...request ID. This often still works at Investigator Site inspections and single site organisations which work in paper themselves day to day. However, for large organisations we have found that...
...standards that other international regulators will follow (eg through contributions to EU and national legislation and guidance) providing advice and education to stakeholders to improve systems and compliance taking action...
...been stored and should be signed by an authorised and identifiable signatory. A trained person at the wholesalers should examine the returned product to check for tampering and to confirm...
...to perform risk-based supervision of sites by either on-site or remote inspections and, based on the outcome, may continue to issue, withdraw or restrict GMP and GDP certificates as appropriate....
...UK there is no regulatory requirement for the QP to be physically present at the site of manufacture or importation to perform the certification process for an individual batch. MHRA...
...it relates to. 4. Be specific about which company/site a query relates to It helps us to know which site a query relates to. Several companies operate at different site...
...and records to assess the maturity of our systems in regard to each indicator on a scale of 1-5. A rating of 1 is equivalent to little or no system...
...legitimate supply chain. In a separate post, Lead Senior GDP Inspector Tony Orme describes measures that wholesalers can take to reduce the chance of dealing with unauthorised suppliers or customers....
...to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the public. Any activities of procurement and supplying must take place on sites named on a wholesale...
...inspections! The attitude and behaviour of senior management in these situations has unfortunately been seen to ‘trickle down’ to the shop floor resulting in poor compliance, sometimes to the surprise...
