Good Distribution Practice - GDP Archives - Page 9 of 9

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...

Construction of a GDP Quality Manual

by Jackie (née Heneghan) Peck | Aug 13, 2014 | Blog, Good Distribution Practice - GDP, Quality Systems

During the course of our work we often find that there is little understanding of what a quality manual is and what should be in it. Simply, the quality manual forms the basis for your quality system and is the ‘what you do’, whereas the SOPs are the...

MHRA GDP Inspectorate – Compliance with revised Good Distribution Practice

by Jackie (née Heneghan) Peck | Aug 13, 2014 | Blog, Good Distribution Practice - GDP, MHRA

On the 12th August, 2014, the MHRA GDP Inspectorate issued an e-mail to all Wholesale Distributors regarding their concerns that they are continuing to record a number of major deficiencies where the revised EU Guidelines on Good Distribution Practice have not been...

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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?

Construction of a GDP Quality Manual

MHRA GDP Inspectorate – Compliance with revised Good Distribution Practice

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