SOP on Artwork Design and Approval

SOP on Artwork Design and Approval

Objective:

To lay down a procedure for artwork design and approval (of Printed packaging materials).

Scope:

This Standard Operating Procedure is applicable to all drug products manufactured and marketed by Pharmaceutical company.

Responsibility:

For Artwork development and approval system of Export markets

• Head Marketing shall be responsible for providing the Packaging Development module and PDF files to RA department along with approval certificate of approval from concerned MOH or equivalent authority.
• Head RA/ Designee shall forward the packaging module along with CDR and PDF files to Head-QA for scrutiny.
• Head QA/ designee shall finally forward the packaging module form along with CDR files and PDF files to packaging development for development of artworks.
• Packaging development shall be responsible for designing the artworks as per packaging module and circulating the artworks for approval to all concerned departmental personnel after allotting the item code, dimension and bar code on the artworks.
• Head-RA/ designee shall be responsible for verification of text matter/ label claim/ Brand Name/ Generic Name of the artwork with respect to the regulatory requirements/ domestic WHO requirements or as per the registered product information.
• Head- Packaging Development or designee shall be responsible for verification of the dimensions, bar code and item code provided by the officer packaging development.
• Head -Packaging Development or designee shall also be responsible for approval of layouts in case of new products or for new change parts or pack.
• Head- Production shall be responsible for verifying the artwork with respect to the machine suitability or Dimensions of the artwork.
• Head- Marketing/ Designee shall be responsible for verification of text matter of the artworks with respect to the regulatory authorities, design, colour scheme and brand name. In case of text with vernacular language Marketing has to ensure the complete text matter of the artwork (if text contains text in English and vernacular language marketing has to ensure the text matter of both languages).
• Head- MM/ Designee shall be responsible for verification of number of colours and resolving vendor queries on the artwork.
• Head QA shall be responsible for final approval of artworks after reviewing with respect to the comments of all departments.

Auditing in the Pharmaceuticals Industry

Artwork development and approval system for Domestic market

• Head FRD shall be responsible for preparation of facsimile label for the development of artwork of new products, verification of formula information, label claim and storage condition mentioned over artworks of a component and shall send the facsimile label to RA for initial approval of the development process.
• Head RA shall be responsible for approving the facsimile label and forwarding the same to QA department.
• Responsibilities for Artwork approval process remain same as per Export market.

Approval System of PI for Domestic Market

• Head CR/Designee shall be responsible for providing text matter of PI to PDD.
• Head PDD/Designee shall be responsible circulation and taking approval on the artwork of PI from all concerned departments.
• Head QA/Designee shall be responsible for final approval with respect to comments from relevant departments on the artwork of PI.

Approval of Shade Cards/ Hand pulls / Print proofs/ Bromides/Negatives

• Head MM/ Designee shall be responsible for sending the shade cards/ Print proofs/Negatives of the concerned packaging material to Head PDD /Designee (in case of new change part and new pack design only), Head QA/Designee (In case of shade cards) and Head Marketing for approval of Negatives of packaging material (In case of artworks with vernacular language) for approval on layout/ dimensions.
• After approval of Negatives from Head Marketing, MM shall send one set of negative to QA department.
• Head QA/ Designee shall be responsible for final approval and distribution of Shade cards/ Bromides/ Negatives for shades.

Abbreviations and Definitions

PI                    :           Package Insert.

PDD                :           Packaging Development

QC                  :           Quality Control

QA                  :           Quality Assurance

RA                  :           Regulatory Affairs

CR                  :           Clinical Research

FRD                :           Formulations Research and Development

MM                 :          Material Management

API                  :          Active Pharmaceutical Ingredients

RPI                  :           Registered Product information

Printed Packaging Material: Foils, Cartons, Corrugated boxes, Package Insert Cache cover etc. with printed text matter

Print proof    :       Artwork generated by vendor (Soft copy / printed copy) as per approved artwork.

Procedure

Designing / Development of Artworks

• Head Marketing shall provide the duly filled “Packaging development Module” to RA as per Annexure -I.
• The “Packaging development module” shall contain a detailed information
  • Packaging components of Particular product
  • Brand Name, Generic Name, Color Scheme, Pack size requirement for Primary, Secondary and Tertiary packs, special packaging requirement etc.

• Respective Business Head shall also provide Brand and Company Logo and color scheme or design of carton and foil to PDD.

• RA shall ensure the compliance of requirement as per the regulatory and labeling guidelines of the respective countries/markets.
  • It shall comprise the following but not limited to Brand Name, Manufacturing License number, Pharmacopoeial status, product code and Label claim, Dosage, Schedule Warning as per Drugs and Cosmetics Act 1940 and / or country specific requirement, packing of drugs, and Registration Number.
  • For Foreign languages artworks, the text matter approved and stamped by the MOH shall be considered as final.
• RA then forwards the same packaging module to QA for scrutiny along with comments on the packaging module.
• After evaluation of the packaging module Head- Quality Assurance or designee shall forward the Packaging module to Head- Packaging Development or designee for artwork development and approval process.

Note: If QA is not satisfied with packaging module then QA shall send the packaging module back to the Marketing/ RA.

• PDD shall initiate the designing of artwork after receiving the relevant information from QA and shall circulate to all departments for comments and approval.
• PDD shall initiate the artwork design by providing dimensions, item codes and barcodes.
• The proposed artwork can be circulated parallel to all departments for comments and approval, through electronic mode of communication to expedite the approval process.
• In case of new products, Head FRD/ Designee shall prepare the facsimile label and shall send the same for approval to Head RA/Designee for his comments.
• After reviewing the facsimile label Head RA/ Designee shall send the facsimile label along with pre-requisite to Head QA/ Designee for artwork development.
• Finally Head QA/ Designee shall forward the same to PDD for artwork development.

Approval of Artworks

• • PDD department shall circulate the proposed artworks to the following departments in the order of sequence or parallel to all departments.
    • FRD
    • Marketing
    • Clinical Research (Wherever applicable)
    • Production
    • Regulatory Affairs.
    • Material Management, and
    • Quality Assurance
  • Head, Packaging development or designee shall verify the dimensions, item code and bar code (wherever applicable) of the artwork and sign in the respective column in the artwork approval sheet with comments.
  • After approval from Head-Packaging Development scientist PDD shall forward the artworks to Head, FRD or designee for his relevant comments with respect to label claim, dosage, storage condition, colour and excipients used in the formulation.

Note: Head, FRD or Designee shall verify the details as per the manufacturing License of the Product and/or Product development report.

• After putting his comments on the approval sheet Head, FRD shall resend the artworks to Scientist, PDD.
• Marketing shall check the artworks for
  • Design, colour scheme, Company and Brand design, text matter (Where the text is  in language other than Hindi/ English and English).

Note: If the text is in other language, marketing shall share the same with country and seek the approval. Marketing shall approve the artwork on the basis of approval from the country.

• Pack Size, Placement of contents and overall design.

• After comments from Marketing, Scientist PDD shall forward the proposed artworks to Clinical research department for their evaluation.
  • Head CR or designee shall check the dosage, indication, contraindications and overall accuracy of the text matter and give their comments.
• After approval from Clinical Research, Scientist PDD shall forward the artworks to Production department for their comments.
  • Head- Production or designee shall check the proposed artworks with respect to the spacing provided for the Batch coding details, Machinability, online printing/ coding issues, Machine change parts/ labeling machine compatibility and record their comments on the artwork approval sheet.
• After taking consent from Production department, officer PDD shall forward the proposed artworks to Regulatory Affairs department for their comment.
• Head RA or Designee shall check the proposed artworks with respect to the manufacturing license available and check the proposed artwork for following but not limited to these details.
  • Label Claim
  • Regulatory / Drug and cosmetic act requirements/ other country specific labeling details.
  • Approval on text (English Hindi/ English or any other vernacular text)
  • Manufacturing License number and the site of manufacturing.
  • Storage conditions, Shelf life and Pack size as per the RPI and record their comments.
• After comment from RA, Scientist PDD shall forward the proposed artworks to MM department.
  • Head- MM or designee shall check the details like number of colours and the vendor related issues and give their comments and send the same back to PDD.
• After taking approval from all the concerned departments Head PDD or designee shall re-circulate the artworks (If proposed artwork has any comment from the departments) to all departments for their final approval.
• After getting approval from all departments, Head-PDD or Designee shall forward the proposed artworks to Head QA or designee for final approval on the artworks.
• QA personnel shall check the artworks with respect to the comments given by various departments and on the basis of the comments/ recommendation shall approve the artwork.
• QA personnel shall put a stamp on the artwork in blue colour having following details on the artwork followed by a serial number as XXX/YY.

Stamp shall have the following details:

• APPROVED ARTWORK
• S.No…………………………………
• Approved By………………………..
• Date…………………………………
• Department : QA

XXX denotes the serial number as 001,002,003 to 999.

Followed by slash “/”.

YY denoted the financial year e.g. 16 for April 2022 to March 2023.

After putting serial number to the artwork QA personnel shall put his/her signature with date in the respective area.

After approving the artwork QA personnel shall keep the original copy of the approved artwork with documentation cell with “Master Copy” stamp and circulate the controlled copies of the artwork to MM, QC, RA and R&D for their records (Distribution of controlled copies shall be done in accordance with SOP of document and data control).

Note: In case the printing is to be done on both sides of the foil then same item code shall be assigned to both sides.

• Once the artwork of any component is approved, PDD shall provide the artwork to MM for printing.
• Any change in the approved artwork shall be done through change control procedure.
• In case of packaging components having foreign language text, a copy of artwork approved from MOH shall be given by International marketing and MM shall prepare a negative of the same and shall send the negative to marketing for approval (negative shall be made only in case where text contains vernacular language) and after approval of negative MM shall send the negative to Quality Assurance department.
• Officer QA shall approve the negative by stamping and distribute the same to QC department for imposing purpose. It shall be distributed for comparing the proposed artwork.
• MM shall send the artwork to vendor for printing of shade card.
• The vendor on receipt of artwork shall generate print proof and / or hand-pulls and send to MM for approval.
• MM shall forward the vendor generated print proof and / or hand-pulls to marketing for colour shade and colour scheme approval.
• Later vendor generated print proof/ Bromides and / or hand-pulls shall be sent to PDD for layout and dimension approval. Hand pulls shall be sent to PDD approval only for new products / new change parts / new pack style. For existing products with existing pack layout, even if there is revision of artwork, hand pull approval shall not be done.
• The vendor on receipt of approved print proof and / or hand-pulls shall send shade card (three copies) for approval to QA.
• Executive / Officer, QA shall review the shade card with respect to approved artwork and Head, QA shall finally approve the shade card.
• QA shall retain one shade card as MASTER COPY and distribute the other two shade cards as controlled copies to QC and MM
• MM shall forward the approved shade card to vendor for final printing.
• Shade cards shall be valid preferably two years from its approval date and new set of shade cards shall be provided by the vendors for approval of any consignment after that period.

Package Insert (PI)

• • Clinical research shall be responsible for the preparation, and circulation of PI to all concerned departments for comments. After incorporation of comments Clinical research shall forward the PI to RA.
  • R&D shall provide the information regarding Incompatibilities (If any) to Clinical research for preparation and approval of PI.
  • RA shall provide the following information to Clinical research for preparation and approval of PI.
    • Proprietary name (if any)
    • Generic Name
    • Composition and strengths with dosage form,
    • Countries intended for filing
    • Local innovator pack insert  (if available)
    • Packaging storage and handling information
    • Shelf life
  • Clinical research shall provide the approved PI along with approved hardcopy and softcopy to PDD.
  • IPR shall evaluate the patent related information of the product w.r.t packaging insert and give the comments.
  • PDD shall compose the text matter of Package Insert in a specific size.
  • A copy of composed text matter shall be forwarded to clinical research, FRD, RA, Marketing, MM for their comments and approval.
  • After receiving the approved PI from all concerned departments Packaging development shall forward the same to QA for final disposition, logging and distribution.
  • QA shall approve the final text matter of PI with approved stamp and signature on the artwork sheet and retain in QA.
  • QA shall distribute controlled copies of approved PI to QC, MM, RA and Clinical Research.
  • Any change in the approved PI shall follow the change control procedure as per SOP .
• Artwork approval process for Contract Manufacturing
• In case of Contract manufacturing locations, the artwork approval system is as per the system mentioned below.
• BD/ Marketing shall generate the artworks for the product and shall circulate the artworks for approval/ comments to RA and QA.
• After taking comments on the artworks Head Marketing / Business development shall modify the artworks and takes re-approval from the concerned departments (Refer Annexure-4 for details).
• After taking approval from all departments Head BD/ Marketing shall forward the artworks to Head- QA.

Note: Each concerned department shall check the artwork on their behalf as per the checklist (Annexure-3) as applicable, before giving their final approval on artwork approval sheet. The checklist can be used for reference only.  The checklist features can go beyond the information contained in the checklist but within the framework of the regulatory guidelines (Wherever applicable).

Forms and Records

• Packaging Development Module             : Annexure-1
• Checklist for approval of artworks : Annexure-2

Distribution

• Master Copy :   Quality Assurance)
• Controlled Copies : Materials Management, Packaging Design, Packaging Development, R&D, Regulatory Affairs,  Marketing/Business Development, Clinical Research, Production, Quality Control, Quality Assurance,

History

• Date
• Revision Number
• Reason for Revision

Annexure -I

PACKAGING DEVELOPMENT MODULE

Particulars

• Brand Name indicating
• Writing style
• Font
• Size
• Visual/Logo
• Registration status for example TM or Registered. If any
• Generic Name
• Composition label claim/ Product code (as to be provided on carton/foil) label etc.
• Brand positioning statement
• Colour scheme
• Label
• Foil
• Carton
• Catch cover etc.
• Shipper (Kraft paper/Corrugated boxes)

1. Virgin/Kraft paper
2. Semi Virgin /Recycled

• Dosage form
• Injection

1. Amber glass bottle/Ampoule/Vial
2. Clear glass bottle/Ampoule /Vial

• Auto destructible pre-filled injection device
• Liquid Amber/Clear glass bottle
• Tablet
• Capsule
• Ointment/External application
• Colour, shape, size to be specified (for all)
• Stock keeping units (SKU) :0.5ml,1ml,5ml,10ml,30ml,50ml,60ml,100ml,200ml,450ml,1’s,2’s,4’s,1 x 10’s,2 x 10’s,3 x 10’s , 5 x 10
• Any other reference product packaging
• Ampoules/Clear glass /Amber
• Tablets/Capsules, Aluminium blister, Alu-Alu strip, alu/pvc/blister alu/pvc/pvdc //blister, glassing, poly, others
• Suggested final pack
• No. of cap/tablets in one strip or ampoule in one tray
• No. of strips/ampoules in a carton
• No. of carton in a box.
• Preferred packing in case of individual packs, whether outer carton/catch cover and shipper is required or not.
• Special printing requirements (for example – company, brand logo imprint)
• Tablet
• Capsule
• Injection
• Bottle and Capsules, liquid
• Blister
• Aluminium strip
• Carton
• Shipper
• Auto destructible prefilled injection device
• Any special packaging requirement (to be enclosed in the pack)
• Patient Education leaflet
• Membership cards
• Customer relationship management schemes
• Product usage instructions
• Shrink wrap peel off.
• Package insert
• Medical claims on the label/foil/carton
• Warnings
• Dosage instructions
• Storage conditions
• Baby shipper & Mother Shipper (Preferred no. of packs)
• Pricing
• MRP Rupees. (Inclusive of all taxes) per unit pack
• Discount structure
• Levies (any charges imposed)
• Bonus offers
• Copyright statements
• Product patent details.

Note:

1. To be submitted along with the Marketing plan.
2. To be updated every quarter within 3 months prior notice for any revision (upward or downward)
3. For submission to Production planning department with minimum 6 months advance notice.
4. Pharmacopoeia status, shelf life required, Mfg. License no., any additional requirement, if any.

Annexure-II – Requirements as per D&C Act 1940 & Rules 1945 (Part I)

1.

a) Generic name is followed by Brand name for domestic market.

b) Generic name of the product is more conspicuous than the brand name.

2.Generic Drug Product is official in Pharmacopoeia status is mentioned on the label

3.Generic Drug Product is included in National formulary of India and the name or synonym specified therein followed by the letters ‘N.F.I.’.

4.A correct statement of net contents in terms of weight, measure, volume, number of units of contents, number of units of activity as the case is mentioned.

(This may not be applicable to pharmacopoeia preparations where the composition of such preparation is specified in respective pharmacopoeia  and to preparation included in NFI)

5.The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured are available

6. The batch number being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.

7.The figure representing the manufacturing license number being preceded by the words “Manufacturing License Number” or “Mfg. Lic. No.” or “M.L.” is mentioned.

Manufacturing license no. is

8. Manufacturing date and expiry date are available

9. Contents of active ingredients expressed

For oral liquid preparations :

I. Contents of active ingredients are given in terms of content per single dose or the dose being indicated in 5 milliliters

ii. Where the dose is below 5 milliliters the contents of active ingredients may be expressed in terms of milliliter or fraction thereof.

iii. Where the single dose is more than 5 milliliters, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority

For Liquid Parenteral :

i.For liquid parenteral preparations ready for administration, in terms of 1 milliliter or percentage by volume or per dose in the case of a single dose container.

ii The preparation is contained in an ampoule then the composition is shown on the label shall bear

• Drugs in solid form intended for parenteral administration is given in terms of units or weight /mg or weight/gm
• Tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be

For other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or milliliters as the case may be

10.Drug product intended for distribution to the medical profession as a free sample is labeled as Physician’s Sample – Not to be Sold’.

11.If the preparation contains not less than 3 per cent by volume of alcohol the quantity of alcohol is stated in terms of the average percentage by volume of absolute alcohol in the finished products

12.A conspicuous red vertical line (min. 1 mm in width) on the left side running throughout the body of the label without disturbing other contents of the matter is present for Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under schedules ‘G’, ‘H’ and ‘X’.

• This shall not be applicable for preparation intended for animal treatment, preparations intended for external use, Ophthalmic preparations and ear drops, and sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use

13.The drug is specified in :

• Schedule G
• Schedule H drug
• Schedule X drug

14.For medicine for internal use  :

1. The substance specified in Schedule G is labeled with the words “Caution – it is dangerous to take this preparation except under medical supervision”-conspicuously printed and surrounded by a line with which there shall be no other words.
2. The substance  specified in schedule H is labeled with symbol Rx on the left top corner of the label and is bearing following words “Schedule H drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”,

iii. The substance specified in Schedule X is labeled with symbol XRx which shall be red and conspicuously displayed on the left top corner of the label, and be also labeled with the following words. “Schedule X drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”.

15.The container of a medicine prepared for treatment of human ailments if contains

• Industrial methylated spirit & indicated this fact on the label · Labelled as For External use only.

16. Packing of Drug:

1. The pack sizes for drugs meant for retail sale are in Schedule – P1 If Yes Pack Size is as per Schedule-P1

ii.For pack size not covered in Schedule-P1

1. Pack sizes for tablets/ capsules

• The number of tablets / capsules are less than 10

Ø In this case packing is made by integral number)

• The number of tablets / capsules are more than 10

Ø In such case pack sizes of tablets/ capsules is in multiple of 5

• Pack size for pediatric liquid oral preparation is 30 ml
• For other liquid oral preparations pack sizes are
• Pack sizes for pediatric oral drops are
• Pack sizes for Eye / Ear / Nasal drops

·  Pack sizes for Eye ointment are

17. a) Storage conditions are mentioned and as per the facsimile label approved by R&D.

b)Storage conditions full fill the minimum Pharmacopoeia requirements, if applicable.

c)Shall comply with D&C act and other applicable guidelines

18. Any special warning / instructions e.g. children warning are mentioned.

ii.Complies with the requirements of Rule No. 106 “Disease which a drug may not purport to prevent or cure”.

19.Dosage is mentioned on the label

20.a) The text for maximum retail price is mentioned

21.Check and verify the address of manufacturing location from license. Check the spellings.

22.Check and verify label claim and composition from Technical Direction or Facsimile label or license.

1.  Check the tablet’s description w.r.t.  coated, film coated, enteric coated, dispersible, flavored etc.
2. Check ‘colours’ are mentioned.

23.Check the barcode, wherever applicable.

24.Check the item code of packaging components code and verify from BPR (Pkg.)

25.Check the company logo and its colour.

26.Check the company address w.r.t. “Manufactured in India by:” “Manufactured by:” “Marketed by:” In case of Loan license products, the address should be written as follows: Manufactured by, At: (Address of the manufacturing site).

27.Check the actual size of packaging component from R&D or BPR (Pkg.) & refer respective specification, wherever applicable.

28.Check the warning or special warning, if applicable.

29.Check the Instructions or route of administration as per the different dosage form requirements: e.g.

“Shake well before use”

“For IM/IV use”

“Replace the cap tightly after use”

“Constitute the solution as recommended” etc.

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