The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints and recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging relevant to the QP, from component manufacture and supply to final product release including QP certification.
Packaging Site Visit
The courses running in Barnstaple, incorporate a site visit to a high volume Solid Dose Packing facility. This will allow participants to see how the theory can be applied in practice.
The course includes the following topics and reinforced using group exercises:
Day 1
- What is Pharmaceutical Packaging?
- Food vs Pharmaceutical Packaging
- Primary Packaging Materials
- Braille
- Primary Packaging Material Changes
- Printed Packaging Materials Labelling
- What is wrong with the Printed Cartons?
- Packing GMP
Day 2
- Printed Packaging Material Suppliers - ISO 9001/ISO 15378/ PS9000
- Sampling of Packaging Materials
- Using ISO 2859 Tables
- Artwork Origination and Control
- Child Resistance & Tamper Evidence
- Falsified Medicines Directive and Supply Chain Security
- Controlled Drugs
- Parallel Trade Repacking
- QP Situations in Packing Part 1
Day 3
- Line Clearance
- Packing Validation
- Packing of Clinical Trials Materials
- Start up and In-Process Controls
- Finished Product Batch Release
- QP Situations on Packing Part 2
Prerequisites
Packaging supervisors/managers, quality personnel working in packing departments, packaging technologists and engineers supporting packing operations
Teaching provider
- Tel: +44 (0)118 918 4000
Useful information
Venue: Department of 九州影院, Faculty of Sciences of Tunis, Tunis
Country: Tunisia
Teaching method: Class/lab
Duration: 3 days
Cost: £2450.00 Plus VAT
Language: English