Adopt highest GMP/GDP standards for Asian clinical trials, says Almac

Adopt highest GMP/GDP standards for Asian clinical trials, says Almac

Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.

Clinical trials across Asian countries are soaring, according to Paul O’Connor, Vice President of Global Quality at Almac, due to the need to provide new medicines for their rapidly growing populations and pharma’s desire to access local patients as both trial participants and, eventually, consumers.

However, as this market grows, he told, pharma firms and CROs face a number of challenges to ensure clinical trial materials are consistently manufactured, stored, handled, transported and distributed in order to adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

“The critical points to monitor have largely become those related to customs and duties,” he said. “GxP documents accompanying shipments may have to be translated, and some countries’ customs officers regularly open shipments without adequate understanding of the material they are handling. This can lead to difficulty with temperature-sensitive products, and even product mix-ups. ”

As for regulations and guidance, they are “well established in some countries, which is particularly helpful when clinical trial material handling is specifically described and included,” he said. “Where it is not, sponsor companies and their contracted organisations must bring their own experiences and best practices to the table.”

From country-to-country, there are also varying degrees of regulations especially relating to Investigational Medicine Products (IMPs) which require companies to use their judgment as to which standards to follow.

However, O’Connor continued, “this is not too concerning, as experienced organisations will naturally gravitate to the higher ground and follow established GMP and GDP norms.”

Furthermore, GMP hurdles can be overcome by implementing a regional manufacturing and packaging strategy, he added, which often removes the need to have multiple manufacturing licences in varying countries.

“Improved shipping components, temperature monitoring solutions and supporting technology and processes have also enabled a much more replicable, timely, and reliable distribution chain.”

“Cross-country networking”

O’Connor also spoke of “cross-country networking between regulatory bodies” as key to adhering to GMP/GDP in Asia, citing the alignment of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme (PIC/S), with documents from regulators including the US FDA, within Asian countries.

“There is further encouraging internationalisation of GMP and GDP standards in the very recent acceptance of South Korea and Japan into PIC/S membership. All of these initiatives are rapidly addressing the many issues associated with managing supplies in Asian markets.”

Finally, he said, change is being driven by globalisation. “Trial data from one territory is used to support submissions in others. That can only occur if the standards employed are above reproach.

“I’m encouraged by the progress we’re seeing, and excited to see how trials conducted within and from the region can help get critically important new drugs to market.”

Related News

Ampio shares fall as Phase III trial suffers temperature setback

Ampio shares tumble as albumin-derived trial drug suffers case of the chills

The Good Distribution Practices guidelines for active ingrdients were two years in the making. (Image: Nicholas Raymond/CC)

‘Game changer’: latest GDP rules spell full traceability for APIs

iStock/ credit Olivier Le Moal

More systems training needed to help inspectors spot data falsification say PIC/S experts

Study claims Asia is 'a new frontier for clinical development'

Parexel strikes another eClinical deal in Asia

Parexel strikes another eClinical deal in Asia

Will the Asian Clinical Trial Boom Turn to Bust?

Will the Asian Clinical Trial Boom Turn to Bust?

Catalent clinical supply plant opens its doors in China

Catalent clinical supply plant opens its doors in China

DKSH to provide clinical trial logistics services in Hong Kong

DKSH inks clinical trial logistics deal with Nordic Bioscience

BMS extends deal with DKSH in SE Asia

Bristol-Myers Squibb extends deal with DKSH in SE Asia

Related Products

See more related products