The importance of a toxicology study in the conceptual phase

Typically, cGMP compliance is not given the same weight in the pharmaceutical industry as the risk caused by the drugs expected to be manufactured at the facility.

The regulations governing this sector require compliance with standards associated with GMPs and the pharmaceutical form to be manufactured (oral solids, liquids, semisolids, sterile…). In addition, we must study and define a whole series of issues associated with GMP compliance such as the flows of materials and people, classification of areas, qualification of facilities and equipment… Pharmaceutical laboratories have to go through a regulatory process in order to approve the installation, being periodically inspected to see the degree of GMP compliance.

On the contrary, when establishing in a pharmaceutical project what is the toxicological risk of the active principles that are expected to be handled in the plant, we find a great lack of definition, being a key requirement in the first phases of the design of a pharmaceutical facility.

The causes of this ignorance can be several:

  • The type of products to be manufactured in the plant in the future is unknown. In the case of CMOs, it is critical to leave the plant prepared to cover as wide a range of products as possible.
  • The applicable regulations are unknown. In Spain we have some NTP (1104 and 1105) from the National Institute for Safety, Health and Well-being at Work (INSSBT) which are basic tools in order to define the technical and organizational measures to comply with based on the risk of the products. .
  • Unlike the GMPs, there is no inspection by a public body that has to periodically certify that the appropriate measures are in place to protect workers.
  • The safety and hygiene department does not have the same weight as other departments. This department is normally relegated to an almost testimonial weight in many cases.

It’s important to put attention on:

  • The number of products with high toxicological potency is increasing and they are especially attractive for third-party manufacturing.
  • A project does not become substantially more expensive if the type of products that are expected to be manufactured in the future are taken into account from the outset. You can define changing rooms, access to materials, locks, HVAC partitioning, access control… and leave the plant ready to manufacture products with a determined toxicological risk. What makes it more expensive and in many cases very difficult to carry out is, once the plant is finished, adapting to comply with the technical measures associated with higher-risk products (which is what happens in many cases).
  • The technical measures have to be perfectly defined for the type of products that are expected to be manufactured and there are a series of management responsibilities as indicated in Law 31/1995, of November 8, on Occupational Risk Prevention. Article 42. Responsibilities and their compatibility.

Failure by employers to comply with their obligations in terms of occupational risk prevention will give rise to administrative responsibilities, as well as, where appropriate, criminal and civil responsibilities for damages that may arise from such non-compliance.

In short, in the face of such an important pharmaceutical project it is to have a facility that complies with GMP requirements, as well as the technical measures associated with the toxicological risk of the products that are expected to be manufactured in the future. For this reason, a toxicology study in the definition phase may become essential to avoid risks that translate into enormous problems in the future.

If you are interested in learning more about product toxicology and how we can help you, contact us: