Supplier Qualification in Pharmaceutical Industry

Supplier qualification is a process in which the organization assesses its suppliers regarding their licenses, authorizations, and compliance with regulatory requirements for the distribution of drug products. The organization should establish a written procedure for how suppliers are selected and evaluated, including the criteria for qualification and the period for requalification on a risk-based approach.

An effective supplier qualification program should include, but not limited to, the following:

  • Initial Screening (documents, R&D activities) 
  • Qualification Audit and Supplier Response (Through Questionnaire and/or physical audit) 
  • Management Evaluation (Data submit to upper management for evaluation)
  • Formalized Approval Process
  • On-going Performance Monitoring/ Oversight (OOT, OOS, Customer Complaints, Regulatory Inspection Results etc.)

Prior a supplier qualification following points to be considered for mitigation strategies of storage and transportation of finished drug products.

Quality manual

A quality manual is a top-level quality document for all areas of the business affected by the quality system. The quality manual contains the quality policy, quality objectives, quality system structure, and information related to the management of a specific organization. The content may also include information on inspection management, customer complaints, recalls, withdrawals and holds, corrective and preventive actions, nonconformance and change control, information about regulatory issues, and performance evaluation through quality indicators.

Standard operating procedures

SOPs are controlled documents, with document owners and approvers, effective dates, revision management, and scheduled reviews. Procedures should cover areas governed by the quality manual and should cover all aspects of the operation that may affect product quality, including handling, distribution, and all regulated activities in relation to the specific business (e.g., national and international laws). SOPs should also address actions that are performed to identify and mitigate risks. Some key components are, but not limited to, the following:

  • Corrective action/preventive action (CAPA)
  • Documentation
  • Record keeping
  • Inventory management
  • Licensing
  • Management reviews
  • Nonconforming product (for example, but not limited to, damaged or adulterated, expired, recall, suspect or illegitimate product, and temperature deviation)
  • Order processing
  • Purchasing
  • Picking
  • Packing and shipping
  • Receiving
  • Returns
  • Storage
  • Training


Labels are fundamental to material identification. For this reason, any label change should be communicated to downstream supply chain partners. Labels applied, even to small containers, should be clear, indelible, unambiguous, and permanently fixed in the format established by the manufacturer, packager, or re-packager. The shipping label should include wording or icons to emphasize storage and transportation conditions, handling requirements, and hazards. The use of symbols that are recognized by international organizations is strongly recommended.


Written agreements (e.g., quality agreement, technical agreement, service level agreement etc.) should be in place between applicable organizations involved in the supply chain. Each supply chain partner should ensure that its respective service level agreements and supporting documents cover delivery and receiving responsibilities. The use of written agreements ensures clarity and transparency, while delineating the responsibilities of each organization in the supply chain.

Read also: GMP Requirements for Supplier Qualification

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