Consultancy Archives - Page 8 of 8

Not physically handling medicinal products? Wholesale Distribution or Brokering?

by Jackie (née Heneghan) Peck | Nov 17, 2014 | Blog, Quality Systems, Transportation, WDA(H), WDA(H)

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...

Urgent! Medicines Distribution in the Maritime Sector

by Jackie (née Heneghan) Peck | Nov 10, 2014 | Blog, MHRA, Quality Systems, Regulation, Training, WDA(H), WDA(H)

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,...

GDP/RP Refresher Courses

by Jackie (née Heneghan) Peck | Oct 28, 2014 | Blog, Consultancy, Good Distribution Practice - GDP, RP, Training

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...

Are you compliant with the revised Good Distribution Practice?

by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Consultancy, GDP/RP, Good Distribution Practice - GDP, Training

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

by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Bona Fides, EudraGMDP, Good Distribution Practice - GDP, Pharmacy Suppliers, WDA(H)

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...

Transportation – how long can you hold products before a WDA is required?

by Jackie (née Heneghan) Peck | Oct 3, 2014 | Blog, Good Distribution Practice - GDP, Transportation, WDA(H)

Since the application of the Falsified Medicines Directive in January, 2013 there is a new requirement that anyone involved in the export or holding of medicinal products intended for export, for wholesale distribution, now require a Wholesale Distribution...

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Not physically handling medicinal products? Wholesale Distribution or Brokering?

Urgent! Medicines Distribution in the Maritime Sector

GDP/RP Refresher Courses

Are you compliant with the revised Good Distribution Practice?

Supplier Qualification and GDP Compliance

Transportation – how long can you hold products before a WDA is required?

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