Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Contract laboratory

Contract laboratories can take on a wide range of tasks, from pharmaceutical analysis to carrying out complex research work and developing new products.

A contract laboratory is a specialized facility that provides scientific and analytical services on a contract basis to other organizations, primarily in the pharmaceutical, biotechnology, chemical, food and environmental industries. These laboratories can take on a wide range of tasks, from pharmaceutical analysis (German translation: pharmazeutische Analytik) to carrying out complex research work and developing new products.

The most important functions and services of contract laboratories (German: Auftragslabore) include:

  • Analysis: Carrying out chemical, microbiological, physical and biological analyses to test of raw materials as well as intermediate and end products.
  • Development and validation of methods: Development of new analytical methods and their validation to ensure the accuracy and reproducibility of results.
  • Stability studies: Determining the shelf life of products and studying the effects of different storage conditions (translation into German: Lagerungsbedingungen) on product quality.
  • Consulting services: Expert advice on quality, safety, compliance with regulations and optimization of production processes.

Advantages of using the services of contract laboratories:

  • Specialization and expertise: Contract laboratories have a high degree of specialization and boast modern equipment for carrying out complex analysis tasks.
  • Saving resources: By working with contract laboratories, companies can reduce equipment and staff costs.
  • Compliance with legal regulations: Contract laboratories ensure that the analyses and studies are carried out in accordance with the applicable regulatory standards and the guidelines of Good Manufacturing Practice (GMP).
  • Flexibility and scalability: Contract laboratories can quickly upscale research projects according to customer needs so the customer does not have to invest in expanding their own laboratory facilities.

Contract laboratories play a key role in ensuring product quality and safety, accelerating research and development, and helping companies comply with international guidelines and regulatory requirements.

The pharmaceutical interpreters and GMP translators at GMP-inspection.com in Nuremberg are happy to assist your pharmaceutical company with GMP inspections by foreign regulatory authorities. We can also provide specialist pharmaceutical translations for you if a foreign authority requires SOPs or other documents to be translated.

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