Your premises must be registered with the General Pharmaceutical Council (GPhC) if your business model includes any of the following
- The sale of Pharmacy (P) medicines
- The supply of P medicines or Prescription Only Medicines (POMs) against prescriptions.
- The supply of P medicines or Prescription Only Medicines (POMs) against prescriptions written by veterinary practitioners for the treatment of animals under the ‘cascade’.
Standards for Registered Pharmacies
These are designed to strengthen the regulation of pharmacies and improve the quality of pharmacy practise.
They move away from a prescriptive or rules-based approach and focus on what pharmacies are achieving for patients and people who use pharmacy services.
The standards are set out under five principles which describe arrangements for safe and effective pharmacy care.
Principle 1 – looks at identifying and managing risks in your pharmacy
Principle 2 – looks at staffing issues
Principle 3 – is about the pharmacy premises
Principle 4 – is about delivery of pharmacy services
Principle 5 – is about equipment and facilities.
Pharmacy owners and superintendents (when the pharmacy is company owned) are accountable for how well the standards are being achieved.
A New Approach to Inspection
The GPhC has developed a new risk based approach to pharmacy inspections. The regulators will be making sure that the patients and the public are at the heart of the inspection and that the outcomes from pharmacies meet their needs.
The inspectorates will look at the pharmacy as a whole and not just at documentation. They will speak to the team and use a show and tell approach to see how the outcomes are working for the patients. The pharmacy will be judged and a report will be produced showing whether the result was ‘poor’, ‘satisfactory’, ‘good’ or ‘excellent’.
Why Consider Us for your GPhC Registration / Inspection?
With over 50 years’ experience in the pharmacy sector working for a variety of different business models from large Community Pharmacy chains to small independent Distance Selling Pharmacies we have helped a number of clients obtain their GPhC licence.
We can support you in your registration process and provide a contract Superintendent Pharmacist if needed.
We can help you prepare for your pharmacy’s inspection by carrying out a mock audit and producing an improvement action plan ensuring you achieve an excellent report and thus minimising the corrective actions implemented by the GPhC. Moving forward the GPhC will be publishing the results of their inspections so an excellent inspection will definitely be beneficial to your business.
Our services are listed below:
- Review and update your Standard Operating Procedures
- GAP analysis, creation of robust and validated action plans
- Regular reviewing and updating of your system to identify and manage risks but also to find out more opportunities
- Job descriptions for all your personnel
- Identify suppliers or contractors
- Recruitment competent and trained staff to meet their professional and legal obligations, support for oversees pharmacist
- Cold chain validation/ support
If you need further information contact us.