Artwork approval in Pharmaceuticals

1.0 OBJECTIVE

To lay down a procedure for approval of Artwork 

2.0 SCOPE

This procedure is applicable to all the Artworks used in the XXXX company.

3.0 RESPONSIBILITY

3.1 Purchase- Mediation of Artwork

3.2 Quality Control – Review of Artwork

3.3 Production- Review of Artwork

3.4 Quality Assurance- Finalization of Artwork 

4.0 PROCEDURE 

4.1  Artwork Preparation and Approval 

4.1.1 Quality Assurance department shall initiate artwork by filling details in the Specimen label annexure-1 by QA-Executive. 

4.1.2 Specimen label contains details like type of artwork, pack size, generic name, Brand name, label claim, storage conditions, warnings, precautions or indications, Mfg. Lic No. and dimensions along with manufacturer address.   

4.1.3 The Specimen label shall be reviewed by Head-QA and forward to designer. 

4.1.4 After completion of designing of artwork designed shall forward the artwork to Executive-QA. 

4.1.5 Executive-QA shall review artwork for the following details 

4.1.5.1 Generic name of the product as per license

4.1.5.2 Brand Name, if any

4.1.5.3 Brand  or generic name in Hindi

4.1.5.4 Label claim as per license copy

4.1.5.5 Indications

4.1.5.6 Storage conditions

4.1.5.7 Precautions for children

4.1.5.8 Pack size

4.1.5.9 Batch details like batch No, Mfg.Date, Exp.Date and MRP in hindi as well.

4.1.5.10 Manufacturing license number

4.1.5.11 Manufacturer address

4.1.5.12 Artwork code

4.1.5.13 Trademark or trademark pending  

4.1.6 QA shall circulate the artwork to all the departments for review and approval with Artwork/ Print proof Approval Form (Annexure-3) which shall be designer. 

4.1.7 Designer shall make the changes as per the review comments 

4.1.8 Once again QA shall circulate the artwork to all the departments for review and approval with Artwork/ Print proof Approval Form (Annexure-3). 

4.1.9 Once the corrections are completed, the artwork shall be sent for printing. 

4.1.10 The printer shall submit the print proof to QA for approval. 

4.1.11 Once Head-QA approval, labels or cartons are printed. 

4.1.12 QA shall affix the Master copy seal on one label or carton. 

4.2 Artwork Coding Procedure

4.2.1 All the artworks shall be numbered with a unique code number as described below  for parenterals

GAB/CCC/YYYY 

G stands for COMANY NAME

A stands for Type of Formulation (i.e Tablets, Powders, Liquids and Dry powder injections.

B stands for Foil, Label or Carton

CCC stands for Product code

YYYY stands year (i.e 2018)

4.2.2   All the artworks shall be numbered with a unique code number as described below  for Tablets

GAB/CCC/XX

G stands for COMANY NAME

A stands for Type of Formulation (i.e Tablets, Powders, Liquids and Dry powder injections.

B stands for Foil, Label or Carton

CCC stands for Product code

XX Stands for number of tablets per strip or blister

4.2.3    All the artworks shall be numbered with a unique code number as described below  for Liquids or Powders

GAB/CCC/XXX

G stands for COMANY NAME

A stands for Type of Formulation (i.e Tablets, Powders, Liquids and Dry powder injections.

B stands for Foil, Label or Carton

CCC stands for Product code

XXX Stands for pack size

4.2.4 All the artworks shall be numbered with a unique code number as described below  for parenterals (for Govt. Supply)

GAB/CCC/ XX /YYYY

G stands for COMANY NAME

A stands for Type of Formulation (i.e Tablets, Powders, Liquids and Dry powder injections.

B stands for Foil, Label or Carton

CCC stands for Product code

XX stands for state code in India

YYYY stands year (i.e 2018) 

4.3 Change Control

4.3.1 If any change(s) are required in the  packaging material like

4.3.1.1  Changes in Text matter

4.3.1.2  Change in statutory requirement

4.3.1.3  Change in manufacturing address

4.3.1.4  Change in colour scheme or layout

4.3.1.5  Change in size. 

4.3.2 Intimation shall be sent to the QA by the concerned department.

4.3.3 QA shall initiate the change through the change control SOP 

4.3.4 After the approval of the change the procedure for preparation and approval of the artwork and packaging material shall be followed as per above procedure.

4.3.5  The ‘Master copy’ artwork shade card available with QA shall be stamped as OBSOLETE COPY in black and shall be retained by QA for any future reference.

5.0 ABBREVIATIONS

5.1 QA-Quality Assurance

5.2 SOP- Standard Operating Procedure        

6.0  ANNEXURES

6.1 Annexure 1: Specimen Label

6.2 Annexure 2: Artwork/ Print proof Approval Form