Inspection Readiness and Successful Execution.
Lesley Maughan and Martin Mewies Regulatory Consultants with Woodley BioReg, have published a joint article in latest edition of TOPRA’s Regulatory Rapporteur entitled “ Inspection readiness and successful execution ”.
“Inspections by competent regulatory authorities are a fact of life for manufacturers of pharmaceutical products and medical devices, to assure compliance, conformance and integrity of the finished product(s). Understanding what is required for a state of inspection readiness enables an organisation to be able to present itself in a positive and accurate manner. The necessary processes and roles in advance, during and after an inspection are presented and discussed.”
In the article they talk about the “panacea for the pharmaceutical sector” being a” state of constant inspection readiness”. The reality where a culture of good practices, with the proper processes and procedures in place, will allow for a smooth transition into inspection readiness.
To find out more and read the full article Inspection Readiness – TOPRA RegRapp FEB18
