SOP FOR PREPARATION, APPROVAL, ISSUE AND CONTROL OF ART WORKS FOR LABELING OF DRUG PRODUCTS
PURPOSE: To lay down the procedure for preparation, approval, issue and control of art works for labeling of drug products intended for commercial use.
SCOPE: This SOP is applicable for preparation, approval, issue and control of artworks for labeling of drug products intended for commercial.
RESPONSIBILITY
Preparation of SOPs: Officer/ Executive of Concerned Departments
Checking and Review of the SOPs: Next Level of the Concerned Department
Approval of the SOPs: Head of Concerned Department
Authorizing of SOP: Head QA/ His or her Designee
Quality control to prepare the Artwork, positives, Shade cards and Specimen.
QA (Documentation) to issue and control of Artwork, positives, Shade cards and Specimen.
Purchase and QC to procure shade cards and to retrieve user copy, positive and shade cards from printer.
ACCOUNTABILITY: The accountability of implementation and ensuring compliance of the SOP lies with head of respective Department.
PROCEDURE:
Artwork Approval:
R&D (Packaging Development) shall design/prepare the artwork for labels, product information leaflets, cartons, foils etc. along with color scheme in conformance with approved regulatory submissions and customer requirements.
If required, R&D (Packaging Development) shall submit the artwork to customer for the approval. R&D shall update the customer approval record.
Each artwork shall be allotted a unique number same as material code.
Based on the approval of artwork by customer, Quality control shall prepare Master copy and 2 user copies of the artwork, and the same shall be circulated for approval of Heads of plant, Head-PD, Head-QA or their designees.
Quality Control shall submit the approved master & user copies of artwork to QA.
QA shall issue one set of approved user copy of artwork to Quality control. The issue details shall be recorded in artwork control record.
QA shall issue the second approved set of user copy of artwork to Purchase for arranging the print proofs (for commercial batches) and record the details in artwork control record.
Quality control shall review the print proofs against the approved user copy of artwork available with them to QA for approval. QC and QA shall approve the print proofs.
If required, Quality control should send the print proofs to customer for approval. QC shall maintain the record of approval.
Once the print proof is approved, QC shall inform Purchase about the approval and should stamp “Approved” on the print proofs.
QC shall submit the approved print proofs to QA (Documentation).
QA shall issue one set of approved print proofs (or output to QC for reference and one set to Purchase for forward to printer. Issue details shall be recorded in artwork control record.
Unauthorized photocopying of artwork is prohibited.
Shade cards approval:
Purchase shall procure 4 sets of shade cards from the printer along with the print proof or with the first commercial consignment. The shade cards shall include acceptable range for all colors (Lighter intensity, standard and darker intensity). QC shall send the shade cards to Head-QC & Head- QA or their designees for approval.
Quality control shall submit the approved shade cards to QA.
QA shall issue one set of shade cards each to QC for reference purpose and purchase for forwarding to printer. The issue details shall be recorded in artwork control record.
Specimen approval:
Wherever shade cards are not applicable Quality control shall arrange 3 sets of specimens and shall send for approval of Head QC and Head QA or their designees.
Quality control shall submit approved specimen to QA.
QA shall issue one specimen each to QC for reference purpose. The issue details shall be recorded in artwork control record.
Revision of approved artwork:
Any changes necessary or desirable in approved artwork shall be done as per Change control Programmed.
Original artwork shall be prepared, approved and issued
QC shall retrieve the obsolete copies of artwork / positives / shade cards / print proofs from the printer / printers along with the revised print proofs and forward to QA documentation. The print plate destruction note / certification shall be also taken from the printer and forwarded to QA documentation.
The revised print proofs shall be approved and issued
Shade cards or specimens of revised artworks shall be prepared and approved
Artwork number is applicable only for the commercial batches.
Obsolete master artwork shall be stamped as “OBSOLETE” and shall be stored on documentation cell for future reference.
QA shall retrieve the obsolete copies of artwork / positives / shade cards / print proofs / specimen from Purchase and QC (Shade card or specimen) and shall destroy them. The destruction details shall be records in the artwork control record.
QA shall make an entry for the certification / note for destruction of the print plate at printers end in the artwork control record and the note / certificate shall be attached to the artwork control record.
QA shall certify the absence of obsolete printed packaging material at printer’s location by mentioning all documents of artwork and print plate not available at printers end and same shall be signed off and dated in the artwork control record.
REFERENCE:
SOP FOR SOP.
Document control system