GMP for Manufacturers of Active Pharmaceutical Ingredients

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Good Manufacturing Practice is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production process that cannot be eliminated through test... Read More

Good Manufacturing Practice is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production process that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, production process, production controls, packaging , labeling, storage, premises and equipment to the training and personal hygiene of staff.

This involves ensuring that systems are in place to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. GMP compliance is widely-accepted as the best way to conduct business, putting product quality first. Implementation of GMP is an investment in good quality product. It is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur.

Standards governing the production of pharmaceutical products require that all staff involved in drug manufacture receive ongoing training in Good Manufacturing Practices. This training programme examines the need for GMP, the benefits of GMP in our daily tasks, the 10 principles of GMP and the specific requirements of either EU GMP Part II or FDA CFR Part 211.

This programme can be customised to accommodate specific in house challenges and exercises can be developed around these in order to enhance the learning experience.

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What's covered?

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  • Introduction to GMP
  • 10 Principles of GMP
    • Facility Design
    • Validated Processes
    • Good Procedures
    • Identify Responsibility
    • Effective Record Keeping
    • Personnel Training & Competency
    • Good Hygiene
    • Maintain facilities & equipment
    • Build quality into the whole product lifecycle
    • Perform regular audits
  • Specific requirements of EU GMP Part II or FDA CFR Part 211

Who should attend?

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Any person within the organisation involved in API manufacture, implementation of quality systems  or personnel responsible for GMP compliance

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Understand the requirement for GMP
  • Understand the benefits of GMP in performing daily tasks within this industry
  • Awareness of the important role personnel play in GMP while performing their everyday tasks
  • Understand the key principles of GMP
  • Understand the specific requirements of either EU GMP Part II or FDA CFR Part 211.

Who are the tutors?

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SnapshotSnapshot

Duration
1 training day
Course Times
9.00am - 5.00pm
Delivery Mode
This programme is available In-House

GMP for Manufacturers of Active Pharmaceutical Ingredients

Duration: 1 day
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