This paper describes the creation of a specification sheet and a qualification plan for a GMP-compliant facility for stability studies.
The facility for stability studies is part of the newly incorporated stability laboratory of the company CELLsius. For the creation of the documents, particularly the legislative texts AMBO 2009, AMG, the EU-GMP-Guidelines and the ICH-Guidelines, with a main focus on ICH-Q1 (stability) were important. The most important components of the specification sheet are the constant climate chambers, which are the central part in the stability laboratory. Through an adequate qualification with DQ, IQ, OQ and PQ, the realisation and operation will run under low risk.