GMP for Manufacturers of Finished Pharmaceuticals

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, 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 product 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-House
    Programmes

    Contact Us

SnapshotSnapshot

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
    • 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
  • Previous Audit Findings
  • Specific requirements of EU GMP or FDA CFR Part 211 for the above topics are referenced throughout the course material.

Who should attend?

Any person within the organisation involved in pharmaceutical product 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 the GMP 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 or FDA CFR Part 211.

Who are the tutors?

Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National University of Ireland, Galway with 10+ years experience working as a Microbiologist and 7+ years as a trainer, auditor and consultant, she has the expertise to deal effectively with both Cleanroom and Quality related issues. She is experienced in problem solving, reviewing and critically analysing documentation, investigating non-conformances, writing reports, meeting deadlines and working with various teams. She is skilled in dealing with human related issues and has an admirable way of interacting and engaging at an interpersonal level with people at all levels of the business. With the wealth of experience Kevina has accumulated to date working with many different life science companies both nationally and internationally, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively, to ensure understanding.

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. Her main focus is on improvements rather than non-conformances, giving businesses a clear, objective insight into their current conformance status and constructive feedback on how to improve and ensure business goals are achieved successfully. Her interpersonal skills, allied with her excellent communication skills make her a very effective trainer. 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.

Kevina is engaging, enthusiastic and very passionate about her work. Confidentiality and professional impartiality are strong values and principles that she works to at all times.


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

Duration: 1 day
Hide

Contact SQT today