Quality

 

Certifications

CERTIFICATE OF GDP COMPLIANCE OF A WHOLESALE DISTRIBUTOR

The Certificate of GDP Compliance of a wholesale distributor confirms that the company adheres to regulatory standards in pharmaceutical distribution. It demonstrates the reliability and quality of the distributor's processes, ensuring the safe and effective supply of pharmaceutical products to healthcare professionals and patients.

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UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

The Union Format for a Wholesale Distribution Authorization is a standardized document issued by the EU to grant permission to pharmaceutical wholesalers. It outlines requirements and ensures regulatory compliance for safe and consistent distribution of pharmaceutical products within the EU market.

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Pharma-Europe places a strong emphasis on maintaining high-quality standards throughout all its processes. As a licensed pharmaceutical wholesaler recognized by the European Union, the company adheres to stringent quality assurance practices to ensure the safety, efficacy, and integrity of the products it handles. Here is an overview of the quality processes at Pharma-Europe:


Licensing and Regulatory Compliance: Pharma-Europe operates with a valid pharmaceutical wholesale license issued by the EU authorities, ensuring that it meets all legal and regulatory requirements for pharmaceutical distribution.

Quality Management System: The company has established a comprehensive Quality Management System (QMS) to govern all aspects of its operations. This system defines the policies, procedures, and protocols that guarantee consistent adherence to quality standards.

Product Sourcing and Supplier Selection: Pharma-Europe carefully selects reputable suppliers and manufacturers, ensuring that the products it sources are of the highest quality and comply with all applicable regulations.

Warehouse and Storage: Pharma-Europe operates its own depot, designed and maintained to meet strict requirements for storage, handling, and temperature control. The depot ensures that pharmaceutical products are stored in optimal conditions to preserve their quality and effectiveness.

Standard Operating Procedures (SOPs): The company follows meticulously crafted SOPs for each aspect of its operations, from receiving and storing products to order processing and distribution. These SOPs are regularly reviewed, updated, and strictly followed to maintain consistency and quality.

Responsible Person: Pharma-Europe appoints a "Responsible Person" to oversee the company's pharmaceutical operations. This qualified individual ensures that all processes comply with legal and quality standards related to pharmaceutical products.

Product Handling and Transportation: Pharma-Europe implements robust procedures to ensure that pharmaceutical products are handled and transported with the utmost care, minimizing the risk of damage or contamination during transit.

Product Verification and Traceability: Rigorous checks and verification procedures are in place to ensure the authenticity and traceability of all products. This ensures that the products supplied by Pharma-Europe are genuine and have a clear and documented supply chain.

Quality Audits and Inspections: Regular internal and external quality audits and inspections are conducted to assess and verify compliance with quality standards. These audits help identify areas for improvement and ensure continuous enhancement of quality processes.


By implementing these meticulous quality processes, Pharma-Europe aims to be a reliable and trusted partner, providing high-quality pharmaceutical products that meet the needs of its partners, clients, and ultimately, the patients they serve.