GMP/GDP certificate

Our GMP and GDP certificates attest to our high level of safety and quality along the entire value chain.

We guarantee the highest level of safety for your medicines.

PS Pharma Service GmbH has an established quality assurance system that complies with all regulations (GMP and GDP) and is monitored by the regulatory authorities.
Quality and safety
One of the most important criteria when handling narcotics is that companies can be one hundred percent sure that their drugs are produced, stored and transported absolutely safely.

In terms of consumer protection, every pharmaceutical service provider that handles drugs and medical devices must generally follow a variety of different quality guidelines. These guidelines are prescribed by law and are monitored by the authorities.

As a specialty service provider of narcotics and medical cannabis, we have validated all processes and machinery to ensure the highest level of quality and safety. Only recently, we were once again awarded a GMP and GDP certificate by the Düsseldorf district government in accordance with the strict guidelines of the EU Commission.

Our certified quality management system fulfills the following requirements according to § 13 AMG, GMP and GDP:
  • certified quality management system
  • Expert and appropriately qualified employees
  • qualified facilities for preparation, packaging, labeling and label coding
  • Appropriate equipment and utilities
  • Approved materials, containers, and labels
  • Approved process descriptions and instructions
  • Suitable and adequately secured storage facilities
  • certified transport conditions
GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

What does GMP mean?

The abbreviation GMP stands for Good Manufacturing Practice. The principles and guidelines of Good Manufacturing Practice for medicinal products for human use describe in detail the measures that companies must take during production, storage and packaging to ensure the highest product quality.

In addition, proof of a complete documentation system, competent and appropriately qualified personnel and a regulated returns policy are among the basic requirements for obtaining a GMP certificate.
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GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS

What is GDP?

Good Distribution Practice refers to all measures that ensure that the quality and integrity of pharmaceuticals is maintained throughout the supply chain. For example, to obtain a GDP certificate, companies must be able to demonstrate that temperature and climate conditions are within an optimal range throughout transportation.

In accordance with the requirements of the Principles of Good Distribution Practice for Active Pharmaceutical Ingredients for Human Use, all premises, processes and, above all, the specification and verification documentation are also regularly inspected by the responsible supervisory authority.

Contact

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Semdor Pharma Group
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