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GDP Audits

A GDP or Good Distribution Practice audit is essential to ensure compliance with regulatory standards in the distribution of pharmaceutical products. Each company as part of this supply chain is required to undergo regular monitoring or assessment. Holders of manufacturing authorizations are not only required to prove manufacture of the active ingredient in accordance with GMP, but also distribution of the products in line with Good Distribution Practice (GDP). It is therefore necessary to perform GDP audits on a regular basis at logistic service providers, re-packagers, wholesalers and warehousing companies. blue inspection performs comprehensive GDP audits in the areas of storage, transport and wholesale distribution.

Key Components of a GDP Audit

A GDP-audit-checklist is a practical tool during the audit for verifying the implementation of GDP. The key components of a GDP audit typically include:

  1. Quality Management System: Evaluation of procedures in the implemented quality management system to comply with GDP requirements.
  2. Personnel: Assessment of the qualifications, training, and responsibilities of the staff involved in the distribution of pharmaceuticals. 
  3. Facilities and Equipment: Inspection of the storage and transportation conditions, including the cleanliness, temperature control, and security measures in place.
  4. Documentation Review: Verification of the accuracy and completeness of records related to the procurement, storage, and transportation of pharmaceutical products.
  5. Operations: Examination of procedures for the handling, storage, and transportation of pharmaceuticals.  To ensure procedures are in place to avoid contaminations, mix-ups or errors.
  6. Temperature Control: Maintaining strict temperature conditions during storage and transportation of temperature-sensitive products.
  7. Complaints and Recalls: Review of complaint management and product recall procedures.
  8. Supplier qualification: Review of agreements and assessments of suppliers to ensure they meet established standards.
  9. Risk Management: Analysis of the risk assessment and mitigation strategies in place for identifying, evaluating, and mitigating risks throughout the supply chain.
  10. Change Control: Managing changes in the distribution process effectively without compromising product quality or compliance.

Guidelines for GDP Audits

Good Distribution Practice (GDP) audits assess compliance with regulatory requirements and adherence to industry standards within the supply chain of medicines. Pharmaceutical companies face the most stringent requirements in the handling, storage and transportation of medicines in order to protect patient safety. The following are the internationally recognized guidelines for GDP audits:

  • EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use
  • EU Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use.
  • The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients

Benefits of a GDP Audit

Companies engaged in pharmaceutical distribution must prioritize GDP audits to maintain the trust of healthcare providers, regulatory authorities, and ultimately, the patients who depend on the quality and safety of the products. Supply-chain security ensures that the active pharmaceutical ingredients, excipients and finished medicinal products reach further processing or end-customers in their unchanged forms. A well-executed GDP (Good Distribution Practice) audit offers numerous benefits to companies within the supply chain; it verifies compliance with legal and regulatory standards, helping to ensure that proper storage and transportation conditions are met. The GDP audit can identify areas for operational improvement, leading to enhanced efficiency and reduced costs. Additionally, it can provide valuable insights into the supply chain, facilitating better risk management and contingency planning. Ultimately, a GDP audit ensures that the quality level established in manufacturing by applying GMP guidelines is maintained during distribution as well. Contact us at blue inspection for your GDP audit requirements!
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