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Supplier Qualification in Pharmaceutical Industry | USP General Chapter 〈1083〉

The manufacturers of  pharmaceuticals primarily source their required ingredients, materials, components, and services through external local and global suppliers. 

External suppliers also provide services such as research and development, manufacturing, assembly, analysis, packaging, warehousing, transportation, and distribution, etc. 

The expectations on the part of regulatory authorities, healthcare professionals (including medical practitioners, nurses, dentists, and pharmacists), and consumers are that pharmaceutical products will be fitted for their intended use and be of the required quality. 

This means that active ingredients, excipients, components, other raw materials, and packaging components used in the end product have been manufactured to the appropriate standards and comply with regulations, pharmacopeial monographs, and/or all approved specifications. 

It also means that the processes in the supply chain for a material or service will also be compliant and do not increase risks to the product. Because reliable suppliers provide benefits through established risk management processes. 

Supplier qualification is a process to systematically evaluate suppliers based on 

i) the risk to the quality of the product or service supplied; 

ii) compliance of their quality systems to applicable regulations and requirements of the supply contract or quality agreement, and 

iii) the reliability of the supplier to avoid quality deviations and shortages of components and/or products.

This chapter provides a quality risk-based approach on how to select, assess, approve, and monitor suppliers of ingredients, packaging materials, and other components and services. This chapter applies to organizations involved in identifying, selecting, assessing, approving, and monitoring suppliers of:

  • Materials (e.g., active pharmaceutical ingredients, excipients, other materials, and components)
  • Packaging materials (e.g., primary, secondary, and tertiary packaging)
  • Service providers (e.g., contract manufacturing, packaging, and repackaging; logistic providers for warehousing and transportation; software; calibration and qualification services; and analytical services)

The principles discussed in this chapter apply to the different types of suppliers for pharmaceutical manufacturing companies and compounding pharmacies, to establish supplier reliability in providing appropriate materials and services. 

In this context, the fundamental principles of supplier qualification are the same for all such organizations. However, the details depend on the type of material or service, the stage of development, and the intended use of the product. 

This general chapter will focus on the high-level elements of supplier qualification that apply to all organizations.

The chapter, now final, is divided into the following paragraphs and subsections:

1. Introduction

2. Scope

3. Supplier Qualification Life Cycle: Steps for a Supplier Qualification

4. Preparation

5. Identification and Selection of Supplier for Materials and Services

6. Evaluation and Acceptance

7. Performance Monitoring

8. Supplier Disqualification

9. Conditional Approval of an Existing Supplier

Read also: Major Stages of Generic Drug Development

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