STERILE PRODUCTS
Sterile products
AN EXPERIENCED TEAM
TO SECURE THE SUPPLY
OF YOUR STERILE DRUG PRODUCTS
Manufacturing an injectable drug product, and more generally sterile pharmaceutical products, requires compliance with the highest safety requirements. Humanim has assembled a team of experts who are well-versed in regulatory challenges, quality, processes, and the structural evolution of companies to make the production of sterile drug product the first guarantee of patient health.
STERILE PRODUCTS ARE CLASSIFIED
AT THE HIGHEST LEVEL OF RISK ACCORDING TO QUALITY RISK MANAGEMENT
Sterile products, especially injectable drugs, must therefore meet additional criteria compared to other drugs and require perfect control of processes and operations.
The first aspect concerns sterility, i.e. the absence of contamination by viable microorganisms. The presence of these microorganisms can cause serious effects on health, including death, depending on the type of contaminant and the patient's health.
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The second criterion is non-pyrogenic, means the absence of pyrogen toxins that cause fever.
An injectable drug must also be free of particles, which can have immunological effects or trigger an undesirable inflammatory response.
Finally, any injectable drug must be isotonic, i.e. its osmotic pressure must be close to that of blood in order to avoid the destruction of blood cells. Whenever possible, it should also have a pH close to blood.
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ONCOLOGY, ENDOCRINOLOGY,
VACCINES, MONOCLONAL ANTIBODIES, HORMONES... THE FIELD OF APPLICATION
IS CONSTANTLY EVOLVING
Sterile drugs are mainly represented by injectable drugs, which are essentially administered intravenously, intra-muscularly or subcutaneously.
The type of drug administration is defined according to clinical criteria. For instance, pharmacological criteria such as when the active ingredient is destroyed by gastric conditions or is not resorbed by the digestive tract, emergency treatments with the search for an intense effect.
This is the case for hormones such as insulin, heparin, vaccine and some antibiotics such as aminoglycosides, anticancer drugs administered by infusion and biotechnology drugs.
Hormones, vaccines, anticancer drugs, but also advanced therapy drugs and other medical devices have maximum sterility constraints
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Most of the innovative therapies developed in recent years are administered as sterile products. This includes gene therapy products, cell therapy products, messenger RNA products, combination antibodies as well as the use of medical devices and combination products.
FOCUS ON QUALITY CULTURE !
HUMANIM SUPPORTS YOUR TRANSFORMATIONS BEYOND REQUIREMENTS AND STANDARDS
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Evolving regulations are driving increased use of automation to reduce the risk of contamination from human source.
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Drug product manufacturing is governed by regulations such as Good Manufacturing Practices (Europe) or current Good Manufacturing Practices (United States). At the European level, appendix to the GMP ask for specific requirements for some forms of drug products. This is the case for Annex 1, which applies to injectable medicines, with a major revision started a few years ago and planned to be implemented by 2022/23.
From a technological point of view, Annex 1 of the GMP require the operator to be as far away from the product as possible. This requires the implementation of barrier technologies such as isolators or RABS (Restricted Access Barrier Systems), automatic loading of freeze-driers or the use of robotics.
Another major aspect of this revision is the requirement to create a document called "Contamination Control Strategy" which must reflect the strategy implemented by a manufacturing site to ensure absence of any contamination into the product, based on risk analysis (Risk Management).
JOIN AN INTERNATIONAL COMMUNITY OF COMMITTED AND COOPERATIVE ACTORS
Each country has its own regulatory authorities.
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In France, the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) is responsible, among other things, for ensuring patient safety and compliance with Good Manufacturing Practices by the pharmaceutical industry.
At the European level, the EMA (European Medical Agency) coordinates the various authorities of the European Union countries.
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The different countries in the world have their own agency, like the FDA (Food and Drug Agency) in the United States.
At the global level, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (commonly known as ICH) drive efforts to achieve a better harmonization by drafting guidelines according to a scientific consensus process between regulatory agencies and industry experts working together.
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Moving towards regulatory standardization to the benefit of product and patient safety
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ANSM in France, EMA in Europe, FDA in the United States... regulations on sterile products are gradually coming together as part of the mutual recognition process.
In addition, for common responses and shared best practices, the healthcare industries are grouping together in associations. Examples include A3P, a French association with a European influence, and American associations such as the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE).
These associations take the opportunity to collaborate and provide a common positioning to new regulations, as currently for the revision of Annex 1.