IFPI Working Groups focus on issues related to the activities of pharmaceutical inspectorates and the conduct of pharmaceutical inspections for compliance with good manufacturing practice (GMP) requirements.

19 National Regulatory Authorities are members of IFPI Working Groups.

Main topics:

• requirements for the inspectors qualification and work experience;
• assessment of inspectors performance;
• problems related to hiring new employees and ways to solve them;
• training of inspectors and assessment of training effectiveness.

Inspector Qualification and Training

Main topics:

• major differences between QS of different inspectorates;
• potential impact of QS differences on the availability of medicinal products for patients;
• assessment of the inspectorate’s performance by an independent party.

Inspectorate Quality System (QS)

Main topics:

• single-use systems, integrity testing;
• sterile production clothing: preparation, requirements;

Manufacture of Sterile Medicinal Products

Online discussions

Offline meetings of the Working Groups members on the sidelines of the Forum

1 -3 quarter (first six months)

4 quarter (second six months)

Working Groups Schedule: