cGMP - current Good Manufacturing Practice

Pharmaceutical Manufacturing Management Systems to US FDA requirements

AIM & OBJECTIVES

Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices.

The purpose of this course is to enhance awareness of the principles behind the GMP requirements so as to enable participants to contribute significantly to all aspects of compliance.

WHO SHOULD ATTEND?

The programme is intended for all managers, supervisors and other staff who wish to develop their knowledge of the practical implementation and maintenance of management systems in compliance with US FDA requirements.

cGMP for Medical Device, Cosmetics, Herbal Remedies and Animal Pharmaceutical Manufacture

The current course focuses on Pharmaceutical Manufacture. However, it can be readily modified to address the FDA requirements of cGMP in other industries.

PROGRAMME

As we are always pleased to customise the Programmes, the specific course content will depend on you particular needs.

The standard programme concentrates on the requirements for the pharmaceutical manufacture as follows...

Introduction
What is GMP?
The United States Food & Drug Administration (US-FDA) Version
WHO-GMP, EU-GMP & ICH
Enforcement
Other Good Practices Systems
Current Good Manufacturing Practice - CGMP
Why is GMP important?
The Regulatory Framework
- US FDA Regulations
- Organizational Structure
- Pharmaceuticals in the 21st Century
- EMEA Regulations
- Regulatory Documentation
Organizational Structure
Authorization Procedures within the EU
Regulatory Framework – PIC/S and ICH
- PIC/S
- ICH – International Conference on Harmonisation
The cGMP Basics
- Part 211 – Subpart A: General Provisions
- Part 211 – Subpart B: Organization and Personnel
- Part 211 – Subpart C: Buildings and Facilities
- Part 211 – Subpart D: Equipment
- Part 211 – Subpart E: Control of Components and Drug Product Containers and Closures
- Part 211 – Subpart F: Production and Process Controls
- Part 211 – Subpart G: Packaging and Labeling Control
- Part 211 – Subpart H: Holding and Distribution
- Part 211 – Subpart J: Records and Reports
- Part 211 – Subpart K: Returned and Salvaged Drug Products
FDA guidance on a Quality Systems Approach to cGMP
Appendix A: Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations, 2006

THE de GRANDISON APPROACH

Training with us is different! We use action learning and emphasise interaction in the group through a highly trained facilitator.

Practical workshop exercises are used throughout.

LOCATION & DURATION

The standard Programme is of 7 hours. This course is usually delivered as an in-house programme.