Good Manufacturing Practices for Medicines and GMP inspections
There is currently a strong momentum for the strengthening of the local pharmaceutical sector in developing and emerging markets. Regional and national strategies to promote local pharmaceutical production in line with international standards are being developed.
While the rationale for local production is simple - including factors such as independence from donor programmes which may not run forever, more steady supply chains, and greater control to local regulators - there is still a long way to go and markets are tough. Local companies, especially in low and middle income countries, often face substantial hurdles.
One of the big challenges is the lack of a qualified human resources base in the manufacturing sector of medicines and other healthcare products. In particular, there is need for skilled personnel for quality units (quality assurance, quality control) and other GMP relevant areas. Costs for bringing in experts from abroad are high. Combined with other challenges, local manufacturers often struggle to compete and even survive. Not being in line with international quality standards, they are prevented from passing WHO prequalification, participating in international tenders, and entering international markets.
Moreover, the national medicines regulatory agencies (NMRAs) of these countries experience a shortage too of qualified staff in GMP, GMP inspection and dossier evaluation. This creates difficulties for the NMRAs to enforce internationally acceptable regulatory requirements (including GMP standards) thereby preventing the availability of affordable quality generics for the majority of their low income population groups.
This e-learning course introduces Good Manufacturing Practices for medicines. The course focuses on WHO GMP standards and requirements as one of the major GMPs. Course participants will learn about GMP requirements, including procedural, organizational and infrastructural aspects, as well as about the GMP inspection process. They will be able to critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment. The participants will practice course contents in quizzes, assignments, and discussion forums.
In the end, these capacity building measures in the area of GMP and GMP inspection will make participants from local manufacturers and national regulatory authorities better equipped for production and regulation of quality assured essential medicines in line with national and international standards.
After having successfully completed the course, participants will be able to:
- Appreciate the importance and need for good manufacturing practices.
- Be familiar with the development of medicines regulation.
- Understand the main requirements in GMP, including procedural, organizational and infrastructural aspects.
- Critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment.
- Understand the need for, and the benefit of GMP inspections.
- Be familiar with different types of GMP inspections.
- Interpret and discuss the role of GMP inspectors.
- Understand the inspection process and structure of an inspection report.
Target participant group
The course is designed mainly for individuals and organisations in GMP-relevant areas and GMP inspectorates, both those with professional experience who want to deepen and update their knowledge, as well as young professionals who want to prepare intensively for their tasks.
Teaching and learning strategy
The course is taught online on i+academy, a Moodle e-learning platform, accessible from anywhere at any time. The interactive course materials are presented sequentially under the guidance of expert facilitators from i+solutions who assist the participants during their learning progress, answer questions and stimulate interactions. Lessons are complemented and enlivened by online activities such as discussion forums, quizzes, and assignments.
Assessment and grading
Participants will be graded based on their online participation and their performance. A certificate of completion and an e-badge will be awarded to all those who complete a minimum of 75% of all online activities (lessons, quizzes, discussion forums) AND attain a grade of at least 7/10 on the end-of-course quiz. The percentage of completion will be measured automatically online as the participant goes through the course. The grade of the end-of-course quiz will also be determined automatically, there are an unlimited number of attempts allowed. In addition, there are several non-graded activities such as short assignments and short quizzes to guide the learning process of the participants.
Start date: Monday, 22 April 2019 13:00 (UTC)
End date: Monday, 3 June 2019 13:00 (UTC)
Level of effort: 4 hours per week
|Week 1||Development of medicines regulations
Good manufacturing practices
|Week 2||Quality management
Personnel, organisation and training
|Week 3||Sanitation and hygiene
Good practices in production and quality control
Qualification and validation
|Week 5||GMP requirements for documentation
Complaints and recalls
Self inspection and quality audits
|Week 6||Introduction to GMP inspections
The role of the inspector
Types of GMP inspections
Inspections and inspection report