Blog
Construction of a GDP Quality Manual
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 'how you do it'....
MHRA GDP Inspectorate – Compliance with revised Good Distribution Practice
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...
Solas agreements will reduce competition
Celescio have a new Solas agreement! They have pledged to work more closely with manufacturers and believe in a collaborative approach…
Pharmacy in the States by Eric, PHD student, USA
Industry structure Pharmacies and drug stores in the states are engaged in the retailing business of four core product categories: prescriptions, over-the-counter (OTC) medications, toiletries and cosmetics, with the most important two segments being prescriptions and...
Standard Operating Procedures – are yours fit for purpose?
During the course of our work we see many SOPs and often come across procedures that are difficult to read and do not clearly describe the procedure. A long SOP does not necessarily make it a good one! When writing an SOP it is worth thinking about what its purpose is...
Can you afford to take the risk?
Over the past few 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...
KEEP UP TO DATE – KEEP COMPLIANT!
We are living in a fast moving regulatory environment which has to address advances in products & technology, changing practices, safety issues, global markets and much more. Not keeping up with these changes can present a threat to the compliancy of your...
MHRA website move
The MHRA, along with hundreds of government websites will be moving to GOV.UK over the next few months. The new website will look very different from the current website. To help users find their way around the site, the MHRA will let us see the information on GOV.UK...
Wholesale Distribution Authorisation Applications
From the 22nd April the MHRA only accept new applications for wholesale distribution authorisations via the MHRA Process Licensing Portal – https://pclportal.mhra.gov.uk. The MHRA have issued two useful guidance documents on how to use the portal: a) Using the portal...
Bona-Fides – your new employees
This is only a quick blog item for now but we do spend a lot of time consulting to medicines wholesalers about the bona-fides they need to check and collect when qualifying new customer and new suppliers. We stress the need for such qualifying processes and of course...
Partnership Agreements – keep them relevant and up-to-date
If you're a business owner and part of a partnership it is imperative that you have an up-to-date and relevant partnership agreement. And no I'm not talking about the template your lawyer pulled out all those years ago or the copy gathering dust in the archives. Not...
CQC and care by surveillance?
In the office here, we followed a lively LinkedIn discussion talking about the use of cameras in a care home setting and whether such technology could be useful, is invasive or is wanted by the patient and their family. Many good points were raised including: 1. Well...