SOP for Handling of Artwork

1. OBJECTIVE:

The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork.

2. SCOPE: 

This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility.

3. RESPONSIBILITY:
   1. Marketing: Responsible for Color and Design
   2. Production Department: Responsible for mentioning size as per machine.
   3. Regulatory Affairs: Responsible for Regulatory related specifications.
   4. Quality Control: Responsible for Pharmacopeial grade specifications.
   5. Head QA / Designee QA: Responsible to carry out the activity and finalize.
4. PROCEDURE:
   1. Preparation and Approval of artwork:

1. The artwork preparation to be initiated after receiving the approved product Intimation form from marketing head to QA. 
2. QA along with Marketing head need to arrange details such as text matter, dimensions, or specimen sample from principal company and same details to be forwarded to designer.
3. For new product, R&D head to provide all technical details (i.e. Description of tablets/capsule, Dimension of tablet/capsule, Details of the primary packaging material with gsm) to QA.
4. R&D head to provide product samples to production department for development of change parts layout / drawing.
5. Production and QA will approve machine change part layout /drawing.
6. QA head will maintain request for creation of item code for primary and secondary packing material.
7. Item code to be appeared on artwork of printed packaging materials for identification.   
8. QA shall use following information to develop the draft art work. Text matter (from marketing), Brand (from marketing), Pack style (from marketing), Pantone shade no. (From marketing), Font style (from marketing), Barcode, Pharmacode, Dimensions (from approved machine change part).
9. On receiving of artwork from designer, QA head shall verify the artwork against specimen or specification. 
10. Comments shall be shared with designer for correction.
11. QA, after incorporating final suggestions, forward soft (pdf) copy to purchase and maintain the hard copy as well as soft copy of the same.
12. Purchase department shall forward this CDR with JPEG file and approved artwork copy to vendor for preparation of positive and printing proofs with shade card.
13. After receiving printing approval QA will verify the correctness of text and shades. QA will approve shades. 
14. In case any discrepancy is found in print proof, the same shall be intimated to purchase department and purchase department shall ask vendor to provide new print proof.
15. Any further changes/ modification in art work to be routed through change control procedure.
16. Once the corrected proof is received from the vendor, vendor shall prepare the positive & four sets of print proof and forward copies to QA and/or purchase.
17. QA will approve and seek approval from customer in case of site transfer product through marketing. In this event, send electronically for customer approval.
18. After receiving customer approval electronically, print proof approval, QA will approve the artwork and will maintain the record accordingly. 
19. Purchase will forward approved print proof to vendor for generating shade cards. Vendor will forward then shade cards [covering (LSD) light, standard and dark shade] to QA and /or purchase. 
20. After receiving the customer approved shade card, QA will give the printing approval. 
21. QC (Packing material) shall maintain the record of approved shade cards (F/QA026/04).
22. Need base customer approval can be accepted through e-mail after their approval on shade card, while approved shade cards are in transit from the customer to the site.
23. Revision/retrieval and destruction procedure:-
    1. Revision in artwork will be carried out through change control procedure. New item code will be assigned.  Revision can be effected on account of change in packaging specification, pack style, shade/color scheme, text, regulatory compliance, and Pharmacopoeial status and buyer requirement (but not limited to).
    2. After approval of Change control from QA, packaging shall prepare the revised artwork with new version of artwork number.
    3. Before implementation of revised artwork, previous version of printing plates/ printing cylinders, CD, shade card and approved hard copy of artwork & printing proof will be taken back from vendor by QA department through purchase department. Record of the same shall be maintained.
    4. QA will ensure the destruction of previous version of printing plates/ printing cylinders, CD, shade card and approved hard copy of printing proof and record the details
    5. After destruction, QA Packaging shall transfer the destruction documents to location QA.
    6. Revised art work will be issued to vendor through purchase.
    7. Implementation of new art work and fate of existing old printed packaging material will be decided on request and confirmation from any one of marketing/ planning / regulatory/principal.  
    8. Destruction of old printed packaging materials to be done as per respective SOP.
    9. “Obsolete” artwork shall be preserved up to 1 year after expiry of last batch manufactured with old artwork. 
    10. Artwork for regulatory market shall be approved by PL holder / QP / customer.

NOTE : In case of printed shipper, BOPP (if applicable) and strapping roll (if applicable),  designed/ standard art work given by marketing / principal company/ PL holder  will be followed for printing.

4. In the case of packaging material supplied by contract giver then the QC shall verified the same based on the shade card provided by contract giver. 
5. TRAINING:

Trainer:   Head – Quality Assurance

Trainees:  All Departmental / Sectional Heads

6. DISTRIBUTION:

Controlled Copy No. 1 :  Head of Department – Quality Assurance

Controlled Copy No. 2 :  Head of Department – Quality Control  

Controlled Copy No. 3 :  Head of Department – Marketing 

Controlled Copy No. 4 :  Head of Department – Purchase

Original Copy :  Quality Assurance

7. ANNEXURE(S):

Annexure-I : Product Intimation Form

Annexure-II : Distribution record of Artwork / Print proof / Shade cards.

Annexure-III : Record of receipt and destruction of artwork.

Annexure-IV : Issuance and withdrawal of approved shade cards of printed 

                                   packaging material.

8. REFERENCE(S):

  Nil

9. REVISION HISTORY:

Sr. No.	Revision No.	Change Control No.	Details of Revision	Reason(s) for Revision
1	00	—————	New SOP	New SOP