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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 10
First page : ( 4879) Last page : ( 4888)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00845.X

Systems for Vendor Development in Pharmaceuticals as per Current Good Manufacturing Practices

Vasanthi1, Abhinaya N1, Muddukrishna B S2, Shrikumara3, Pai K Girish1,*

1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India

2Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India

3Manufacturing Department, Medorganics India Pvt Ltd, Mangalore, DK district, Karnataka, India

*Corresponding Author E-mail: girish.pai@manipal.edu

Online published on 24 December, 2019.

Abstract

A Pharmaceutical company has to buy a range of different components and raw materials for production from various upstream vendors. Choosing the right vendor among the existing vendors, monitoring their performance is a major challenge for Pharmaceuticals. The vendor development is an important strategic process carried out in every pharmaceutical industry in accordance with current and justifiable rules and regulations, inefficiency of which affects the quality and safety of pharmaceutical products. Even after considering it as an important process many pharmaceuticals fail to follow, due to inadequate time, price, and logistics issues. Quality Assurance and Quality Control department helps to ensure that the material supplied by the vendors meets the required specification requirements. Thus, a Quality department and supply chain considered to be right departments to choose the right vendor for the Quality of raw material for the production of a pharmaceutical product. Furthermore, the FDA (Food and drug administration) has issued several guidelines on current good manufacturing practices to assure that processes for the packaging material, raw material, labeling and storage of additives are documented and meet specification requirements to assure material purity, potency, and quality. We place the contribution in a conceptual framework that takes into consideration the diversity of supply chain situations in terms of complexity and significance; it covers up all phases of the vendor development process, from the basic definition of problems to the qualification of the potential vendor to the final selection of vendors. And also the final suitable decision methods reported in this literature to support the selection process for the vendors.

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Keywords

Vendor development, Current Good Manufacturing Practices, raw material, packaging material, vendor qualification, handling of deviation and risk assessment.

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