Creating the SOP for Art Work of New Pharmaceuticals Products artwork for new pharmaceutical products involves designing the visual elements that will appear on their packaging. This includes things like the logo, brand name, dosage information, and any images or graphics. The goal is to make the packaging informative, attractive, and compliant with regulations, while also reflecting the brand’s identity. Think of it as designing the face of the product that customers will see on the shelves.
INTRODUCTION
The artwork serves multiple vital functions. Firstly, it communicates essential information to healthcare professionals and consumers, ensuring safe and effective use of the medication. Secondly, it plays a significant role in brand recognition and differentiation, helping the product stand out in a crowded marketplace. Additionally, the artwork must comply with strict regulatory requirements, ensuring that it meets legal standards and accurately represents the product’s characteristics.
Creating pharmaceutical artwork requires a delicate balance between creativity, precision, and adherence to regulations. It involves collaboration between various stakeholders, including graphic designers, regulatory experts, marketing teams, and pharmaceutical professionals. Through meticulous attention to detail and a focus on quality, the artwork contributes to the overall success of the product, fostering trust and confidence among users.
SOP for Art Work of New Pharmaceuticals Products
The printing matter, size, colour scheme, etc. used for materials for packaging of finished products are known as art work for that product.
Art work for primary materials.
The printing matter, size, colour scheme, etc. used for primary materials including PVC/ PVDC, Aluminium foil, Glass bottles, Plastic containers, etc. for packaging of finished products are known as primary material art work for that product.
Art work for Secondary materials:
The printing matter, size, colour scheme, etc. used for secondary materials including Unit packs, Mini packs, Labels, Leaflets etc. for packaging of finished products are known as secondary material art work for that product.
Art work for tertiary materials:
The printing matter, size, colour scheme, etc. used for tertiary materials including Corrugated cartons, Master cartons, Adhesive tapes etc. for packaging of finished products are known as tertiary material art work for that product.
Promotional Material:
It is originated by the marketing division and after the final approval of medical advisor, Manager Regulatory Affairs, Q.C. Manager, Production Manager and Marketing Manager sent to the printer for printing, before getting printed final printing a final proof should be got approval by the Q.C. Department.
PREPARATION OF ART WORK
Art work for required material is prepared and designed by the Quality Control Department. For example, for preparation of unit pack of a particular product, printing matter, size of the unit pack, colour scheme and other requirements are prepared and designed by the analyst of Quality Control Department and approved by the Quality Control Manager.
APPROVAL PROCEDURE OF ART WORK
After preparation of required art work by the analyst of Quality Control Department, an other senior Analyst will check the draft and take approval by the Quality Control Manager, art work is send to the Production Manager, Quality Assurance manager, Marketing Manager, and Regulatory Affairs Manager for further approval, comments and remarks if any.
After necessary corrections recommended by the above authorities, art work is sent to the printer for printing and a copy of art work signed by the above authorities is attached in art work file of that product. Before final printing draft is checked by Analyst, Senior Analyst and finally by Q.C.M. with their signature on this. After complete corrections of mistakes and approved size, colour scheme, quality of paper, printing quality, order is placed for printing from purchase department after the approval of Q.C. Manager.
CHANGE IN ART WORK OF RUNNING PRODUCTS
If any change is required in art work of running products for marketing requirements or due to other technical reasons, name of authority indicating the change required to be done is entered in respective file of that art work.
Mentioned changing proposals are discussed in a meeting of responsible authorities i.e. Quality Control Manager, Production Manager, Quality Assurance Manager, Marketing Manager and Regulatory Affairs Manager. If it is decided to change in art work, a copy of decision of change signed by above responsible authorities is attached in respective file of art work and order is forwarded to printer for required change in art work in written by the signs of above responsible authorities SOP for Art Work of New Pharmaceuticals Products
STANDARD ART WORK FILE
A printed art work file containing all printed packaging materials is maintained by the Quality Control Department for comparison of colour scheme, printing matter, design and other required parameters.
When Quality Control Departments receives any sample of printed packaging material, its parameters first of all it is compared with standard sample, which is attached in standard art work file.
If all parameters are according to the standard then it is released for productions use otherwise it is rejected.
ARCHIVING
The original SOPs is to be archived in such a way that they are protected from unauthorized use. It is stored on computer in which a priority system is established that allows access only to members of the Quality Control Department (including persons authorized by them). Storage of SOPs in the computer network is permitted under strict adherence to the rights of access and the original print of SOP’s will be store for 5 years in Quality Control Manager office.
TRAINING
Periodical Training:
The staff, that is responsible for performance of this operating instruction, has to be taught demonstrably about the content of this SOP together with the GMP training once in a year.
Training for New Employees:
Before starting with the job, the employee has to be taught demonstrably about the content of this SOP.