Aims and Objectives
This subject is designed to carry the principles of GMP to industrial situations and to further general exposure and GMP skills.
On completion of this subject students will be able to:
- State the specific requirements of GMP and develop practical strategies to apply them in the workplace.
- Managing pharmaceutical operations in a way that ensures compliance to cGMP requirements.
- Prepare a Process Control Plan using a risk assessment tool and audit their processes for GMP compliance.
- Develop strategies for GMP upgrades.
- Be able to respond to cGMP licensing audit reports.
- Working within the company's HR system, develop staff GMP training.
- State the specific requirements for the manufacture of Active Pharmaceutical Ingredients.
- State the specific requirements for the manufacture of Biotechnology products.
Content
This subject consists of 6 modules or topics:
#1 Risk Assessment, HACCP & Process Control Plans
- How Hazard Analysis and Critical Control Points (HACCP) techniques can be used to map the controls over processes.
- Principles are reinforced using case studies.
- Students should be able to effectively prepare a HACCP plan for a selected process upon completion of this module.
#2 GMP Principles for Manufacturing Operations
- Materials Management
- Manufacturing controls
- cGMP requirements for inward goods QC & sampling, dispensary controls, room clearances, yield and reconciliation, identification and traceability, status labeling
- Equipment management
#3 GMP Principles for Packaging Operations
- Packaging controls.
- Requirements to minimize possibility of mislabeling or incorrect packaging of products.
- cGMP requirements for line clearances, preprinted matter control, yield and reconciliation.
#4 GMP Responsibilities for Managers and Supervisors
- Role & responsibility of the line supervisor in a pharmaceutical manufacturing environment, concepts & practical information on how supervisors can influence & improve GMP compliance at the workplace.
- The importance of systematic GMP & competency based training - how to set out a cGMP compliant structured training program.
- Aspects of failure investigation and corrective and preventive action (CAPA) and some practical examples to demonstrate how to manage effective investigations and CAPA systems.
- Some practical case studies to show the importance of good problem solving techniques
#5 GMPs for Active Pharmaceutical Ingredients
- Define APIs and application of GMP to API manufacturing
- Review the ICH cGMP (Q7A) for Active Pharmaceutical Ingredients (APIs) including:
- Material Management
- Production and In-process controls
- Rejection and Re-use of materials
- Agents, Brokers and Re-packers
- Review of GMP requirements for APIs for use in Clinical Trials
- Review of API GMP Citations and Warning Letters
#6 GMPs for Biotechnology
- Review of the cGMPs for Biotechnology Products
- Describe GMP application to process stages.
- State Master and Working Cell Bank requirements.
- Explain GMP as applied to Purification Stages - Chromatography.
Format
The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.