by Adel Nagy | Apr 3, 2017 | Blog, Brexit, Transportation
Exactly a year after the Brussels attack sadly an attack happened in our warmly loved capital London. We can never be prepared for such tragic event. An attach can have effects such as closure of roads, ports and airports or long delays for days or maybe for week...
by Adel Nagy | Feb 15, 2017 | Blog, Falsified Medicines
Have only two years to prepare for FMD compliance. EU FMD specifically outlines how the EU will track and trace medications using serialisation, government reporting, and verification components. This time last year (February 2016) the Delegated Act was...
by Adel Nagy | Feb 13, 2017 | Blog, Bona Fides, Business, Consultancy, EudraGMDP, Falsified Medicines, Good Distribution Practice - GDP, Humidity, MHRA, Quality Systems, Regulation, SOPs, Transportation, WDA(H)
Having trouble gathering all the necessary information about your customer or supplier? Getting ready for Inspection? Short of time? Having difficulties? PCL have many years of experience in bona fide checks. We offer different levels of help: Bespoke Bona fide Team...
by Adel Nagy | Dec 12, 2016 | Blog
Product quality is the responsibility of all parties involved in the development, manufacturing, testing, packaging, distribution and regulation of materials that make up the clinical or commercial drug product. “outsourced should be appropriately defined, agreed and...
by Adel Nagy | Oct 7, 2016 | Blog
The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person for GDP activity. Taking part of many inspections one of the key area the auditors looking is how the roles and responsibilities of key personnel...