Protak Scientific has announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to support the company in the formation of a focus group to discuss the use of enzyme indicators (EIs) in the UK.
The MHRA has seen the potential of the use of enzymatic indicators to measure decontamination validation and has offered to support the industry and provide a regulator's perspective and assistance to those that are interested.
Protak Scientific is the exclusive worldwide supplier of enzymatic indicators for decontamination validation. The company works with major pharmaceutical companies and regulatory bodies to improve efficacy, save money and, ultimately, save lives.
According to Protak, one of the misconceptions from interested parties is that regulators will not embrace new technology or advances in the scientific understanding of process validation. "Put simply this is not the case. Rapid microbial methods are advancing the science of validation and regulatory are ready to be supportive of such technologies and would be users," the company said in a statement.
As a first step the MHRA have offered to meet with pharmaceutical manufacturers and interested parties at the MHRA offices in London to discuss and advise on regulatory perspective.
The group will discuss issues and opportunities with the UK decontamination validation industry to include the following:
- Discussion between innovators and regulators to help allay fears that end users may have of the MHRA’s approach to new validation technologies and techniques
- Creation of focus groups such as this will aid the industry to navigate the regulatory processes, allowing for the rapid progression and installation of the technology across the industry
- Encourage movement from the former use of biological indicators, to more current rapid microbial methods technologies such as enzymatic indicators
- Learn more about the quantitative measure of decontamination efficacy enzymatic indicators to produce comparisons and correlations to Geobacillus Stearothermophilus
- Appreciate the revolutionary nature of the enzymatic indicator and its ability to allow total cycle mapping to be achieved in minutes.
Rapid microbial methods are advancing the science of validation and regulation, and the group is ready to support such technologies and would-be users.