SOP for Handling of Artwork in Pharma Packaging

In short: This is an example SOP showing how a pharma manufacturing site can prepare, approve, issue, revise, retrieve and destroy artwork for printed packaging materials such as labels, cartons and leaflets. It is for QA, packaging, marketing, regulatory and purchase staff. Adapt it to your own quality system; it is an illustrative template, not a regulatory text.

Why artwork control matters

Printed packaging carries the name, strength, batch details, storage conditions and warnings that patients and pharmacists rely on. A wrong or outdated artwork is a classic cause of mix-ups and recalls. GMP therefore expects tight control over printed materials:

• EU GMP Chapter 5 asks for particular attention to printed materials, secure storage, issue only by authorised persons under an approved procedure, a specific reference number for each delivery or batch of printed or primary packaging material, and destruction (with a record) of outdated or obsolete printed material (paragraphs 5.46 to 5.48).
• 21 CFR 211.122 covers receipt, storage, examination and destruction of obsolete labeling and packaging materials. 21 CFR 211.125 requires strict control of labeling issued, checking it against the master or batch record, and reconciling issued, used and returned labeling.
• In India, Rule 96 (Manner of labelling) of the Drugs Rules, 1945 lists the particulars that must appear on the label of the innermost container and on every other covering in which it is packed, such as the proper name (shown more conspicuously than any trade name) and the net content. Regulatory affairs should confirm that the text on every artwork meets the current rule.

1. Objective

To lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork.

2. Scope

This SOP applies to artwork of printed packaging materials at the manufacturing facility.

3. Responsibility

4. Procedure

The steps below are an example of in-house practice. Departments, forms and sequence will differ between sites.

4.1 Preparation and approval of artwork

1. Start artwork preparation only after QA receives the approved product intimation form (Annexure I) from the marketing head.
2. For a new product, R&D provides the technical details to QA: description and dimensions of the tablet or capsule and details of the primary packaging material (for example foil thickness or gsm).
3. R&D provides product samples to Production for developing the change-part layout or drawing. Production and QA approve the layout.
4. QA raises a request to create item codes for primary and secondary packaging materials. The item code appears on the artwork of printed packaging materials for identification.
5. QA, with marketing, collects the text matter, dimensions and specimen from the principal company (where applicable) and prepares the draft artwork using these inputs:
   • text matter, brand name, pack style, Pantone shade number and font style (marketing);
   • barcode and pharmacode;
   • dimensions (from the approved machine change part).
6. When the designer returns the artwork, QA verifies it against the specimen or specification and sends corrections to the designer.
7. After final corrections, QA sends a soft copy (PDF) to Purchase and keeps both hard and soft copies.
8. Purchase sends the approved artwork files to the vendor to prepare the positive and print proofs with a shade card.
9. On receipt of the print proof, QA verifies the text and shades. Any discrepancy is communicated through Purchase and the vendor supplies a new proof.
10. Further changes to the artwork go through the change control procedure (see SOP on change control).
11. Once the corrected proof is received, the vendor prepares the positive and four sets of print proofs for QA and Purchase.
12. For products transferred from another site, QA obtains approval from the customer or principal through marketing, electronically if agreed.
13. After customer approval and print-proof approval, QA approves the artwork and keeps the record.
14. Purchase asks the vendor for shade cards covering light, standard and dark shades. After the customer-approved shade card is received, QA gives printing approval.
15. QC (packing material) maintains the record of approved shade cards (Annexure IV). Where agreed, customer approval of the shade card by e-mail may be accepted while the physical shade cards are in transit.

For printed shippers, BOPP tape and strapping rolls (if applicable), the standard artwork given by marketing, the principal company or the licence holder is followed. Where the contract giver supplies packaging material, QC verifies it against the shade card supplied by the contract giver.

4.2 Revision, retrieval and destruction

1. Revise artwork only through change control, and assign a new item code and a new artwork version number. Typical triggers are a change in packaging specification, pack style, colour scheme, text, regulatory requirement, pharmacopoeial status or buyer requirement.
2. After QA approves the change control, the packaging function prepares the revised artwork.
3. Before the revised artwork is implemented, QA retrieves the previous version of printing plates or cylinders, CDs, shade cards, approved hard copy and print proof from the vendor through Purchase, and records it.
4. QA ensures that the previous version of these items is destroyed and records the details. QA Packaging then passes the destruction documents to location QA.
5. The revised artwork is issued to the vendor through Purchase.
6. Implementation date and the fate of stock of old printed material are decided on a documented request and confirmation from marketing, planning, regulatory or the principal. Old printed packaging material is destroyed under the respective SOP, with the disposal recorded.
7. Obsolete artwork is preserved for at least 1 year after the expiry of the last batch packed with that artwork, or longer if local law or the marketing authorisation requires. This follows the site rule that GMP records are kept at least 1 year after the expiry date of the respective product batch (EU GMP Chapter 4, paragraph 4.11; 21 CFR 211.180(a)).
8. Artwork for regulated markets is approved by the licence holder, the Qualified Person or the customer, as applicable.

5. Training

Trainer: Head QA. Trainees: all departmental and sectional heads involved.

6. Distribution

Controlled copies go to the heads of QA, QC, Marketing and Purchase. The original stays with QA.

7. Annexures

• Annexure I: Product intimation form
• Annexure II: Distribution record of artwork, print proofs and 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. Abbreviations

9. Revision history

Frequently asked questions

Who should approve a final artwork? In the example above QA gives the final approval after marketing, production, regulatory and QC have each confirmed their part. Your quality system decides the exact approvers; for regulated markets the licence holder or customer also approves.

Why is a shade card needed in addition to the print proof? The proof checks text and layout. The approved shade card gives the printer and QC a physical reference for colour, so that colour mix-ups between products or strengths can be detected at receipt.

What happens to old printing plates and old printed stock after a revision? Plates, cylinders and old proofs are retrieved and destroyed with records. Old printed stock is used or destroyed as decided under change control, and destruction is recorded.

Does the same artwork rule apply to leaflets and cartons? Yes. Any printed packaging material that carries product information falls under the same control, including inserts and printed shippers.

See also: Good documentation practices for BMR, BPR and packaging instructions, SOP for documentation control procedure and SOP for new product introduction.

References

• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 5: Production (paragraphs 5.46 to 5.48, printed packaging materials), in operation since 1 March 2015.
• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4: Documentation (paragraph 4.11, retention).
• US FDA, 21 CFR 211.122 (materials examination and usage criteria), 211.125 (labeling issuance) and 211.180(a) (record retention), as in the eCFR.
• CDSCO, The Drugs and Cosmetics Act, 1940 and Rules, 1945 (consolidated PDF, 2016), Rule 96, Manner of labelling.