Good Distribution Practice (GDP)

Certification of Good Distribution Practice (GDP) is a crucial element in ensuring the quality and safety of medicines within the pharmaceutical supply chain. It establishes minimum standards that distributors must meet to maintain the integrity of medical products from production to the final recipient.

GDP Ensures Compliance and Integrity of Medical Products

Compliance with GDP guarantees that pharmaceutical products in the supply chain comply with European Union (EU) regulations and are stored and transported according to appropriate standards. This prevents contamination and loss of quality during the storage and transportation of medicines.

Key Aspects of GDP Compliance

1. Safe Storage and Transport: Medicines must be stored under appropriate conditions to maintain their effectiveness and safety. Similarly, their transportation must occur under controlled conditions.

2. Avoidance of Contamination: Distributors must prevent medicines from coming into contact with other products that could contaminate them or degrade their quality.

3. Proper Handling of Medicines: There must be proper handling throughout the supply chain to ensure that products do not expire or lose their efficacy.

4. Effective Tracking and Recall: Tracking systems must be in place to swiftly detect defective products and facilitate effective recall procedures.

Scope of GDP Includes Active Pharmaceutical Ingredients

GDP covers not only finished medicinal products but also active pharmaceutical ingredients (APIs) and other substances used in drug manufacturing. This ensures comprehensive quality protection for all ingredients used in the drug production process.

Useful Links for Additional Information

• European Commission – Good Manufacturing and Distribution Practices
• EMA – Good Distribution Practice

Conclusion

GDP certification is not just a legal requirement but a crucial tool to ensure that European pharmaceutical products meet the highest standards of quality and safety. This is essential for protecting public health and fostering trust among patients and consumers.

Regulations on Good Distribution Practice (GDP) are crucial for ensuring the safety and quality of pharmaceutical products throughout the supply chain. The PR-06 certification program at COCH precisely defines the conditions necessary to obtain EU GDP certification for transport vehicles, including those designed for transporting and storing temperature-sensitive products such as medicines.

Conditions specified in the PR-06 GDP certification program include:

1. Compliance with Normative Requirements: The normative document WTP-02/2022 COCH specifies detailed requirements for Good Distribution Practice in the context of transporting sensitive products that must be carried and stored at controlled or regulated temperatures.

2. COCH Accreditation: The Central Refrigeration Center in Krakow is accredited by the Polish Centre for Accreditation (No. AC 036). This accreditation meets the requirements of PN-EN ISO/IEC 17065, confirming its competence and ability to conduct certifications in accordance with international standards.

Importance of GDP Regulations:

These regulations are essential to ensure that transported and stored pharmaceutical products are safe, effective, and maintain their integrity. This ensures that patients can trust that the medicines they receive are protected from contamination and properly handled throughout the distribution process.

Benefits of GDP Certification:

1. Product Safety: Preventing contamination and loss of quality of medicines during storage and transport.

2. Legal Compliance: Meeting European Union requirements for the distribution of pharmaceutical products.

3. Consumer Trust: Building patient trust by ensuring high standards of safety and quality.

Therefore, the PR-06 Good Distribution Practice certification program at COCH is a key element in ensuring the safety and effectiveness of transporting sensitive products, which are critical for public health and consumer protection.

Obtaining Good Distribution Practice (GDP) Certification for Transport Vehicles

GDP certification is available to all manufacturers or suppliers who meet specific organizational and technical requirements and possess appropriate tests confirming the parameters of their transport vehicles.

Who can apply for GDP certification?

1. Stable organizational and technical conditions: The company must have adequate procedures and infrastructure for producing or delivering transport vehicles that meet Good Distribution Practice requirements.

2. Production/delivery of vehicles with specified parameters: Certification is available for vehicles capable of storing and transporting temperature-sensitive products such as pharmaceuticals. The parameters of these vehicles must be confirmed by appropriate tests, including thermal insulation tests (ATP) and other required technical specifications.

3. Possession of current ATP certificate: ATP (Accord Transport Perissable) is an international certificate confirming the vehicle’s ability to transport products requiring controlled temperatures.

Procedure for obtaining GDP certification:

A company applying for GDP certification must submit an application detailing the specifics of the transport vehicle and provide documentation confirming compliance with organizational and technical requirements.

The application is evaluated for compliance with normative and technical requirements specified in normative documentation, such as WTP-02/2022 COCH.

Upon a positive evaluation of the application and completion of necessary tests and assessments, the central certifying body (such as COCH) may issue a GDP certificate for the specified transport vehicle.

Obtaining GDP certification is crucial for pharmaceutical companies and their logistics partners, ensuring that transported medicines are stored and delivered in accordance with the highest standards of safety and quality, which is critical for public health protection.