BMS can ensure medicines remain safe and effective

Building management systems (BMS) and access control solutions play an increasingly important role in ensuring that legislation is met to ensure medicines and vaccines remaining effective and not being damaged by the environment. Neil Cameron, Johnson Controls Area general manager, Building Efficiency – Africa elaborates…

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Medicines and vaccines often contain active ingredients that are sensitive to light, heat, humidity and other pollutants. If the environments in which they are manufactured, stored and distributed are not controlled carefully, their efficacy may be impacted.

Proven and approved validation systems help pharmaceutical manufacturing and distribution organisations monitor and report on key processes employed in the manufacture of medicines, the environment in which they are stored and the conditions under which they are handled and transported. Validation is as important for the management of dangerous pathogens – it’s important to control and validate the laboratory conditions in which they are kept and handled, from origination to disposal.

Intelligent BMS with their capability to measure, monitor and control environments based on preconfigured requirements, are important tools to help meet and enforce validation requirements. In South Africa, legislation requires that on receipt of goods the recording devices (temperature data loggers, refrigeration tags, freezer tags, log tags or cold chain monitoring cards) be checked and documented. Elsewhere in the world, more rigorous requirements are in place that require use of validated technologies.

In the US, for example, the Food and Drug Administration (FDA) sets out validation requirements for BMS. Today, pharmaceutical companies cannot export goods to the USA that do not comply with FDA validation requirements. To achieve this validation, organisations must make use of processes and systems that measure, capture and manage critical information related to the lifecycle of the product (manufacture, distribution, etc.) in a secure way.

A BMS for validated environments will, for example provide scalable configurations, system security, secure data management and reporting, electronic records and signatures, pre-selected and free-form annotations, time-stamped audit trails, extensive integration capabilities at all system levels, Web-based reporting (mean kinetic temperature, trend analysis and alarm analysis) and remote alarming (email, text messaging and so on).

In particular, technologies used for validation need to meet the FDA’s electronic records and signature requirements. To comply, the computer systems used to collect and analyse data must be validated to meet the FDA requirements for electronic records and signatures – i.e., these electronic signatures (authorisation) must be legally binding and the electronic records must be protected from point of creation to receipt, meaning any tampering with information must be detectable.

Using a FDA-certified BMS for validated environments, the validation process can be integrated or configured within the organisation’s building automation system. Validation can be further implemented within access control systems, an important consideration in the control of disease and handling of dangerous pathogens.

FDA-certified BMS for validated environments differ from standard BMS. Where a standard BMS will measure the temperature in an environment, a BMS for validated environments will measure and guarantee that temperature – it certifies that the temperature sensor is providing a true value, that the controller to which the sensor information is sent is responding as it should, that the information subsequently stored in the database is secure and cannot be tampered with, and that the output report containing the FDA-required information is protected.

While implementation of validation systems require effort, once in place, they provide the assurance that validation processes are being followed and that the products the organisation is taking into the market are safe and effective and of the required quality.

It’s critical that South Africa begin to make use of the technologies now becoming available to manage, monitor and validate processes related to manufacturing, storing and distributing medicines in the country. It will protect us from human error and lower risks, but also help improve processes and raise standards in the industry.


 

06 Jun 2018
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