Pharma Logistics News: Q4 Highlights
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The world of Pharma Logistics didn't take its foot off the gas as the year drew to a close. The fourh quarter of 2016 saw prospects grow stronger for the launch of a debut composite refridgerated trailer in North America, new guidelines from the EMA and an investigation into a suspected pharma supply chain breach.
Growing support for debut composite reefer in North America
Wabash National Corporation obtained backing from a fourth fleet for their launch of the Cold Chain Series of refrigerated trailers constructed with molded structural composite with thermal technology – it’s design is said to be unlike any other. It is said that this bespoke technology is adds to thermal performance by 25% and is up to 20% lighter in weight. The trailer will operate within the North American Market.
Cold chain monitoring market to grow to US$6bn by 2022
The worldwide cold chain monitoring market is charted to be worth $6.23bn in 2022 up from US$3.11bn in 2015. The research from MarketsandMarkets noted that Pharma and healthcare has the largest market share of the cold chain monitoring market in 2015. Also, hardware is due to retain the majority of market share in comparison to software elements, although the later is expected to undergo a faster growth rate.
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EMA replaces Process Validation Guideline
This quarter the EMA published revised guidance to be incorporated into the pharmaceutical manufacturing process in regards to the process validation lifecycle. GMP-Publishing noted that the amendment is only deemed as minor with a focus being the definition for ‘on-line measurement’ in the glossary.
Regulator investigates suspected pharma supply chain breach
The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a large scale investigation into the diversion of prescription only medicines to the criminal market.
Following referrals from enforcement authorities in Scotland and the Republic of Ireland, MHRA became aware of a significant diversion of benzodiazepines and other hypnotics/anxiolytics.
The medicines were legitimate UK products which had been diverted from the regulated supply chain.
As part of the ongoing investigation two pharmacists based in Yorkshire have been arrested.
There is no indication that this criminality has led to medicines shortages or issues with the legitimate supply of medicines to the public.
North America set to hold dominance in Anti-Counterfeit Pharma Packaging market to 2026./
Track and trace technologies are expected to account for US$ 2,742.5 Mn by 2026, registering a substantially high CAGR of 13.1% over the forecast period to 2026. The security printing and graphics technology segment of the global anti-counterfeit pharmaceutical packaging market is expected to create incremental opportunity of US$ 537.2 Mn between 2016 and 2026.
Contract Manufacturer Quality Agreement guidance published by FDA
The FDA this quarter released their guidance on best practices with quality agreements with contract drug manufacturing in line with GMP requirements. The primary document can be accessed here.
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Resources:
1. https://logisticsmagazine.com.au/cold-chain-monitoring-market-to-be-worth-8-5-bn-by-2022/
