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Validation of Cool/Cold Chain GDP Requirements – a common sense approach

by Jackie (née Heneghan) Peck | Apr 16, 2014 | Blog, Community Pharmacy, Pharmacy Brands, Pharmacy Suppliers, Regulation

One of the main changes seen in the recently issued European Commission Guidelines on Good Distribution Practices for medicines for human use (2013/C 343/01) is the emphasis on validating the entire supply chain to ensure that products that are temperature sensitive...

An Audit – a disruption or a useful tool?

by Jackie (née Heneghan) Peck | Apr 16, 2014 | Blog, Community Pharmacy, Pharmacy Brands, Pharmacy Suppliers, Regulation

There you are, a Team Leader/Manager, with a full workload for the day, deadlines to meet, goods to get out the door, orders to process, sales to make and you get a notification of an audit! Either internal or external, they appear to get in the way of what you need...

Risk Management – are you managing your risk?

by Jackie (née Heneghan) Peck | Apr 2, 2014 | Blog, Community Pharmacy, Pharmacy Brands, Pharmacy Suppliers, Regulation

Over the recent years we have seen a move towards risk based quality systems with risk being emphasised much more in the new Guidelines for Good Distribution Practices. But what does this mean to you and how do you put it into practice? The thing with risk management...

Drug Discovery and Therapy World Congress 2014

by Jackie (née Heneghan) Peck | Mar 20, 2014 | Behind the scenes, Blog, Pharmacy Suppliers, Regulation

Pharmacy Consulting Managing Director Jackie Peck has recently registered to attend the Drug Discovery and Therapy World Congress 2014 held in Boston, June 16-19, 2014. The organisers have put together the Press Release below for any readers of this blog who may be...

Cool Chain Supply System and Solutions 2014

by Jackie (née Heneghan) Peck | Mar 17, 2014 | Behind the scenes, Blog, Community Pharmacy, Pharmacy Brands, Pharmacy Suppliers, Regulation

Pharmacy Consulting Limited (PCL) will be presenting at The 3rd Cool Chain Supply System and Solutions 2014 (19–21 March) in Zaventem, Belgium. The symposium will address GDP inspection readiness and the lack of the global regulatory standardisation. Senior GDP and...

Wholesale Dealer’s License becomes a Wholesale Distribution Authorisation

by Jackie (née Heneghan) Peck | Mar 13, 2014 | Behind the scenes, Blog, Community Pharmacy, Pharmacy Brands, Pharmacy Suppliers, Regulation

Previously, once inspected by a Competent Authority and found to be compliant to Good Distribution Practice (GDP) you would be issued with a Wholesale Dealer’s License (WDL). This has now been replaced by a Wholesale Distribution Authorisation (Human) (WDA(H)). What’s...
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