Outsourcing certain distribution activities for medical devices and pharmaceuticals can help organizations operate efficiently, but it also raises compliance challenges. Under Good Distribution Practice (GDP) standards—such as WHO GDP, EU GDP, PIC/S GDP, and local regulations—both the contracting organization and the outsourced provider have specific responsibilities. Understanding these roles is essential to maintain product integrity and meet legal requirements. This article explains what each party must do to ensure full GDP compliance.
Organizations and Outsourced Service Providers Do to Comply with GDP Requirements?
When an organization is required to implement Good Distribution Practice (GDP) regulations for medical devices and pharmaceuticals, and certain distribution activities are outsourced, a critical question arises:
What responsibilities do the contracting organization and the outsourced service provider have to ensure compliance with GDP?
The answer lies in GDP-related standards such as WHO GDP, EU GDP, PIC/S GDP, and local regulations issued by the Ministry of Public Health. These standards clearly define the responsibilities of both parties:
Responsibilities of the Contracting Organization
Establish a Written Agreement: A formal contract must clearly outline the roles and responsibilities of each party, including key details such as the scope of activities, product requirements, and applicable regulations.
Assess the Capability of the Service Provider: This assessment may include an audit before signing the contract and periodic reviews after activities commence. Alternatively, a self-assessment questionnaire can be used. The evaluation must cover GDP requirements relevant to the outsourced activities, and the frequency of audits should be based on risk assessment.
Responsibilities of the Outsourced Service Provider
- Perform all assigned activities in full compliance with GDP requirements.
- Do not subcontract any tasks to third parties unless the third party has been evaluated, audited, and approved by the contracting organization beforehand.
Summary
Any GDP-related activity carried out by an outsourced provider must be properly defined, agreed upon, and controlled to prevent misunderstandings that could compromise product integrity and credibility.
About SGS
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