Stephanie Blum

5 min. reading time | by Stephanie Blum

A management review is carried out on a regular basis to check the suitability and effectiveness of the pharmaceutical quality system (PQS). It is one of the most effective PQS tools available.

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)!

In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.

If a new service or material is required, the competent department first checks whether this service or material can be obtained from an already qualified supplier. If this is the case, the department initiates a follow-up qualification. Otherwise, the identification and pre-selection of potential new suppliers is carried out by the department itself.

Based on the risk assessment documented in the excipient dossier and the risk profile of the excipient, the risk team defines the necessary GMP requirements in the next step.

Pharmacopoeial standards are obtained by the chemicals officer from the issuing body and do not require further characterisation before use.