by Paradigm Shift Consulting | Jan 28, 2021 | GDP
What are Outsourced Activities? Outsourced activities are any activities that are carried out for you by a third-party. For all outsourced activities there should be an in-depth written contract in place that clearly lays out the duties and responsibilities of both...
by Paradigm Shift Consulting | Jan 21, 2021 | Management, GDP, MHRA, Responsible Person, Training, Warehouse
An effective Quality Management System is essential for ensuring that your operations are GDP compliant. What is a Quality Management System? Your Quality Management System (QMS) will lay out everything that you need to do and includes all procedures, processes,...
by Paradigm Shift Consulting | Jan 6, 2021 | GDP, Change Control, Data, Deviations, Documentation, Management, Responsible Person, Temperature Management, Training, Warehouse
What are Standard Operating Procedures? Standard Operating Procedures (SOPs) are the documents that will set out all of the procedures used by your company, meaning they should mirror these processes. They are the backbone of your company’s Quality Management...
by Paradigm Shift Consulting | Dec 18, 2020 | GDP, Training
What is a CAPA? A Corrective and Preventive Action (CAPA) is taken to correct existing (corrective) or potential (preventive) deviations occuring or reoccuring in all and any areas of Good Distribution Practice compliance and procedures. If done correctly this...
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...
