News Feature | April 28, 2014

Generics Quality Brought To The Forefront In UK

By Lori Clapper

The British Generic Manufacturers Association (BGMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are joining forces to combat quality challenges in the UK’s generic pharmaceutical manufacturing industry.

Current regulations demand that generics meet the same standards of quality, safety, and efficacy — as well as deliver equal medical benefits as the brand name counterparts — before landing in patients’ hands.

In an effort to maintain and improve quality systems, the BGMA and MHRA have formed a quality forum.  The strategy behind the collaboration is to intentionally foster open discussion on key quality issues between generic medicines companies, manufacturing, quality control service providers, as well as the MHRA.

“Quality is a key component in ensuring that patients get their medicines in a timely and affordable manner,” BGMA’s Technical Director Paul Fleming explained. “Our forum will provide a vital conduit between industry and the regulator on a topic which is critically important to the successful operation of the generic medicines marketplace in the UK, Europe, and internationally.”

He added that regulatory requirements and the supply chain are rapidly becoming more complex.  Because of this, it’s vital that the generic pharma community share information quickly and easily to increase mutual understanding of the quality issues at hand.

The MHRA backs the initiative to solidify the organizations’ stance on quality in generic pharmaceutical manufacturing processes. 

“We are always keen to share knowledge and expertise so that companies can fully understand the regulatory environment in which they operate,” Mark Birse, group manager GMDP inspections, MHRA said. “This is key to ensuring that safe and high quality generic medicines are being made and distributed, and provides the trust needed by patients and healthcare professionals to use them.’

Birse also believes that direct dialogue with industry experts will provide valuable feedback and insights from their perspective.

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