Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are a set of guidelines and principles designed to ensure the quality, safety, and efficacy of manufactured products, particularly pharmaceuticals, medical devices, and foods. GMPs cover a wide range of aspects, including production processes, quality control, documentation, and personnel training.
Good Manufacturing Practices (GMP) are essential for ensuring the quality, safety, and efficacy of manufactured products. They provide a framework for organizations to follow to minimize the risk of contamination, errors, and defects in their products.
Here are some of the key reasons why GMP is important:
- Product quality: GMP helps ensure that products are manufactured to the highest standards, meeting the needs and expectations of consumers.
- Consumer safety: GMP helps prevent the introduction of harmful contaminants or defects into products, protecting consumers from health risks.
- Regulatory compliance: GMP is often a requirement for obtaining regulatory approval to manufacture and sell products in certain industries.
- Market access: Compliance with GMP can help organizations gain access to new markets and customers.
- Brand reputation: A strong commitment to GMP can enhance an organization’s reputation as a reliable and trustworthy manufacturer.
- Cost savings: GMP can help reduce waste, rework, and recalls, resulting in cost savings for the organization.
- Continuous improvement: GMP provides a framework for organizations to continuously improve their manufacturing processes and quality systems.
By implementing and following GMP guidelines, organizations can demonstrate their commitment to quality and safety, protect their customers, and improve their overall business performance.
- Improved product quality and safety: Ensure that products meet regulatory requirements and are safe for consumers.
- Enhanced regulatory compliance: Avoid regulatory actions and penalties by demonstrating compliance with GMP standards.
- Increased customer confidence: Build trust with customers by demonstrating a commitment to quality and safety.
- Improved operational efficiency: Streamline manufacturing processes and reduce waste.
- Career advancement: Gain valuable knowledge and skills that can enhance your career prospects.
QASI is excited to support you, contact us to begin with the first step!
Explore our courses and find the perfect fit for your needs.
- Good Manufacturing Practices (GMP)– Implementers’ course
- Good Manufacturing Practices (GMP)- Auditors’ course based on ISO 19011
Good Manufacturing Practices (GMP) training is suitable for a wide range of individuals working in industries that require adherence to quality and safety standards. This includes professionals from the following fields:
- Pharmaceutical industry: Pharmacists, pharmaceutical scientists, quality control analysts, production engineers, and regulatory affairs professionals.
- Medical device industry: Biomedical engineers, quality assurance specialists, and regulatory affairs professionals.
- Food industry: Food scientists, food technologists, quality control personnel, and food safety managers.
- Cosmetics industry: Cosmetic chemists, quality control analysts, and regulatory affairs professionals.
- Biotechnology industry: Scientists, researchers, and quality control personnel working with biological products.
- Regulatory agencies: Government officials involved in enforcing GMP regulations.
- Consultants: Professionals who provide advice and guidance on GMP implementation.
Training Days for each course: 5
Exam Duration: 1 hour
Retake Exam: Yes
For additional information, please contact info@qasi.co.ug
Good Manufacturing Practices (GMP)- Implementers’ course
ABOUT THIS COURSE
Course Description
- The Good Manufacturing Practices (GMP) Implementers’ course is designed to equip individuals with the knowledge and skills necessary to establish, implement, maintain, and continually improve a GMP system within an organization. GMPs are a set of guidelines and principles that ensure the quality, safety, and efficacy of manufactured products, particularly in industries such as pharmaceuticals, medical devices, and food.
Key topics covered in the course include:
- GMP principles and concepts: A comprehensive understanding of the fundamental principles of GMP and their application to various industries.
- GMP regulations: An overview of relevant GMP regulations and standards, such as FDA, EMA, and ISO standards.
- Documentation and record-keeping: The importance of accurate and complete documentation in GMP compliance.
- Production processes: good practices for manufacturing, packaging, and labeling products.
- Quality control: Methods for ensuring the quality of raw materials, intermediate products, and finished goods.
- Personnel training and qualification: The importance of qualified and trained personnel in GMP compliance.
- Facility design and maintenance: Requirements for cleanrooms, storage areas, and other facilities.
- Complaints and recalls: Procedures for handling complaints and conducting recalls.
Course objectives:
Participants will be able to:
- Establish and implement a GMP system that meets regulatory requirements.
- Develop and implement quality control procedures.
- Ensure the safety and efficacy of manufactured products.
- Conduct internal audits of the GMP system.
- Continuously improve the GMP system to enhance product quality and compliance.
Certification
Participants get certificate of successful course completion awarded at the end of the training.
Minimum requirements for certification will include: 95% attendance of the sessions and at least 70% in the post-test. Participants who fail to meet the criteria above get a certificate of participation.
Resource Material
- FDA GMP Regulations
- EU GMP Guidelines
- ISO 9001:2015
- International Society for Pharmaceutical Engineering (ISPE)- GMP guidelines
- World Health Organization (WHO)-GMP guidelines
Who Should Attend:
Participants include:
- Pharmaceutical manufacturing
- Medical device manufacturing
- Food manufacturing
- Cosmetics manufacturing
- Biotechnology
Course Prerequisites
- Quality management principles: A general understanding of quality management concepts, such as customer focus, process approach, continuous improvement, and evidence-based decision-making.
- Manufacturing processes: Familiarity with basic manufacturing processes and terminology.
- Regulatory requirements: Awareness of relevant GMP regulations and standards for your industry.
Good Manufacturing Practices (GMP)- Auditors’ course based on ISO 19011
ABOUT THIS COURSE
Course Description
- The GMP Auditors’ course based on ISO 19011 is designed to equip individuals with the knowledge, skills, and techniques necessary to conduct effective audits of GMP systems within organizations. This course provides a comprehensive understanding of GMP principles, auditing methodologies, and the application of ISO 19011 standards to GMP audits.
Key topics covered in the course includes:
- GMP principles and regulations: A comprehensive overview of GMP regulations and standards applicable to various industries, such as pharmaceuticals, medical devices, and food.
- ISO 19011 auditing principles: The fundamental principles and techniques for conducting effective audits, as outlined in the ISO 19011 standard.
Course objectives:
Participants will be able to:
- Conduct effective GMP audits that conform to ISO 19011 standards.
- Identify nonconformities and recommend corrective actions.
- Evaluate the effectiveness of GMP systems.
- Contribute to the continuous improvement of GMP practices within organizations.
Certification
Participants get certificate of successful course completion awarded at the end of the training.
Minimum requirements for certification will include: 95% attendance of the sessions and at least 70% in the post-test. Participants who fail to meet the criteria above get a certificate of participation.
Resource Material
- GMP- guidelines
- ISO 19011
- Hand-outs and course material will be supplied to all participants.
Who Should Attend:
Participants include:
- Internal auditors
- External auditors
- Quality managers
- Regulatory affairs professionals
- Industry experts
Course Prerequisites
- GMP principles and regulations: A general knowledge of GMP regulations and standards applicable to various industries.
- ISO 19011: Familiarity with the principles and techniques for conducting audits, as outlined in the ISO 19011 standard.
- Quality management systems: A basic understanding of quality management systems and their principles.
- Auditing concepts: Knowledge of auditing principles, such as evidence collection, objective evaluation, and reporting.
- Manufacturing processes: Familiarity with basic manufacturing processes and terminology.
Who should attend?
Good Manufacturing Practices (GMP) training is suitable for a wide range of individuals working in industries that require adherence to quality and safety standards. This includes professionals from the following fields:
- Pharmaceutical industry: Pharmacists, pharmaceutical scientists, quality control analysts, production engineers, and regulatory affairs professionals.
- Medical device industry: Biomedical engineers, quality assurance specialists, and regulatory affairs professionals.
- Food industry: Food scientists, food technologists, quality control personnel, and food safety managers.
- Cosmetics industry: Cosmetic chemists, quality control analysts, and regulatory affairs professionals.
- Biotechnology industry: Scientists, researchers, and quality control personnel working with biological products.
- Regulatory agencies: Government officials involved in enforcing GMP regulations.
- Consultants: Professionals who provide advice and guidance on GMP implementation.
Other Information
Training Days for each course: 5
Exam Duration: 1 hour
Retake Exam: Yes
For additional information, please contact info@qasi.co.ug