Generics makers will be able to use the three-times-a-year forum to pool information with the UK regulator about quality inspections, the ingredients supply chain, and the effects of recent legislation, said Paul Fleming, BGMA Technical Director.
The arrival of the Falsified Medicines Directive in Europe in January 2013 increased regulatory requirements for generics makers, he said, and one of the first items on the forum’s agenda would focus on understanding and implementing the new legislation.
The 2013 rules mean active pharmaceutical ingredients (APIs) imported into the European Union (EU) require a “written confirmation” of quality from their origin country, with the exception of a handful of nations.
Many drug manufacturers worried the extra red tape would cause API shortages. Although this generally did not happen, the law effectively globalised the supply chain arrangements of the pharmaceutical industry, meaning “generics companies need to take another look at how they organise their quality to reflect a globalised set-up,” said Fleming.
BGMA already runs a similar forum for regulatory affairs, but “when we talked to our members about the type of issues they’re facing, we found the time was right to do something specifically in the area of manufacturing,” continued the Association’s director.
Qualified Persons: audits and inspections
Changes to the European regulatory framework with the new directive have brought more emphasis on how the Qualified Person (QP) exercises their responsibilities, Fleming told us. In the EU, a QP is the person within a company responsible for certifying batches of medicinal products before they can be released.
The forum’s early sessions will address how internal auditing programmes led by QPs can be integrated with external MHRA inspections, so the organisations can pool their knowledge.
“That’s something the MHRA brought up and they’re interested in how those two parallel activities can be more closely integrated,” said Fleming. BGMA hoped that sharing the information could be useful for both organisations, specifically when it comes to the performance of manufacturing sites, he continued.
Companies generate audit reports for their own factories, or those where their work is being outsourced more frequently than the MHRA’s periodic inspections, which occur every two to three years for a limited number of days.
“Bringing the information from both together will help us get a better picture of a plant’s compliance status,” said Fleming, providing “snapshots” of how the sites perform and change over time, “giving a continuous picture of quality.” He expressed hope companies would draw “early warnings” from the data about obstacles to manufacturing and quality, and work toward “continuous improvement.”
The organisers plan for the forum to meet three times a year, with the first meeting on June 4 2014, followed by one on November 12 and another early next year. In each case the agenda will be developed by MHRA and by the industry – both existing Association members (about 25 generics businesses), and outsourcing companies providing manufacturing and quality control services, affiliated with the BGMA for the first time through an associate membership programme. Senior members of the MHRA inspectorate will represent the regulator.