Good manufacturing practice: the role of local manufacturers and competent authorities.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enf...

Competent Authorities to Handle Complaints about Incorrect Tax Assessment and Collection with an Ethical Approach in Iran

Background: Retrial is an additional combination of the words "retrial" and "trial". Trial is a means of justice and trial, like others, is in the introduction of error and error if there is a verdict that is accompanied by error as a result of the trial. Which must be reconsidered. In the relations between taxpayers and the tax system, a dispute is possible, which can be due to factors such as...

Roadmap for Lean implementation in Indian automotive component manufacturing industry: comparative study of UNIDO Model and ISM Model

The demands for automobiles increased drastically in last two and half decades in India. Many global automobile manufacturers and Tier-1 suppliers have already set up research, development and manufacturing facilities in India. The Indian automotive component industry started implementing Lean practices to fulfill the demand of these customers. United Nations Industrial Development Organization...

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

Safety of in vitro Diagnostics for Hematology and Coagulation Testing – Analysis of the Reports to the German Competent Authority (BfArM)

The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and postmarketing surveillance of IVD in the European Economic Area. In case of incidents and field-corrective actions related to IVD, manufacturers have to inform the responsible competent authorities. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible c...