Blog
Audit or raise a CAPA?
What would you do, raise a CAPA or conduct an Audit ? If your Contract Warehouse has a couple of deviations from storage GDP requirements in quick sucession, and you have not audited them in a whil,e would you raise a CAPA or audit them? Pharmacy Consulting was asked...
100 hour Contracts for Sale?
** April 2014 UPDATE ** So whilst Pharmacy Consulting remains available to assist in assessing 100 hour contracts available on the marketplace, the number of available contracts are diminishing. As time goes on and these previously exempt contracts becoming rarer,...
Manufacturers, Importers and Distributers are targeted by The Falsified Medicines Directive 2011/62/EU
Do you “Manufacture, Import or Distribute”, “Active Substances” currently in the UK? You should have received an mail from the MHRA regarding Falsified Medicines Directive 2011/62/EU. Registration with the MHRA is compulsory and has to be completed before the 2nd of...
“Retail” and “Wholesale” transactions must be separate!
The MHRA expects pharmacies with WDLs to keep their pharmacy stock and their wholesale stock completely separate and that the “Retail “and “Wholesale” transactions are fully documented and separate. If the pharmacy chooses to export any medicines in short supply in...
Is your Pharmacy wholesale dealing without a WDL?
If your pharmacy is wholesale dealing medicines for human use you may be potentially contributing to UK shortages and be in breach of both supply chain obligations and GPhC standards of conduct. http://www.pharmacyregulation.org/ The Department of Health has issued...
Pharmaceutical Needs Assessment identified a need and still no contract was granted.
Pharmacy Consulting recently had a client who had had his 100 Contract Application put on hold because the PCT wanted to tender an out of hour’s contract to all contractors in the area. My client took the PCT to court and won his case. Pharmacy Consulting then...
Contracts and TAs are they legal?
When setting out to prepare a contract with a customer or supplier or a Contract RP etc., it is useful to consider and include the following points. It is always sensible to have a written contract to ensure it is legally binding and the contract should contain an...
GP and Pharmacist Colaboration
Collaborative working will help your pharmacy survive the rocky road ahead and is the key to better patient outcomes and effective medicine management. To ensure a relationship will blossom it requires a breakdown in silo working, good communication and indeed...
Tutela Temperature Monitoring?
Who do you use currently to monitor your warehouse and your goods in transit? Is the system validated?Have you validated them yourself?Have you validated your logistics supplier? Pharmacy consulting has been asked by two inspectors in the past couple of months to...
Validation of your Logistics Supply Chain?
Do you validate your logistics supply chain currently? If you buy from, or supply to, countries where temperatures are extreme how do you know that your products have been stored and transported within the recomended temperatures required by GDP and the MA for the...
Are you a Broker? Are you registered yet ?
A broker does not wholesale medicines however they facilitate the sale or purchase and negotiations between their clients. Do you ever buy or sell through a Broker? Is your Broker registered ? From next year the new EU GDP guidelines will be updated and your broker...
Technical Agreements (TAs)? Time to review them ?
When did you last review your Technical Agreements with your suppliers, your logistics companies and your customers? Do they clearly define each parties responsibilities? Are there any unclear areas? Do they cover all eventualities? In the TAs with your logistics...