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Inspector Recruitment – Part Two

...accredited inspector to senior inspector, lead senior inspector, and expert inspector subject to available posts. If you are interested in building on previous management experience, several of our inspectors are...

The Responsible Person named on the WDA. Part 1: Raising the profile of the RP

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2 hands holding jigsaw pieces of the globe over the word training

...the GDP Inspectorate and Cogent Skills - The Responsible Person Gold Standard In 2013/14 an opportunity arose to develop a Responsible Person Gold Standard to join the other industry Gold...

Qualifications of suppliers and customers online: reliable or fake news?

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...2012 require licence holders and responsible persons to implement robust procedures for establishing the authority and legitimacy of a customer and supplier. Tony Orme, Expert GDP Inspector, has previously discussed...

MHRA Process Licensing: useful information

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Human head with cogs and binary code representing information

...(MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines...

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

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accurately measuring ingredients into a petri dish

...prior to despatch in the distribution area at the MIA(IMP) holder site; or where justified and controlled then immediately prior to administration to a subject or patient: application of an...

Refrigerated medicinal products, part 1: receipt and storage - some things to consider

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Industrial cold store scene

...air circulation and product should not be stored in contact with the walls or on the floor of the refrigerator. If the refrigerator is filled to capacity the effect on...

Looking for a New Challenge in 2018?

...retrieving the Product licensing or ‘Gold’ files from the archive store, then going down to our Market Towers head office in Vauxhall and photocopying information to take. There were no...

Annex 16 QP certification and batch release – frequently asked questions – part 1

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...How should the Pharmaceutical Quality System be used to support reliance on the vendor-supplied samples for importation purposes? This could be similar to a typical vendor assurance programme for the...

Good Distribution Practice - Qualification of suppliers, a helpful reminder of the 3 steps needed to assure supply chain integrity

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Front cover of the 2015 Green Guide

...for your company? Is the product being offered available in quantities or volumes that are unusually high or is the price being offered lower than the usual price? How transparent...