Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

Experienced QA manager and consultant with over 30 years of expertise in quality assurance within the pharmaceutical industry, with a strong focus on GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice).

Johan Hamminga has extensive experience in designing and optimizing quality management systems, preparing for and following up on regulatory inspections, and providing CMC support. Since 2016, Johan has been working as a Principal Consultant at Havem Pharma Consultancy, where he assists organizations in setting up and implementing quality management systems compliant with GMP and GDP standards.

He acts as a Responsible Person (RP) and conducts GMP and GDP audits and training. In addition, since 2021, he has been a trainer and auditor at PCS - Pharmaceutical Consultancy Services, performing site audits of pharmaceutical companies and providing on-site and off-site training on GMP, data integrity, and other quality-related topics.

Previously, Johan held leadership positions such as Director Quality Assurance at Allergan and Director Quality Assurance & Regulatory Affairs at Life Technologies. In these roles, he was responsible for quality oversight of contract organizations, establishing quality agreements, auditing, change control, deviations, and supporting CMC activities. With his extensive knowledge and experience, Johan helps pharmaceutical organizations enhance their quality and compliance levels, with special attention to GMP and GDP practices.

His skills in training, auditing, and quality management contribute to improving efficiency and compliance within the industry.

Experienced Qualified Person (QP), QA Specialist, and Responsible Person (RP) with a strong background in the pharmaceutical industry. Ali Aziz is the founder and owner of Pharmali Consulting B.V., where he has been offering consultancy services in quality assurance and regulatory compliance since August 2023.

Expertise and Services:

• Qualified Person (QP): Authorized for product release in compliance with applicable laws and regulations.
• Quality Assurance (QA) Specialist: Experienced in setting up and maintaining quality systems.
• Responsible Person (RP): Responsible for compliance with GDP guidelines in distribution processes.
• Consultancy: Providing advice and support in quality improvement and compliance efforts.

Previous Positions:

• Qualified Person Consultant at Abbott (August 2023 - Present): Responsible for quality assurance and product release at the Olst, Overijssel site.
• Senior Associate/Qualified Person at Janssen Biologics (Johnson & Johnson) (January 2022 - August 2023): Oversaw production processes and ensured product quality in Leiden.
• Qualified Person at MSD (May 2020 - January 2022): Responsible for batch release and document management in Haarlem.
• Senior QA Officer/QP/RP at Mylan (March 2018 - May 2020): Involved in root cause analyses and quality documentation in Amstelveen.
• Acting Pharmacist at VUmc (July 2018 - January 2020): Supported pharmaceutical care in a hospital setting.

Professional Involvement:

• Treasurer at the Association of Dutch Industrial Pharmacists (NIA) (March 2019 - June 2023): Managed financial administration and contributed to the professional development of industrial pharmacists.

Education and Skills:

• Pharmacist with a background in both community and hospital pharmacy.
• Skills: Root cause analysis, document management, GMP, GDP, quality control, and training.

Ali Aziz combines his expertise in quality assurance with practical experience across various sectors of pharmacy, making him a valuable partner for organizations aiming for high quality standards and regulatory compliance.