Blog
RP & GDP Training for WDA(H)
RP - Responsible Person relating to MHRA GDP - Good Distribution Practice - the guidelines by which medicine wholesalers must adhere to WDA(H) - Wholesale Distribution Authorisation for Human Use - previously Wholesale Dealer's License Should you possess a WDL or WDA...
Out of Specification (OOS) Test Results
What are Out of Specification results (OOS)? It seems to be clear enough in the name but I thought I better check it out. One definition is: All test results which fall outside the specifications or acceptance criteria established in drug applications, drug master...
Wholesale Dealer or Distributor? Wholesale Licence or Authorisation?
Which one do you have? I know we now have to have a wholesale distribution authorisation (WDA ) to wholesale medicines but I still find myself saying wholesale dealers licence and wholesale dealers authorisation. Why the change? We have to come into line with the rest...
Today’s thought – small business
So here's my rant for the day ... it reflects just some of the difficulties of being a small business owner! It is a crazy old world in the same month I have had a letter form David Cameron, telling me he is saving me £2000 in NI contributions this year and then...
Quality Agreements- Technical Agreements- Good ones are invaluable!
TAs - when do we need them in place and who with and what should be in them? PCL have been reviewing a few TAs over the last few weeks and we have put a few tips and hints together. If you only follow GDP or GMP; the principals are the same. If you are a manufacturer...
The current state of Pfizer
Pfizer’s bid for AstraZeneca scrutinised - should it be only the shareholders who decide? AstraZeneca employs over six thousand people in the UK. Pfizer has made nine promises in a letter to David Cameron which are said to reflect Pfizer’s commitment to the UK. The...
Responsible Person for Wholesaling – MHRA
If you're applying for a new Wholesale Distribution Authorisation - WDA(H) - you will need to have a Responsible Person or RP registered to the Authorisation. This person needs to be approved and registered by the MHRA. As a new wholesaler you can choose to nominate...
What constitutes a “bona fide”?
Adjective: Genuine; real. Adverb: Without intention to deceive. Noun: Good faith; absence of fraud It is a crazy world, in the last year I have been asked during training ….what is a bona fides? How do you check a suppliers bona fides? We go into great detail...
Providing evidence to NHS England for Internet Pharmacy
So you've decide to apply to open an internet pharmacy and you've read the application form and it seems simple enough. I mean people send you prescriptions in the mail or via ETP2, you dispense and you send it out via mail or courier. It's not a hard prospect to...
IT – Cloud solutions for storage and management of clinical data, Quality Systems and SOPs
What do you do with your old SOPs? Do you have space to store them in your office? Do you archive them? Do you have staff who work from home or in other countries? Do you save them digitally or in paper form? I am old enough to remember “Punch Cards “and “Microfiche”...
“Special Measures “- The NHS Trust Development Authority (TDA) – Monitor-CQC
What are special measures and how do NHS TDA Monitor and CQC work together? What will happen when NHS TDA and Monitor place a trust in “Special measures”? CQC, through their chief inspector may recommend that a Trust is placed in special measures if they have evidence...
2014 GPhC Inspections – are you prepared?
It seems 2014 will be the year of GPhC inspections for many pharmacies across the UK. Many of you may have impending inspections with many more to follow. We've had a number of pharmacists contact us recently about the inspection process, what to expect and what...