Deputy Regulatory Affairs Manager Interview Questions and Answers

CEP approval timelines vary depending on the complexity of the application and the workload of the EDQM.

• CEP applications are reviewed by the European Directorate for the Quality of Medicines (EDQM)

• The review process can take anywhere from 6 to 18 months

• The complexity of the application and workload of the EDQM can affect the timeline

• CEP approvals are valid for 5 years and can be renewed

• CEPs are recognized by regulatory authorities in over 40 countries

The guidelines followed for nitrosamine limits are set by regulatory agencies such as FDA, EMA, and ICH.

• Nitrosamine limits are set by regulatory agencies to ensure the safety of pharmaceutical products.

• FDA has set a limit of 96 ng/day for nitrosamines in certain medications.

• EMA has set a limit of 26.5 ppm for nitrosamines in sartan medicines.

• ICH has issued guidelines for the detection and control of nitrosamines in pharmaceuticals.

Deficiencies in regulatory compliance are increasing due to stricter regulations and increased scrutiny.

• Stricter regulations are being implemented by regulatory bodies

• Increased scrutiny by regulatory bodies

• Non-compliance with regulations due to lack of understanding or resources

• Increased focus on data integrity and quality

• Increased emphasis on risk management

• Examples include FDA warning letters for data integrity issues and EU MDR non-compliance