Fimea to host the international PIC/S 2020 seminar for GMP inspectors
Fimea will host the international PIC/S 2020 seminar for GMP inspectors this year. The annual PIC/S seminars are closed training and discussion events for inspectors of pharmaceutical plants. The seminars are also intended to promote and harmonise the activities of inspectors around the world. The seminar will be arranged for the first time as a completely virtual event on 8–10 December 2020 under the theme “Distant Assessment of GMP Compliance”.
Distant assessments refer to GMP inspections to ensure good pharmaceutical manufacturing practice in pharmaceutical plants which are carried out without physically visiting the site. The inspections assess the pharmaceutical plant's systems and facilities remotely by e.g. interviewing staff.
Fimea offered to host the 2020 seminar on a short notice following the original host’s withdrawal from its hosting responsibilities due to the corona pandemic situation.
"Distant assessments as the topic of the PIC/S seminar is particularly relevant to all inspectors." Mervi Saukkosaari says that Fimea has been involved in developing both its own and EU's integrated distant assessment operations.
PIC/S harmonises inspection activities and trains inspectors
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organisation that currently has 53 pharmaceutical regulatory authorities from around the world as its members. PIC/S harmonises inspection procedures, prepares guidelines and trains inspectors. The annually arranged PIC/S seminar and committee meeting are hosted in turn by different Member States.
Finland was one of the founding members of the organisation in 1971. Finland hosted the PIC/S seminar for the last time in 1997, on which occasion GMP inspections by pharmaceutical manufacturers was addressed as a new theme of current interest.
- Mervi Saukkosaari, Senior Inspector, Head of Division, tel. + 358 29 522 3261
- Johanna Nystedt, Director, Supervision of pharmaceutical operators, tel. + 358 29 522 3210
- Eeva Leinonen, Head of Unit, Inspectorate, tel. + 358 29 522 3220
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