The Importance of Temperature Within the Pharmaceutical Industry

Regulations

The World Health Organisation (WHO) develops international norms and standards to regulate health products and to eliminate substandard medicines, but must pharmaceutical manufacturers comply to the WHO norms?

The International Council for Harmonisation for Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and the pharmaceutical companies and develop ICH guidelines that are applied by the regulatory authorities. A regulatory authority is a public or government agency responsible that creates rules and regulations for a specific area of application, each country will have their own regulatory authority and as of such, their own rules and regulations.

The best-known authorities are the US Food and Drug Administration (FDA) and the EudraLex – EU Legislation regulating who can manufacture, stock and distribute medicinal products. Medicinal products may be manufactured in one country but are imported into another: these products are subjected to the receiving country’s authority. So, it makes sense that all regulatory authorities are aligned.

However, as the official regulations leave room for interpretation, organisations have been created to ensure that all regulated companies understand and comply to the regulations:

• The International Society for Pharmaceutical Engineering (ISPE),
• The US Pharmacopeia (USP),
• The World Health Organisation (WHO).

The International Organisation for Standardization (ISO) is an independent, international organisation that develops international standards. Standards are voluntary and not mandatory, however, regulatory authorities many use standards to support technical regulations.

So, no, pharmaceutical manufacturers do not have to comply to the WHO norms and standards to deal with pharmaceutical products. The regulated company must comply with the regulations defined by the local regulatory authority and can then use the WHO norms and standards to help comply with the regulations.

Temperature Defines Product Quality

When certain products are exposed to incorrect temperatures the product quality is no longer guaranteed. In the pharmaceutical, cosmeceutical and the food industry, this is even more important as consumers lives can be put at risk due to the temperature effects on the products/ingredients such as decomposition, diminished effects/taste and spoilage.

In the pharmaceutical industry regulations have been put in place to protect the patients and to deliver quality-assured, safe and effective products. The temperature range, along with other parameters, to ensure product quality is defined during the product risk assessment.

What Are Pharmaceutical Products:

Drugs, medicines, vaccines active pharmaceutical ingredients (API), human samples, bio-pharmaceuticals, medical devices…

Applications

Here is an overview of the applications where temperature monitoring is crucial:

• Cryogenic monitoring.
• Ultra-low temperatures monitoring (including with dry ice).
• Fridge/freezer monitoring.
• Stability testing.
• Incubators monitoring.
• Storage monitoring.
• Warehouse monitoring.
• Distribution centre monitoring
• Cleanroom monitoring.
• Transport monitoring (trucks, airplanes, containers, trains…)
• Healthcare sales point monitoring (pharmacies, vets, dentists, hospitals…)
• Blood bank monitoring
• Tissue bank monitoring
• Biobank monitoring
• Calibration laboratory monitoring