Module 10. Secondary process validation: packaging and distribution

Aims

The aims/objectives of this module are to provide the student with an understanding of:

• the qualification of filling and packaging equipment.
• the qualification of finished product storage facilities.
• the qualification of distribution systems, from the manufacturing plant to the patient.

Learning outcomes

On completion of this module the student should be able to:

• prepare qualification protocols for filling and packaging equipment.
• prepare validation protocols for a variety of packaging processes.
• understand the importance of validation of medicinal product distribution systems.

Tutor information

Mr Ian Jones, BSc

Ian is the validation manager for packaging activities in Wyth Pharmaceuticals, Newbridge, Ireland. He lectures in Pharmaceutical Technology, Pharmaceutical QA, and Pharmaceutical Validation modules in the Dublin Institute of Technology Colleges. Ian has a detailed understanding of material sciences. He has a BSc from University College Dublin and he has completed an MSc in Pharmaceutical Quality Assurance, during which he wrote his thesis on ‘the impact of particle shape on compression processes’.

Ian is a member of the Pharmachemical Ireland working group on Pharmaceutical Validation Activities where best practice validation practices within Ireland are shared and communicated amongst pharmaceutical members.

Ian has vast experience in process, cleaning, equipment, packaging process validation and shipping qualification activities. He has knowledge of integration of risk based and lean sigma approaches within a validation system. Ian has a detailed knowledge of blending, granulation, spheronisation, compression, encapsulation and blister packaging processes and is familiar with the integration of PAT within pharmaceutical processes.