Blog
Bona Fides – Do You Know What to Look for When Approving a Supplier or Customer for the Distribution of Medicines?
Is a copy of a WDA(H) enough evidence to approve a supplier? NO! Evidence of a WDA(H) is just one of the steps required for supplier approval. If obtaining the product direct from manufacturer or from another wholesaler the authorisation is no longer enough. The...
Falsified Medicines and the Introduction of Safety Features for Wholesale Distribution Authorisation Holders
Welcome to the new unique identifier that will come into implementation during 2015. Giving a three year count-down to all companies involved with the distribution of medicines. The composition, format and carrier of the unique identifier will be harmonised across the...
Data Integrity within your Quality System and Wholesale Business
DATA INTEGRITY - is Mickey Mouse filling in your documents? What is data integrity? The extent to which all data are complete, consistent and accurate throughout the data lifecycle. From its generation and recording to use, retention, archiving, retrieval and its...
Not physically handling medicinal products? Wholesale Distribution or Brokering?
We often hear people stating that they don't actually handle medicinal products, therefore they do not need a WDA - this is not strictly a correct statement. Even if you do not, physically, handle medicines, you will need to either register as a broker with the MHRA...
Opening A Distance Selling Pharmacy Training
Are you thinking of opening a Distance Selling Pharmacy? We are conducting a training course for anyone considering opening a Distance Selling Pharmacy. The course will give an overview of the requirements of opening an internet pharmacy and provide a...
Urgent! Medicines Distribution in the Maritime Sector
The MHRA has today, 10th November 2014, published their guidance on their expectations for the supply of medicines to the maritime sector. http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON473634 Any UK marine company procuring, storing,...
Inspection Non-Conformities?
Have you recently had a GDP inspection by the MHRA where non-conformities have been identified? Are the non-conformities relating to your compliance to the new guidelines? PCL offer a range of services to help you to comply and retain your WDA(H). From assisting with...
GDP/RP Refresher Courses
If you have, recently, tried to register for the 2014 MHRA GDP symposium, you will have found it to be fully booked. If you have missed your space this year, why not register for one of PCL's RP update courses? Our GDP/RP courses are held twice a month in the South of...
BD buys CareFusion for $12.2 billion
Medical equipment supplier Becton Dickinson & Co has agreed to buy CareFusion Corp , a maker of infusion pumps and other medical devices, for $12.2 billion in cash and stock, marking the latest multibillion-dollar healthcare sector deal. Cost-related healthcare...
Getting to the root of the problem!
Here's the scenario: A customer has phoned to say that they have received an incorrect product. A quick investigation has been done and it has been established that the wrong product was despatched resulting in the customer being sent the correct product. Ok, so this...
Are you compliant with the revised Good Distribution Practice?
On the 12th August, 2014 the MHRA issued an e-mail stating their concerns that a significant number of major deficiencies are being identified where wholesalers have not read, understood or implemented the revised EU Guidelines on Good Distribution Practice. The...
Supplier Qualification and GDP Compliance
As a Wholesale Distributor you must now verify that your suppliers are in possession of a valid authorisation AND that they comply with the principals and guidelines of good distribution practices. This will need to be described in your Supplier Qualification SOP and...