Understanding Quality Management

Quality Management System

Lema Project Management LLC provides quality control, quality control and quality assurance services. Advise on the implementation of good practice (or GxP) guidelines and ensure compliance.

A pharmaceutical quality management system covers all aspects of a product's life cycle, from development to patient use. Quality assurance measures known as 'good practice' are implemented at every stage.

These include Good Manufacturing Practice (GMP) guidelines, first published by WHO in 1968 and subsequently revised and expanded several times. The EU GMP Guide provides an overview of the GMP regulations applicable in the European Union.

There are similar EU Directives on Good Distribution Practice (GDP) and Good Pharmacovigliance Practice (GVP). A company's Qualified Person (QP) or Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring compliance with the GxP guidelines.

Lema Project Management LLC supports pharmaceutical companies and their QPs in efficiently integrating these standards into their quality management systems, complying with GxP guidelines, and demonstrating regulatory compliance during inspections. We develop a complete GxP quality management system and provide quality assurance advice. Eligible person: we take responsibility