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GDP – Good Distribution Practice

EU Guidelines for Quality in Pharma Logistics

How can patients be sure that the medicines that arrive at their hospital, physician or pharmacist are identical to those shipped by the manufacturer? How can you guarantee that the quality of the medication you transport remains unchanged throughout the chain of supply?

Every minute of downtime is a minute of potential loss of revenue, dis-gruntled clients, supply gaps and lack of productivity. Because interruptions of business can never be prevented entirely, a solid approach to manage risks and respond to incidents and issues is critical. The international stan-dard ISO 22301 specifies requirements for organizations that wish to implement a documented Business Continuity Management System (BCM).

Each year, goods valued between eight to ten billion Euros disappear during transportation in Europe alone. The verb “disappear” covers criminal acts such
as abduction, burglary and theft. The Transported Asset Protection Association (TAPA), an association of approximately 600 international manufacturers,
logistics service providers and law enforcement organizations, was formed for the purpose of reducing such losses along the supply chain.

TISAX (Trusted Information Security Assessment Exchange) – or information security in the automotive industry - is based on essential aspects of ISEO/EIC 27001. So far, information security in the automotive industry has been strongly influenced by individual approaches - that is about to change with the introduction of this standard.

On March 12, 2018, the new version of OHSAS was published as ISO 45001: 2018. This standard now has the same structure as ISO 9001: 2015 and ISO 14001: 2015. This makes it easier to integrate into the general management system.

On 20 August, a new version of ISO 50001 was published. From now on, this standard has the same high level structure as the other ISO standards. This simplifies setting up and maintaining an integrated management system.

Since the publication of ISO 22000 in 2005, the number of organizations that choose to implement a management system for food safety has steadily increased each year. Just like ISO 9001 and ISO 14001, the new ISO 22000 was revised according to the High Level Structure and is also risk-based now. This of course implies significant changes for certified sites.

Add Water BV in Etten-Leur obtained the IFS Household and Personal Care certificate. This producer of, among other things, bath bombs aimed high and received a Higher Level certificate. Congratulations to the whole team!