Preparation, Approval, Issue, and Control of Artworks for labeling of Pharmaceutical products
OBJECTIVE :
To lay down the Procedure for Preparation, Approval, Issue, and Control of artworks for labeling of pharmaceutical products.
RESPONSIBILITY :
R&D(Packaging Development) to prepare the Artwork, positive 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 copies, positives / soft copies, print proofs, shade cards and blocks from the 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 colour scheme in conformance with approved regulatory submissions and customer requirements.
R&D (packaging development) shall submit the artwork to customer for the approval. R&D(Packaging development) shall record of the approval from customer in Customer approval record.
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.
For labels/cartons/foils, R&D (Packaging Development) shall make available two sets of soft copies. The soft copies shall be alloted a number. Each soft copy should contain one artwork only. The details of soft copy number & artwork number shall be mentioned on the softcopy and R&D (Packaging development) shall sign on softcopy.
The numbering of softcopies consist of seven characters, first three chracters 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.
R&D (packaging development) shall submit the approved master & user copies alongwith 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 alongwith 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 printproofs against master artwork / positive and forward to RA for approval. R&D (Packaging development) & RA shall the printproofs.
If required, R&D( Packaging development) should send the printproofs to 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 printproofs.
R&D (packaging development) shall submit the approved printproofs to QA (Documentation).
QA (Documentation) shall issue one set of approved printproofs 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 acknowledgement from the printer for receipt of printproofs.
Unauthorized photocopying of artwork is prohibited.
Shade cards approval :
R&D (packaging development) shall procure 4 sets of approved shade cards from the printer alongwith 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 of change control
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 the above steps
SCM shall retrieve the obsolete copies of artwork / softcopies / positives / shade cards / printproofs / blocks from the printer along with the revised print proofs.
The print proofs shall be approved and issued as per the above steps .
Shade cards and specimens of revised art works shall be prepared & approved as per the above steps .
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 / printproofs / 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
Forms and Records (Annexures)
Specimen format of customer approval record – Annexure 1
Specimen format of approval for art work – Annexure 2.
Specimen format of Record of softcopies – Annexure 3.
Specimen format of Artwork control record – Annexure 4.
Specimen format of Shade card – Annexure 5.
Specimen format of Specimen – Annexure 6.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure 1
Specimen format of customer approval record
Customer Approval Record
- S.No.
- Name of the artwork
- Artwork No.
- Customer
- Sent by/Date
- Approval received by/Date
Annexure 2
Specimen format of approval for artwork
- Name of the Artwork
- Customer/Market
- Actual Artwork Size
- Artwork No.
- Supersedes :
- Prepared by
- Approved by/Date
Annexure 3
Specimen format of Record of softcopies
Record of Soft Copies Product :
- S.No.
- Details of artwork in soft copy & artwork no.
- Market
- Soft copy number
- Type/No. of soft copies
- Prepared by
- Remarks
Annexure 4
Specimen format of Artwork control record
ARTWORK CONTROL RECORD
TITLE :
Artwork No.:
- Item ISSUE
- RETURN
- Copy No.
- Location
- Issued by
- Received by
- Returned by
- Destroyed by
- Destroyed on
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