by Paradigm Shift Consulting | Dec 17, 2020 | GDP
Does your Quality Management System (QMS) identify risks to product quality and patient safety? If not, then you need to start planning and implementing risk assessments immediately in all areas of your operations. The assessments do not need to be complicated; they...
by Paradigm Shift Consulting | Jun 24, 2020 | Change Control, Deviations, Documentation, GDP, Management, Non-Conformance, Responsible Person, RPi, Training
Change Control Processes A Change Control process will always need to be performed when changes are made to a system, piece of equipment or product. The process must ensure that all changes are identified, planned and implemented in a way that’s regulated and...
by Paradigm Shift Consulting | Mar 5, 2020 | Controlled Drugs, GDP, MHRA
Approval was given in 01 November 2018 for specialist providers to write scripts for Cannabis-Based Products for Medicinal Use (CBPM). Since then, there has been a lot of activity to get licenced. The Paradigm Shift Consulting office has received a number of enquires...
by Paradigm Shift Consulting | Jan 31, 2020 | Inspection, Auditing, GDP, Management, MHRA, Responsible Person, RPi, Training
Self-Inspection and Third-Party Audits are an important part of maintaining compliance throughout the company. During a self-inspection you should find any deviations or failures within your operations, and from there you can start to make improvements to your...
by Paradigm Shift Consulting | Jan 7, 2020 | Inspection, Auditing, Documentation, GDP, GMP, Licensing, Management, MHRA, Responsible Person, RPi
MHRA inspection – Be Ready! So what does this mean? MHRA inspection Preparation is important especially if you are worried about non-compliance. Carry out a self-inspection and compare your operations against the guidance, to ensure that you are compliant (at...
by Paradigm Shift Consulting | Nov 13, 2019 | Training, GDP, Management, MHRA, Responsible Person, RPi, Warehouse
Why is Competency Based Training Important? It is essential that every member of staff is confident in their role and understands how to follow procedures to effectively complete tasks in accordance with what is set out in the GDP guidelines, and competency must be...
