QA QC GXP for Pharmaceutical Production

This course is for you if you have an academic background with little or no knowledge of the different stages of the quality within development of a drug product.

You will gain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas, i.e. Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice.

The course is relevant for you aiming to gain a basic knowledge of the law / guidelines relevant for working in a GXP environment. Also, you will be able to see the link between the different areas of work, ex. activities related to testing in animals and in humans, pharmacovigilance, manufacturing and transportation of the drug product. You will experience that some of the laws / guidelines are quite similar between the different GXP areas, but varying in the focus and the way how they are interpreted.

Course content

This course is quite unique as most lecturers work in the pharmaceutical industry. Some lecturers work in the Danish Medicines Health Authority and are focusing on the latest trends within the inspection findings.

The course will cover these topics:

• International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD.
• National legislation GXP: Medicinal Products Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling, Euphoriant Act.
• Manufacturers authorization, authorization to handle euphoriant substances Company quality manual: Policies, guidelines, SOP's, work instruction.
• QA/QC activities (GMP): Site master file, Audit of suppliers; audits within the group; self-inspection; deviation and change control systems; third party audits; authority inspections; handling of complaints and recall including pharmacovigilance matters; 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.