Preparation, Approval, Issue and Control of Artworks for labeling of drug products

OBJECTIVE :

To lay down the Procedure for Preparation, Approval, Issue and Control of artworks for labeling of drug products intended for commercial use.

RESPONSIBILITY :

R&D(Packaging Development) to prepare the Artwork, positives or soft copy, and procure shade cards & specimens from the printers.

QA (Documentation) to issue and control of Artwork, positives or soft copies, Shade cards and Specimen.

SCM to retrieve user copy, positives / soft copies, print proofs, shade cards and blocks from printer.

Head R&D and Head-QA to ensure compliance.

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.

R&D (packaging development) shall submit the artwork to a customer for the approval. R&D(Packaging development) shall record of the approval from customer in Customer approval record. ( refer annexure 1)

Each artwork shall be alloted a unique number same as material code.

Based on the Approval of artwork by customer, R&D (Packaging development) shall prepare Master copy and User copy of the artwork, and the same shall be circulated for approval of Head-R&D, Head-RA, Head-PD & Head-QA or their designees. (Refer annexure-2 for specimen)

Wherever positives are required (e.g.PIL, cartons etc.) R&D (Packaging Development) shall make available three sets of positives. R&D (Packaging development) & RA shall approve the positives.

The numbering of softcopies consists of seven characters, first three characters are letters denoting the product abbreviation, next character is “-” Dash, and next three characters are serial number starting from 001. The serial number should start from ‘001’ for each generic.

e.g : The  soft copy containing the artwork of Foomotidine Tablets USP 10 mg  10’s count blister will be FOM-001.

The soft copy containing the artwork of Foomotidine Tablets USP 20 mg 100’s count  will be FOM-002.

The soft copy containing the artwork of Omeprazole Capsules 10 mg 10’s blister will be OMP-001.

The soft copy containing the artwork of Omeprazole Capsules 20 mg  10’s blister will be OMP-002.

R&D (packaging development) shall submit the approved master & user copies along with the approved positives / soft copies to QA (Documentation).

QA (Documentation) shall issue a photocopy of Master artwork and one set of positive to R&D (Packaging development). The issue details shall be recorded in Artwork control record (refer annexure-4).

QA (Documentation) shall issue the photocopy of user copy of artwork along with one softcopy / positive to SCM for arranging the print proofs and record the issue details in Artwork control record.

R&D(packaging development) shall review the print proofs against master artwork /positive and forward to RA for approval. R&D (Packaging development) & RA shall approve the print proofs.

If required, R&D( Packaging development) should send the print proofs to a customer for approval. R&D( Packaging development) shall maintain the record of approval.

Once the print proof is approved,  R&D (Packaging Development) shall inform SCM for the approval and should stamp approved on the print proofs.

R&D (packaging development) shall submit the approved print proofs to QA (Documentation).

QA (Documentation) shall issue one set of approved print proofs to R&D (Packaging

Development) for reference and one set to SCM for forwarding to printer. Issue detail shall be recorded in artwork control record.

Note: SCM shall take the acknowledgment from the printer for receipt of print proofs.

Shade cards approval :

R&D (packaging development) shall procure  4 sets of approved 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 ). R&D (packaging development) shall send the shade cards to

Head-R&D,Head-QC & Head-QA or their designees for approval. Refer annexure-5 for specimen format of shade card.

R&D (packaging development) shall submit the approved shade cards to QA (Documentation).

QA (Documentation) shall issue one set of shade cards each to R&D (Packaging Development), QC for reference purpose and SCM for forwarding to printer. The issue details shall be recorded in Artwork control record.

Specimen approval :

R&D (Packaging development) shall inspect the first lot of the printed packaging material against master artwork for correctness. If correct, R&D (Packaging development) shall prepare 3 sets of specimen and shall  send for approval of  Head – R&D, Head – QC and Head – QA or their designees. Refer Annexure-6 for format of approval.

R&D (packaging development) shall submit approved specimen to QA (documentation).

QA (documentation) shall issue one specimen each to QC and R&D (packaging development) 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 SOP ” change control program “.

A separate material code shall be alloted to the revised artwork which shall become the artwork number.

Original artwork shall be prepared, approved and issued as per above steps.

SCM shall retrieve the obsolete copies of artwork/softcopies/positives/shade cards/print proofs/blocks from the printer along with the revised print proofs.

The print proofs shall be approved and issued as per above steps.

Shade cards and specimens of revised  artworks shall be prepared & approved.

Obsolete master artwork shall be stamped as “OBSOLETE” and shall be stored in Documentation cell for future reference.

QA ( Documentation ) shall retrieve the obsolete copies of Artwork/positives / soft copies/shade cards/print proofs / specimens / blocks from SCM, R&D (Packaging Development) and QC and shall destroy. The destruction details shall be recorded in artwork Control Record.

QA shall certify the absence of obsolete printed packaging material at printer’s location.

DOCUMENTATION :

Specimen format of customer approval record – Annexure 1.

Specimen format of approval for artwork – Annexure 2.

Specimen format of Record of softcopies – Annexure 3.

Specimen format of Artwork control  record – Annexure 4.

Annexure -3

INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH