Estimation of Permitted Daily Exposure (PDE)
- Monitoring program of pharmacological and toxicological data for over 100 active pharmaceutical ingredients (API).
- Selection of a representative PDE value based on the pharmacological and toxicological properties of each substance and the health risk that may arise.
- Written toxicological report for every active ingredient that includes a description of the substance’s characteristics, the substance’s toxicological profile, a risk assessment, an estimation of the allowed daily usage.
- Based on the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012).
Classification of Occupational Exposure Limit (OEL) and Active Pharmaceutical Ingredients (API)
- National demands that need to be implemented in order to ensure the safety of the personnel that participated in the pharmaceutical production procedures. It is necessary to define a maximum limit (occupational exposure limit) for every active pharmaceutical ingredient (API) at work areas and to create prevention measures by taking into consideration the toxicological and pharmacological properties of each substance.
- Bibliographic research in order to review all the relevant with the active ingredient information.
- Definition of the occupational exposure limit by following the international and wide acceptable guidelines.
What is ICH Q3D?
It is the ICH Q3D guideline, which sets the limits for the impurities that may be toxic and are included in pharmaceutical products.
A list of 24 elements that are classified in 4 categories depending on the toxicity and the likeliness of incidence.
The maximum permitted dosage (PDE: Permitted Daily Exposure) for each impurity, depending on the route of administration (μg/day).
A clinical assessment of the medical devices which is aimed for the certification based on the CE, according to the Directive 93/42/EEC. The assessment is based on the protocol of a bibliographical research of all the available sources on safety, performance and compatibility of medical devices as defined by the Directive 92/42/EEC and the relevant guidelines.
The European Regulation ER 1223 / 2009 was approved in 2009 and replaced the cosmetics directive (76/768/EEC). The regulation is now mandatory, since the 11th of July of 2013. The experienced personnel can handle:
- The assessment of cosmetics safety
- The toxicological reports of ingredients
- The Safety Data Sheets for ingredients and cosmetics (SDS)
Our team is experienced in the implementation of the ISO 22716 quality system for Good Manufacturing Practices (GMP) for cosmetics making.
We can support you:
- For the GMP certification,
- For the design of a cosmetics production factory,
- For the personnel training in regard with the GMP demands
- For the risk analysis of cosmetics compatibility with other products at production facilities.
Toxicological data such as carcinogenesis, genotoxicity, reproductive toxicity, for the profile of substances, which are used either as food additives or impurities for the boost of flavor in the liquids of the electronic cigarette.