GMP for Manufacturers of Active Pharmaceutical Ingredients

Home / GMP / GMP for Manufacturers of Active Pharmaceutical Ingredients
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. 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.

Collapse

What's covered?

Expand/Collapse Expand/Collapse

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 Part II or FDA CFR Part 211 for the above topics are referenced throughout the course material.

Who should attend?

Expand/Collapse Expand/Collapse

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

What will I learn?

Expand/Collapse Expand/Collapse

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?

Expand/Collapse Expand/Collapse

How do we train and support you?

Expand/Collapse Expand/Collapse

In-House Courses
For In-House courses, the tutor will contact you in advance to discuss the course programme in more detail in order to tailor it specifically for your organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Share this Programme

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
Hide