QA, QC, GXP for Pharmaceutical Production

There is a need for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. We aim to give an overview of existing legislation related to quality systems, and further, on the efficient implementation of such systems.

The course is intended for MIND students, MPRA students and other drug development professionals who are working within drug development and manufacturing related activities, and who need basic knowledge about legislation within drug development.

The course contains a proper review of the relevant national and international legislation followed by lectures on how the pharmaceutical industry implements the quality system for practical use. The structure and content of a quality manual is described. Also the QA and QC activities for companies with marketed products are presented with the main focus on GMP.

Topics read:

• International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD
• National legislation GXP: Medicines Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling.
• Manufacturers authorization, authorization to handle euphoriant substances. Company quality manual: Policies, guidelines, SOP's, work instructions.
• QA/QC activities (GMP): Site master file, Audit of suppliers; self-inspection; deviation and change control systems; third party audits; authority inspections; handling of complaints and recall; qualification/validation activities including document approval and authorization; SOP's approval and authorization; GXP training and documentation; harmonization of GXP activities within a company (laboratories/production); specifications; release of packaging materials; release of starting materials; release of API (Active Pharmaceutical Ingredients); release of finished products; certificates of analysis (COA); Certificate of Compliance (COC).
• QA/QC activities (GCP and GLP): Monitoring and audits.
• QA/QC activities (GDP)
• Participation in industries association working groups discussing new legislation and harmonization of QA/QC activities, national and international.