The first "GMP Report" covers "FDA Requirements for cGMP Compliance". Twelve Authors from the pharmaceutical industry illustrate the efficient implementation of FDA's cGMP requirements in routine operations.
The "GMP REPORT" is a new publication series. It is published in English language. The reports support the implementation of current GMP guidelines in pharmaceutical operations. There are no fixed publishing intervals or periods; as a rule, two volumes per year are issued.
Please note: The GMP Report is not an ECA publication. However, ECA supports this series as we believe that a European publication in the field of GMP Compliance has been missing for many years. The GMP REPORT is published by ECV · Editio Cantor Verlag, Aulendorf (Germany). Your purchase order will be forwarded to and effected by the ECV.
In the GMP Report No 2 "The Qualified Person", an overview of the applicable European legislation framework and relevant guidelines is given. The legal duties of the QP like batch certification are introduced and discussed. The aspect of the QP’s discretion in certifying a batch in the case of deviations and OOS results, the possibility of delegating tasks, the responsibilities within the quality system and also necessary skills a QP needs for the daily business are reflected in various articles.
Experts from international pharmaceutical companies as well as from the national authorities will share their experience on these issues and will give first-hand information of what is expected from QPs nowadays and in the future.
A working risk evaluation system is a key element of drug safety. This is valid for industry as well as for licensing and inspecting authorities.
Risk assessment is a legal obligation. The state of the art is discussed on international level and is laid down in GMP guidelines which have to be observed by all involved parties.
In German QA documents for competent authorities these principles were transferred into SOPs for inspectors.
Pharmacovigilance and pharmaceutical-technical procedures are subject to a risk assessment system. Indications and drug characteristics have an influence on potential risks of the particular measures. During the production process QA systems and periodic quality reviews ensure that each product and each process is assessed continuously.
Inspectorates are subjected to inspection planning and the conduction of inspections according to a risk assessment system. Failure evaluation and corrective actions are risk orientated
*All prices plus postage, packing, and VAT (if applicable)