The manufacture of pharmaceutical products requires the
establishment and implementation of an effective Pharmaceutical Quality System (PQS). The PQS must be appropriate for the activities performed, be fully documented and monitored to ensure effectiveness.
Without an effective PQS, the QP cannot be sure that the required, inter-related systems remain in control and that each batch of product has been manufactured according to both the relevant licence requirements and GMP. This module is designed to cover establishment, implementation and effective operation of a PQS as well as giving practical guidance on all major elements of a typical PQS. It will focus on the challenges associated with each major element and how these can be effectively addressed.
establishment and implementation of an effective Pharmaceutical Quality System (PQS). The PQS must be appropriate for the activities performed, be fully documented and monitored to ensure effectiveness.
Without an effective PQS, the QP cannot be sure that the required, inter-related systems remain in control and that each batch of product has been manufactured according to both the relevant licence requirements and GMP. This module is designed to cover establishment, implementation and effective operation of a PQS as well as giving practical guidance on all major elements of a typical PQS. It will focus on the challenges associated with each major element and how these can be effectively addressed.
