From 21 March 2016, pharma companies must have carried out risk assessments on all the excipients it uses to ensure they are made with an 'appropriate' level of Good Manufacturing Practice (GMP) standards.
Ewan Norton of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said at a meeting earlier this month it had been "rather concerning" that a sizeable proportion of industry delegates at the agency's last symposium in December 2015 had either not started carrying out the assessments or were unaware the requirement is coming.
He told the IPEC Europe Excipients Forum in Nice that it might be expected that some of those attending had roles which meant they did not need to be aware of the risk assessment guidelines.
Nevertheless, the high proportion saying they were unprepared - somewhere between 30 and 40 percent of the audience - suggests a real risk that from next month MHRA inspectors will find some companies are not in compliance.
The guideline is "a short document, but has a big impact," said Norton, who noted that this was why it allowed a 12-month timeframe for the risk assessments to be completed, reminding delegates that these need to be carried out "for each excipient in each product."
"This is not something that can be done quickly," he added, and could be particularly challenging for smaller companies with fewer resources.
Asked at the conference what the action of the MHRA would be in such an event, Norton said that from the implementation date - speaking personally as an inspector - he would be inclined to give companies a deficiency in the report if they were not compliant. He indicated the severity of the deficiency would depend on the type of product that was being manufactured.
IPEC Europe - which represents both suppliers and users of excipients - will shortly publish a 'how-to' document to help pharmaceutical companies establish the appropriate GMP for excipients used in their products.
The MHRA has already come across risk assessments that are poorly constructed, working the assessment backwards from the desired verdict.
"We want to see you rationally gathering information, working forwards to come to a sensible conclusion," said Norton. As in school, the advice is to "show your working," he added, as this gives a starting point for discussion and might lead to an inspector's observation of a deficiency being downgraded in seriousness.
Where gaps are found, it is imperative to carry out ongoing risk-management - continuing to monitor the situation so that issues can be fixed and monitored.
He also emphasised that a physical audit of the supplier by the drugmaker is not a requirement - and in fact should only be used where necessary to avoid over-burdening excipient manufacturers - noting that other qualifications such as third-party certifications may be used.