EU GMP Annex 1 Manufacture of Sterile Medicinal Products(2022년 8월 발행)이 개정발행되었습니다. 첨부를 참조하시기 바랍니다,

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4.32 The requalification of cleanrooms and clean air equipment should be carried out periodically following defined procedures.  The requalification should include at a minimum the following:

- Cleanroom classification (total particle concentration).

- Integrity test of final filters.

- Airflow volume measurement.

- Verification of air pressure difference between rooms.

- Air velocity test (Note: For grade B, C and D the air velocity test should be performed according to a risk assessment documented as part of the CCS. However, it is required for filling zones supplied with unidirectional airflow (e.g. when filling terminally sterilised products or background to grade A and RABS). For grades with non-unidirectional airflow, a measurement of recovery testing should replace velocity testing).

The maximum time interval for requalification of grade A & B areas, is 6 months.

The maximum time interval for requalification of grade C & D areas, is 12 months.

Appropriate requalification consisting of at least the above tests should also be carried out following completion of remedial action implemented to rectify an out of compliance equipment or facility condition or after changes to equipment, facility or processes as appropriate. The significance of a change should be determined through the change management process. Examples of changes to be considered include but are not limited to the following:

i. Interruption of air movement which affects the operation of the installation.

ii. Change in the design of the cleanroom or of the operational setting parameters of the HVAC system.

iii. Special maintenance which affects the operation of the installation (e.g. change of final filters).