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).

PIC/S

Currently, 56 regulatory authorities from all over the world are members of PIC/S. Training GMP inspectors is an important part of the work that PIC/S does.

PIC/S is an acronym for Pharmaceutical Inspection Co-operation Scheme. PIC/S is an international association of GMP regulatory authorities. PIC/S is intended to help improve cooperation between regulatory authorities (German translation: Zulassungsbehörden) and the pharmaceutical industry in the area of Good Manufacturing Practice (translation into German: Gute Herstellungspraxis). Currently, 56 regulatory authorities from all over the world are members of PIC/S. Training GMP inspectors is an important part of the work of PIC/S.

The most important goals and functions of PIC/S include:

  • Harmonizing standards: PIC/S supports the development and harmonization of standards and legal requirements for the inspection of pharmaceutical companies and the marketing authorization of drugs.
  • Exchange of information: The organization ensures that pharmaceutical regulatory authorities share information and expertise in order to improve their ability to inspect and monitor drug manufacture.
  • Cooperation: PIC/S promotes cooperation (German: Zusammenarbeit) between the regulatory authorities of different countries in the field of drug inspection, which helps to streamline their work by avoiding unnecessary redundancies, and save resources.
  • Training and further education: The organization supports the education and training of inspectors and other professionals working in the field of drug control.
  • Developing guidelines: PIC/S develops guidelines and recommendations in order to facilitate compliance with the standards and requirements for pharmaceutical inspections.

Members of PIC/S can be national and regional regulatory authorities that inspect pharmaceutical production facilities and oversee the pharmaceutical industry. This organization enables the member countries to work together to improve the quality and safety of pharmaceutical products and ensure that they meet international standards.

You can book qualified pharmaceutical interpreters for your foreign GMP inspection at GMP-inspection.com. We are more than happy to support you on site or remotely and ensure that you can concentrate on the content of your inspection instead of language barriers. We also offer the following services: Consultancy in the run-up to GMP inspections, representation of international pharmaceutical companies and distribution of their products in Germany. Write us an email!

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