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1.0 OBJECTIVE
To provide guidelines for preparation, approval & maintenance of new artwork or for changing the existing one, incorporating necessary requirements of Local Drugs Authority or any other regulatory authority, pharmacopoeia or marketing requirements.
2.0 SCOPE
This procedure is applicable for preparation, approval & maintenance of artworks for all the products manufactured and marketed by (Company Name).
3.0 RESPONSIBILITIES
3.1 Strategic Brand Management (SBM) / International Marketing (IMT) department shall be responsible for ensuring that the text and graphic details of printed packaging component artwork are correct & complaint with the market requirement.
3.2 Quality Assurance Manager shall be responsible for providing technical information to SBM/IMT for preparation of artworks.
3.3 Manager R & D, Manager SBM/IMT, Manager Production, Manager QA and Manager QC shall be jointly responsible for verification of pack design and size and related text matter.
3.4 Head of QA shall be responsible for final approval of artworks.
4.0 ACCOUNTABILITY
4.1 Head of Quality, Manager, Strategic Brand Management (SBM) & Manager, International Marketing (IMT).
5.0 PRECAUTIONS
5.1 Obsolete plate or cylinder should be withdrawn from the suppliers (printers) to avoid mix-ups.
5.2 Incase of preparation of a new artwork, change control must be raised.
6.0 PROCEDURE
6.1 Preparation of Artwork for new products
6.1.1 SBM / IMT shall supply a written or electronic artwork specification to artist / artwork studio of Desktop Publication (DTP) section of Beximco Pharmaceuticals Limited for artwork designing. For designing artwork with foreign languages IMT should send the primary artwork design to the regulatory department of the respective market in electronic format for their designing as per their artwork specification.
6.1.2 Quality Assurance shall provide technical information to SBM / IMT for preparation of artwork design.
6.1.3 SBM / IMT shall give information regarding the pack size, text matter, design etc and based on these, the responsible artist shall prepare and submit a draft artwork of the packing material.
6.1.4 If the design is not suggested by the SBM / IMT department, the artist shall prepare and submit alternate designs from which SBM / IMT shall select one.
6.1.5 SBM / IMT shall check the first draft printout of the artwork against artwork specification given to artist / artwork studio.
6.1.6 If the draft printout is satisfactory, SBM / IMT shall fill the relevant details in Proof /Artwork checking record (Annexure –I) & sign with comment (if any) as checked. If the draft artwork is found not meeting the desired design, SBM/IMT shall get it corrected from the printer/design department.
6.1.7 SBM /Marketing shall send duly checked draft printout of the artwork along with Annexure-I to Quality Assurance (QA).
6.1.8 QA shall maintain all receipt / issue Artwork details in a register (Annexure-II).
6.1.9 Draft printout of artwork shall be routed through Manager R & D, Manager QA, Manager QC and Head of Production for review and comment.
6.1.10 QA & QC shall check the draft artwork against the check-list (Annexure-VI).
6.1.11 All concerned shall put comments (if any) into attached Annexure – I and sign as checked.
6.1.12 If the draft printout of the artwork requires correction (s) in text matter the same shall be forwarded to SBM / IMT for correction in text matter and a fresh draft proof shall be initiated again. In this case, steps from 6.1.3 to be followed again.
6.1.13 If the draft printout of the artwork is found correct, Head of Quality will give approval on it as final artwork and then QA shall make two (2) sets of photocopies.
6.1.14 QA shall send back the original approved copy to SBM / IMT (as applicable) and keep the record in Artwork Movement Register (Annexure-III) only by mentioning the department name (i.e. IMT or SBM). QA shall distribute one photocopy of the approved artwork to QC and the other will be retained with QA. The QC officer receiving the copy of the artwork shall sign & date in the Artwork Movement Register (Annexure-III).
6.1.15 After receiving the approved artwork from QA, SBM / IMT shall give it to Beximco design department / Artwork studio for preparation of positive. However, the responsibility of the Artwork will remain with SBM/IMT.
6.1.16 Based on the approved artwork, Beximco design department / Artwork studio will prepare the positive for the local printers. In case of imported materials, the supplier’s design department / artwork studio will prepare the positive for themselves.
6.1.17 SBM / IMT shall collect the positive (s) from artwork studio (both Beximco & supplier) and send one copy of positive of each item to the selected printer for printing and another to QC for checking the samples of supplied lots for release. During sending the positive to QC, SBM/IMT shall also send the Printer Information (Annexure-VII) which will be kept in QA file. After receiving the printer information form, QA shall record the printer’s name in the Artwork Movement Register (Annexure-III).
6.1.18 At any time, if SBM or IMT changes the printer, i.e. give the same positive to another printer, the printer information form shall be filled by SBM or IMT and send to QA/QC. In that case, QA shall re-enter the information in the Artwork Movement
6.1.19 Register against the Artwork code of the material and preserve the printer information form in the file.
6.1.19 After receiving the positive, QC shall check it against the copy of the approved artwork. If it found satisfactory QC shall retain the positives for checking the texts of the routinely supplied lot.
6.1.20 If the positive found not complying with the approved artwork, it shall be returned to SBM/IMT for correction and follow step 6.1.16 and 6.1.17.
6.2 Preparation of Artwork In Case of Change in existing Artwork
6.2.1 The existing artwork shall be revised or changed under following conditions:
6.2.1.1 Change in design or pack size.
6.2.1.2 Change in address or license no.
6.2.1.3 Change in pharmacopoeia status of the product.
6.2.1.4 Incorporating new statutory requirements/ price change.
6.2.2 The required change shall be intimated by SBM / IMT.
6.2.3 In case of change in pharmacopoeia status & regulatory requirements, QA shall inform SBM / IMT for required change.
6.2.4 SBM / IMT or QA shall initiate the necessary change in the artwork through raising change control. After the change control being approved, depending on the nature of the change the artwork shall be modified by IMT/SBM carrying out minor adjustments in the text matter, layout or changing the design by sending it to the artist.
6.2.5 On receipt of corrected (for change) artwork, SBM / IMT shall start from step 6.1.3 and will continue to 6.1.20.
6.3 Checking of Printer’s Proof & Approval
6.3.1 After receiving the positive or approved artwork, the printer / supplier (local / overseas) shall print proof samples.
6.3.2 The printer shall provide samples of the printed proof (e.g. foil, carton, leaflet etc.) as per the designed artwork to SBM / IMT.
6.3.3 SBM / IMT department shall check & approve the colour & layout. Quality of the paper on which proof is taken shall be the one, which is decided for regular use by SBM/IMT.
6.3.4 SBM / IMT shall forward minimum 4 copies of printed proof with 4 shade cards to QA/QC for checking the text.
6.3.5 Manager QA & Manager QC or their designee shall check the text of the printed proof against the approved artwork/positive and will provide feedback on the shade cards for text only.
6.3.6 If the texts found satisfactory, three shade cards will be sent back to SBM / IMT department with approval and one shade card will be retained with QC. In case there is error in text, all shade cards will be sent back to SBM / IMT department with comments. In that case SBM will follow step 6.3.1 to 6.3.5.
6.3.7 SBM / IMT department will forward one approved shade card to the supplier, one to purchase department and another will be retained with them.
6.3.8 Upon receiving the approved (for colour, layout & text) shade card, the supplier shall print final samples exactly meeting with the full specifications and submit sufficient quantity of samples through purchase department for QC testing (for leaflet, carton & self adhesive labels, minimum 10 samples of each) and final approval. For cartons used in the auto -cartons, machine trial will also be done before final approval of cartons.
6.3.9 In case of foil, a roll exactly meeting with the agreed specifications should be supplied by the printer/supplier. This foil quantity will be used for QC testing (to verify against approved foil spec) and machine trial (to check leakage).
6.3.10 In case BPL wants to develop multiple product foils from same supplier, after approval of shade cards, there is no need of sending a roll for every product to carry out machine trial. In that case number of foil rolls can be reduced, but 2-3 feet sample for each product must be submitted for QC testing.
6.3.11 Once the printed, finally submitted sample is found satisfactory, QC will issue Certificate of Analysis (CoA) and provide to Purchase department to proceed forward. A specimen sample from the approved sample will be kept at QC as reference sample.
6.4 Purchase of Materials & Management of Artwork
6.4.1 After getting the approval from QC (CoA), purchase department will place purchase order for commercial supply of foils (initially a minimum quantity) which shall be agreed between BPL & the supplier. If the first commercial lot runs satisfactory, the next commercial lot will follow.
6.4.2 After satisfactory consumption of 3 commercial foil lots, BPL QA and the Supplier QA will sign a technical terms of supply (TTS) agreement for further foil supply.
6.4.3 In case of leaflet, carton & self-adhesive label, before supply of each commercial lot, the supplier shall send proof copies / samples to QC. The proof copies / samples shall be checked by QC, QA & Production and shall be given approval if found satisfactory using Annexure – V.
6.4.4 Based on the approval on the proof copies or samples, supplier will supply packaging material lot to BPL warehouse. QC will perform sampling & testing and will take disposition decision.
6.4.5 QC will subsequently, from the supplied packaging material lots of leaflet, carton & self-adhesive label, retain samples for future reference.
6.4.6 In case of change in the artwork and subsequent change in the plate or cylinder, QA and purchase department jointly shall be responsible for withdrawing these from the printers as well as other sites. QA shall identify the respective printer from the Artwork Movement Register.
6.4.7 The withdrawal & destruction record of the positives & destruction of plate / cylinder shall be maintained in the Withdrawal & Destruction Register (Annexure – IV).
6.4.8 Change control procedure shall be applied to any artwork amendment, however trivial.
6.4.9 During withdrawal / destruction of the positives from the printer, the responsible person shall also ensure destruction of the corresponding obsolete plates or cylinders. No reworking of existing cylinder is acceptable to incorporate changes. New cylinder shall be made.
6.4.10 QA and Purchase department shall be responsible for withdrawal of obsolete cylinders/plates from printer (supplier) end.
6.4.11 Destruction of such obsolete items (cylinders, plates & artworks) at printer end shall be done in presence of QA/purchase.
6.4.12 The destruction of positives at the end of QC, IMT/SBM or purchase (if any) shall be done by QA with prior approval from QA Head. The record of destruction shall be maintained in withdrawal & destruction record (Annexure-IV).
6.4.13 In case of two different dimension artworks (foil with different width), separate artwork procedure shall be followed for each foil.
6.4.14 Artwork must be handled, transmitted & stored in a secure manner to avoid any possibility of corruption or unauthorized use.
6.4.15 For use of printed packaging material at the end of third party contract manufacturer, the artwork design will be done jointly by SBM/IMT & the regulatory department of the respective market.
6.4.16 The approved artwork design will then be used by the third party contract manufacturer for getting the printed packaging material from their approved printer (overseas).
6.4.17 In case of a local third party contract manufacturer, Beximco will supply the printed packaging materials.
