persons for review and comments giving the circulating document as revision 1, then revision 2 and so on till final correction of artwork. | |
| 5.2.15 | Once the wet proof and shade cards approved by the customer (contract giver) then it shall be submitted by the customer to the relevant regulatory authority for their approval if warranted. | |
| 5.2.16 | On receipt of the approved copies of the artwork and shade cards from the customer (Contract giver)/Regulatory authorities, a copy of the same shall be issued to Purchase Department for initiating the printing. | |
| Artwork for package inserts and printed foil | ||
| 5.2.17 | The text for package insert and the printed foil shall be prepared and approved by QA Department after receiving the blister/strip layout details. | |
| 5.2.18 | Once the text for the package insert and blister foil is received, it shall be send to the printer for development of wet proof and shade cards or a pdf file and the same is circulated to all responsible persons for review and comments. | |
| 5.2.19 | If the wet proof and shade card requires any correction it shall be corrected by same procedure as mentioned in 5.2.14 | |
| 5.2.20 | The approved laser proof or wet proof and shade cards (if relevant) for foil and package insert is sent to the Marketing Department/customer for their comments and approval. | |
| 5.2.21 | Once the wet proof and shade cards approved by the Marketing Department/customer (contract giver) then it shall be submitted by the customer to the relevant regulatory authority for their approval if warranted. | |
| 5.2.22 | On receipt of the approved copies of the artwork and shade cards from the Marketing Department /customer (Contract giver)/Regulatory Authorities, head QA would issue a copy to Purchase Department for initiating the printing. | |
| Labels | ||
| 5.2.23 | Same procedure shall be followed as mentioned in 5.2.17 to 5.2.22 for artwork approval of the labels. | |
| 5.2.24 | The details on the carton/foil/label/tubes/inserts must be verified against the signed approved hard copy or pdf file from the customer. | |
| 5.2.25 | Artwork Numbering System | |
| 5.2.26 | Item code shall be considered as artwork number. | |
| Issuance of artworks | ||
| 5.2.27 | All the approved artworks shall be kept in Quality Assurance Department.
The controlled copy of the artwork/wet proof and shade cards to Regulatory, Marketing, Purchase Department, Production and Quality Control Department shall be issued whenever required. |
|
| 5.2.28 | Change in the artwork | |
| 5.2.29 | In case of any change required in the current artworks, the artwork shall be reviewed only after raising a change control. | |
| 5.2.30 | If required, the change control shall be approved by Marketing Department/ customer and Head QA Department | |
| 5.2.31 | On approval of change control from, the Marketing Department/customer and head QA, the preparation of the new artwork shall be arranged together with Purchase Department following the procedure described as above. | |
| 5.2.32 | New artwork number shall be assigned in the case of any change in the current artwork. | |
| 5.2.33 | Revised artwork shall be submitted for regulatory approval if required, by the Marketing Department/customer. | |
| 5.2.34 | Upon approval of revised artwork superseded copies of artwork shall be retrieved from Production, Regulatory, Quality Control and Purchase Department. In addition QC shall also return the specification relating to this particular. QA will only issue new approved copies on receipt of the superseded artwork. | |
| Before approval of the new proof of the amended artwork, the following consideration shall be taken | ||
| 5.2.35 | The physical stock of existing printed packaging material shall be taken, also the quantity ordered by Purchase Department shall be considered. | |
| 5.2.36 | The Marketing Department/customer shall be informed about the available stock of printed packaging material. | |
| 5.2.37 | If the Marketing Department/customer prefers not to use the stock available, the existing stock shall be destroyed. The destruction shall be carried out in presence of QA person. | |
| 5.2.38 | If the Marketing Department/customer prefers to consume the available stocks of printed packaging materials, then the wet proof shall be approved once the stocks gets consumed. | |
| 5.2.39 | Once the change is implemented then QC Specification shall be revised the copy of revised specification shall be forwarded to Purchase Department. The previous specification shall be superseded and withdrawn. | |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QAP | Quality Assurance Procedure |
| QA | Quality Assurance |
| CD | Compact Disk |
| QC | Quality Control |
*Note – Ready to use SOP available in “DOWNLOAD” Section.