GDP Compliance Update: Q1 2017
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Pharma Logistics IQ brings you the latest regulatory developments from across the globe regarding medicinal transportation and quality control in the pharma supply chain.
What are GDPs?
Good Distribution Practices (GDPs) are supply chain quality assurance measures that ensure products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specifications.
Q1 Updates
New rules for Russia activate:
On the 1st March, Russia’s new rules on the storage and transportation of medicines, which were published in 2016, came into effect. This activation impacts all pharma firms operating in the Russian market, they need to confirm that any contracted third parties used ( warehouses for example) are also up to standard.
New FDA GMP guidance for combination pharma products:
The US FDA published new GMP requirements guidance for combination products, following the final current good manufacturing practice rule issued back in 2013.
Lebanon released new GDP guidance.
An update was made to Lebanon’s Guidelines for Good Storage and Distribution Practices of Pharmaceutical Products. This refresh aimed to align the guidance with international standards and guidelines. More specifically regarding the conduct of Lebanese warehouses with the social responsibility approach.
HPRA publishes guide for quality wholesale distributors
Ireland’s Health Products Regulatory Authority published insight on the quality system for general sale wholesale distributors. This covered a range of subjects including the likes of inspections, change control, quality risk management, pest control programmes, temperature mapping and monitoring, waste management, transfer of medicinal products between branches and product transportation.
Saudi guideline translated into English
The Saudi Good Storage and Distribution Practice guideline which has been active since 2014, was recently translated into English. One key aspect that has received attention is the topic of the qualified person – an individual who is responsible for the implementation and maintenance of a quality system.
2016 updates:
- GDP Compliance Update: Q1 2016
- GDP Compliance Update: Q2 2016
- GDP Compliance Update: Q3 2016
- GDP Compliance Update: Q4 2016
To recap the history of GDP in pharma watch the video below:
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Resources
2. http://www.gmp-compliance.org/gmp-news/new-gdp-rules-in-russia-what-you-need-to-know
