Definition: A GMP inspection is a monitoring measure that aims to verify compliance with GMP guidelines (also known as Good Manufacturing Practice guidelines) at a specific pharmaceutical company. Read the blog post by our pharmaceutical interpreters and GMP translators on this topic.

GMP guidelines are an international standard that sets out the requirements for the production of human and veterinary medicinal products as well as active ingredients, dietary supplements and cosmetics. The abbreviation GMP stands for Good Manufacturing Practice. The GMP guidelines cover all the requirements that a pharmaceutical company must fulfill: from the temperature specifications in the warehouse and production hall to the work clothing worn by employees. GMP standards are not recommendations, but rather clearly defined, strict regulations that are intended to guarantee the efficacy, quality and safety of medicinal products for end users. Compliance with these regulations is verified during GMP inspections. Qualified and specially trained GMP inspectors usually inspect the pharmaceutical manufacturer's site over the course of several days. The main areas of focus during a GMP inspection are:

• The premises (starting with the incoming goods area in the warehouse and the sampling booth)
• Production (All production lines, equipment and systems for batch production as well as filling, primary and secondary packaging lines are inspected. Only the equipment used for the production, filling and packaging of the products registered for inspection is relevant for the GMP inspectors).
• Building technology and HVAC
• Management and personnel (job descriptions, training, compliance with hygiene regulations, work clothing, etc.)
• Supplier management (responsibility delimitation agreements or contracts with all service providers, audit reports from relevant service providers)
• Quality control (qualification status of all scales and devices, their maintenance, audit reports from laboratories for microbiological analysis, storage of reference standards)
• Quality assurance (QA)
• Documentation on the pharmaceutical quality management system, all inspections, stability studies and production-related processes.

In our other blog posts, we’ll reveal many more details that the foreign GMP inspectors pay particular attention to (including specific examples of their questions).

The aim of a GMP inspection is to determine, by means of an objective, independent inspection, whether deviations and deficiencies are occurring in the areas mentioned that could impair product quality and pose a risk to patients. Should this be the case, the pharmaceutical manufacturer is ordered to rectify any discrepancies found. It is also possible to impose penalties or revoke their manufacturing authorization.

Different types of GMP inspections

Over time, several types of GMP inspections have been established. However, we mainly distinguish between three types: regular inspections, inspections for cause and repeat inspections.

A regular GMP inspection is a GMP inspection that takes place at regular intervals for the purpose of extending the validity of an already issued GMP certificate (or another document confirming compliance with the GMP guidelines).

A GMP inspection for cause, or an unplanned GMP inspection, is conducted at the request of the respective pharmaceutical company or the competent authority. These inspections take place if processes are fundamentally changed or if serious deviations occur.

A repeat GMP inspection (re-inspection) is, as the name suggests, an inspection that serves to verify the results of a previous GMP inspection. However, this does not mean that only the evidence of the completion of the CAPA plan from the previous (failed) GMP inspection is checked. Firstly, a GMP re-inspection can be carried out by completely different GMP inspectors from the same authority who have a different perspective on the production and quality control processes due to their own experience. Secondly, a previously failed GMP inspection is often a signal to the inspectors at future GMP inspections that something is not right at the manufacturing site in question and that there may be more issues. This is why a pharmaceutical company is usually inspected even more intensively during a repeat inspection than during the initial inspection.

When classifying GMP inspections, a distinction must also be made between domestic and foreign GMP inspections. During a domestic GMP inspection, the safety of the medicinal products and all production stages are inspected by the local regulatory authorities. In the case of foreign inspections, GMP inspectors from a foreign regulatory authority travel to a local pharmaceutical manufacturer to certify the activities and processes taking place there. A distinction is made between the following activities, which often take place at different locations:

• Production of APIs (active pharmaceutical ingredients)
• Production of medicinal products
• Production of intermediate products
• Production of bulk goods (non-packaged goods)
• Packaging (primary packaging)
• Secondary packaging
• Import
• Contract manufacturing
• Quality control of medicinal products (chemical-physical tests, release control, also known as batch release).

A distinction is also made between the types of products registered for GMP inspection, namely

- Sterile medicinal products
- Non-sterile medicinal products
- Biologics
- Phytotherapeutics
- Homeopathic remedies
- Medical devices

Experienced language professionals for your GMP inspection by foreign authorities

GMP-inspection.com from Nuremberg specializes in the linguistic support of foreign GMP inspections in Russian, English and German. We are most frequently commissioned when a German, Austrian or Swiss pharmaceutical manufacturer is faced with an official inspection from the following countries: USA (authority: FDA), Belarus (authority: "Centre for examinations and tests in health service") and Russia (authority: SID&GP for human medicinal products and VGNKI as authority for veterinary medicinal products). In our article "Pharmaceutical interpreters for GMP inspections by foreign authorities," you can read more about the background, important details and experiences that we have gained as a specialized service provider for professional translation and interpreting for Russian, German and English during a variety of GMP inspections. In the blog post "Professional pharmaceutical translations of 1500 pages of documents & SOPs 10 days before the remote GMP inspection," we have some tips for you on what to look out for when translating exceptionally large volumes of pharmaceutical texts shortly before the remote inspection. If you have an upcoming GMP inspection by a foreign authority and would like to call in experienced language professionals, we are always here for you!

 

Image: Raimond Klavins, unsplash.com