GMP for Manufacturers of Active Pharmaceutical Ingredients

This programme is available In-House and currently delivered through virtual classroom training.

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. Regulations governing the production of pharmaceutical products require that all staff involved in drug manufacture receive ongoing training in Good Manufacturing Practices. This programme is customised for each company in order accommodate specific in house challenges they are experiencing. This course material is put together based on the clients information, trends, pictures etc in order to illustrate the positives and weaknesses of practices & GMP within their facility. Generally, an on-site visit is performed first in order for the tutor to gain an understanding and some experience in the specific areas the company would like covered. Exercises can be developed around these in order to enhance the learning experience.

Delivery Mode

  • Customised
    In-Company
    Programmes

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Course Code
LS014

What's covered?

These are topics that can be included, however these can be changed based on the company’s own specific needs and requirements.

  • Introduction to GMP
  • GMP Licence
  • 10 Principles of GMP
    1. Facility Design
    2. Validated Processes
    3. Good Procedures
    4. Identify Responsibility
    5. Effective Record Keeping
    6. Personnel Training & Competency
    7. Good Hygiene
    8. Maintain facilities & equipment
    9. Build quality into the whole product lifecycle
    10. Perform regular audits
  • Previous Audit Findings
  • Specific requirements of EU GMP Part II or FDA CFR Part 211 for the above topics are referenced throughout the course material.

Who should participate?

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

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • Understand the requirement for GMP and the importance of maintaining our licence
  • Understand the key principles of GMP (specific to the company’s requirements)
  • Understand the benefits and the need for GMP in performing daily tasks within this industry
  • Awareness of areas of GMP that may need improvement
  • Understand the specific requirements of either EU GMP Part II or FDA CFR Part 211.

Who are the tutors?

Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She understands that supporting you effectively means meeting challenges and deadlines, understanding your specific needs, communicating effectively with you and providing accurate and honest advice, with integrity and confidentiality.

Kevina is a PhD graduate from the National University of Ireland, Galway. Since graduating she has worked in the life science industry for 20 years, both nationally and internationally. Beginning in the diagnostics sector, working for Cambridge Diagnostics she then moved to the medical device sector working for Abbott Vascular, Galway. Here she worked as a Microbiologist and was closely involved in the setting up, validation and monitoring of cleanroom environments.

Kevina delivers training programmes on many different topics related to Auditing, CE Marking, Quality Standards, Cleanroom Controls and Behaviours, GMP, as well as developing bespoke training programmes to meet specific client’s needs. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way thus allowing the learners to achieve their learning goals successfully.

In addition to providing expert training, Kevina routinely works as a consultant and auditor. Kevina has the expertise to deal effectively with both Cleanroom, Quality and Regulatory related issues. Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. With the wealth of experience Kevina has accumulated to date working with many different companies, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively to ensure understanding.

Kevina provides key support to both start up and multinational companies. She is an accomplished trainer with a Certificate in Training and Continuing Education from NUI, Maynooth and has also successfully completed QMS Auditor / Lead Auditor training.


How do we train and support you?

In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Kevina O’Donoghue

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Kevina O’Donoghue

Duration: 1 day
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