BE PREPARED FOR CHANGES TO PHARMACEUTICAL INDUSTRY REGULATIONS
Ecolab Life Sciences, a worldwide provider of leading products and services for the control of microbial contamination in the cleanroom environment, has sounded a warning to the pharmaceutical industry as regulations with wide ranging compliance implications begin to come into force. James Tucker, Marketing Director at Ecolab Life Sciences says: ‘For an industry which is generally risk averse, the new regulation changes will challenge current protocols like never before, meaning companies need to be proactive to avoid the consequences of non-compliance.’
The Biocidal Products Regulation (BPR) which succeeded the Biocidal Products Directive (BPD), removed the ability for country interpretation on 1 September 2013 is among the regulations which Ecolab Life Sciences has highlighted.
These changes are aimed at ensuring a high level of protection of human health and the environment. They also address the simplification and harmonization of the authorization procedures necessary to allow a company to market a biocide product for use across the EU.
To ensure compliance, the BPR’s authorized list of active substances acceptable for use in biocides requires products to be registered with the European Chemicals Agency (ECHA).
Central to these new regulations is that biocidal products should neither be made available on the market nor used unless authorized. This also applies to the purchase of raw materials with the intention of using them to biocidal effect, in-house.
The regulations apply to every manufacturer and mean that only products containing an approved active substance can be marketed legally. Failure to comply could incur fines and possible criminal proceedings for the manufacturer and end user.
Additionally, consideration should be given to market impact if the product can no longer be supplied. Ecolab Life Sciences is supporting its core range of biocides through the BPR with its regulatory department and is acting as a leader within consortia supporting the submission of actives.
Ecolab Life Sciences also has EPA Establishment Registration* as part of the registration process under different authorities. The manufacturing facility is an EPA registered facility, ensuring quality and continuity of supply for its customers.
Meanwhile, Ecolab Life Sciences is advising manufactures and importers of chemicals into the EU to review compliance with the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH requires these companies to assess the health and environmental risks associated with the use of chemicals and take the appropriate steps to manage these effectively.
Ecolab Life Sciences pre-registers every chemical it synthesizes or imports under the REACH directive, to protect customers and the environment from any potential hazards resulting from their use. Any active ingredient registered with the Biocidal Products Regulations (BPR) is part of the authorized list of active substances, acceptable for use in biocides from the BPR. The non-active ingredients used in biocides are registered under REACH.‘We continue to ensure compliance for all our substances and products and recommend other companies do the same. ‘As part of this we are continually in contact with our suppliers, especially those who manufacture our raw materials to ensure the continued availability of the substances used in our existing products and future innovations.
‘We also work with suppliers to make sure that the substances we use are covered by their REACH registration dossiers, chemical safety reports and Safety Data Sheets,’ adds Tucker.
Further regulation impacting on the pharmaceutical industry relates to the packaging and labelling of products, as part of the new European Legislation for Classification, Labelling and Packaging of chemical substances and mixtures (CLP).
This is based on the UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS), which aims to standardise the labelling of products worldwide and make their safe use more straightforward.
Although substances have needed to be classified and labelled according to CLP in the EU since late 2010, from 1 June 2015 formulations or mixtures will also need to be classified in the EU according to CLP regulations. Some classification of products will change, however Ecolab Life Sciences will not be changing any formulations because of CLP.
The update will include amended graphical representations (pictograms) of the type of hazard that a chemical product is classified as, the use of two signal words (Danger and Warning) and both hazard and precautionary statements.
‘The cleanroom disinfectant manufacturers have been working towards the 2015 deadline for some time, with no penalty being imposed for lack of compliance, ‘says Mr Tucker. ‘From this year that is all going to change and the industry needs to be ready. Put simply, if a customer purchases an unsupported or non-compliant product, they may be forced to make a change, meaning the product in use would not be validated and could result in their production lines ceasing.’
In order to fully comply with all the latest industry regulations Ecolab Life Sciences has invested more than US$1 million to date, with this expected to rise steadily over the coming years and employs a dedicated team of professionals.
Not only does that mean customers have complete peace of mind, but it keeps Ecolab Life Sciences at the forefront of delivering contamination without compromise, allowing its customers to focus on their own production.
*The EPA Establishment Registration number is 001677-GBR-001.