Vendor Management.
For all your vendor risk and supplier qualification needs.

What is Vendor Management?

Terminology.

The terms Vendor and Vendor Management within the pharmaceutical industry refer to external entities or suppliers that provide goods, materials, services, or specialized expertise or technology at any point throughout the entire lifecycle of pharmaceutical products, from development through to manufacture and distribution.

Vendors are an integral part of the pharmaceutical supply chain, performing a range of specific functions.

Within GCP and GVP/VGVP the term Vendor Management is widely used, and in GMP and GDP the term Supplier Qualification is common, but regardless of naming and exact scope, all vendors/suppliers present a range of opportunities and risks to safety, operations, finance, and reputation.

The area of Vendor Management is therefore of vital importance and above all for patient safety and compliance.

Compliance & responsibility.

Throughout the entire product life cycle, innovators, sponsors, investigators, Marketing Authorization Applicants (MAAs), and Marketing Authorization Holders (MAHs) bear regulatory compliance responsibility for every vendor employed.

Therefore, the meticulous process of selecting, qualifying, and continuously evaluating vendors emerges as a crucial compliance activity spanning all GxP areas.

Information from the EMA about accountability for subcontractors in the EMA GCP Q&A (section B.2.).

Information from the EMA about delegating activities concerning the pharmacovigilance system under GVP Module II.B.3.

Information from the EMA about accountability for outsourced activities under GMP guidelines.

Information from the EU Commission about accountability for outsourced activities under GDP guidelines.

Vendor/Supplier categories.

Vendor Management and Supplier Qualification incorporate a broad range of elements within GxP compliance. The primary vendor categories can be classified as:

Raw Materials and Ingredients.
Essential for drug formulation and production including Active Pharmaceutical Ingredients (APIs), excipients, solvents, chemicals, and other raw materials.

Contract Manufacturing Organizations (CMOs).
Extending manufacturing and production services from formulation development and manufacturing clinical trial materials to large-scale commercial production activities under Good Manufacturing Practices (GMP) guidelines.

Testing and Quality Control Laboratories.
Product testing and analysis for quality, safety, efficacy to verifying compliance with regulatory standards and predefined specifications.

Packaging and Labelling.
Materials, manufacturing, and design expertise for primary packaging like blister packs, vials, bottles, and secondary packaging like cartons, labels, inserts.

Technology and Equipment.
Specialist off-the-shelf or custom machinery, equipment, and technology solutions for research, manufacturing, and quality control.

Logistics and Distribution.
Transportation, storage, and distribution of pharmaceutical products in accordance with Good Distribution Practices (GDP) guidelines.

Consultants.
Specific knowledge and expertise services.

Contract Research Organizations (CROs).
Research and development services including pre-clinical studies, clinical trial management, data analysis, and potentially regulatory submissions.

Specialised Service Providers.
Vendors providing services for clinical trials, data management, statistical analysis, market research, and providers like Aegisana for Pharmacovigilance, Compliance, and many areas.

How Aegisana can support you with Vendor Management?

Minimised risk.

Aegisana’s Compliance team is fully experienced in all aspects of Vendor Management, covering SDEAs & PVAs, contracts and other agreements, selection, due diligence, and risk assessment and scoring across GCP, GVP/VGVP, GMP and GDP. We can work with your Vendor Management Program or create one through a risk-based industry best practice approach.

Our Vendor Management services include, but are not limited to:

  • Creation and review of risk-based questionnaires based on contractual obligations.
  • Pre-qualification audits.
  • Review of qualification documentation.
  • Review of training.
  • Review of required registration.
  • Review of relevant certification.
  • References/CVs/interviews.
  • Diligence documentation maintenance.
  • Quality and Technical Agreement review and creation.
  • Periodic contract review.
  • Continuous monitoring.
  • Creation of risk management programs.
  • SDEA/PVA creation and management.
  • Vendor/supplier auditing.
  • CAPA management.
  • Site visits.

A cohesive approach.

We can create your Audit Strategy and connect Vendor Management with Audit Program Management to provide a holistic approach to risk and compliance. 

Vendor Management covers a vast array of sub-services and activities, but the aim remains the same – to ensure quality and regulatory compliance, while balancing other factors such as cost, reliability, and collaboration.

Our primary objective, as always, is to provide you with peace of mind and confidence through a meticulous and detailed service grounded in effective communication, reliability, and trust.

Through the establishment of a successful and robust strategic compliance partnership, we aim to offer comprehensive support across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.