Module 8. Secondary process validation: sterile and non-sterile processes

Aims

The aim of this module is to provide the student with an understanding of the strategies adopted in the validation of secondary pharmaceutical sterile and non-sterile processes and of the pre-requisites required before process validation may be undertaken. The relationship of the current process to that used to produce the clinical trial material, the Product Development Report, the need to clearly define process boundaries, planning, execution, and report preparation will be included.

Learning outcomes

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

• understand the importance of relating the current manufacturing method to that used to produce the original clinical trial material
• understand the importance of the Product Development Report.
• identify the pre-requisites required before process validation is undertaken.
• prepare a process Validation Plan and Protocol.
• identify critical process parameters and be familiar with the Proven Acceptable Range concept.
• set appropriate Acceptance Criteria for secondary pharmaceutical processes.
• prepare a process Validation Report.
• balance the regulatory compliance requirements with cost considerations.

Tutor information

Trevor Deeks

Trevor joined Emergent Product Development UK Limited in December 2006 as Senior Director, Pre-clinical CMC and Manufacturing Development. He has 28 years of experience in pharmaceutical manufacturing, development, quality assurance and validation. Previous positions include Head of Formulation at Marion Merrell Dow (now part of Aventis), QA Manager at Boehringer Ingelheim and Regional Director of Validation and GMP Compliance at Washington Group

He is a Qualified Person under EC legislation and is a registered pharmacist. He has managed a number of large validation projects, performed many audits and mock inspections and acted as an auditor for both the WHO and UNICEF. Over the last 8 years a significant proportion of this work has focussed on the manufacture of Biologicals. During this time he has undertaken work for more than 50 companies, including most of the top 20 pharmaceutical manufacturing companies worldwide, working in Europe, the USA, Japan and the Middle East.

He has published over 30 papers in peer reviewed journals and has contributed to a number of books including the Pharmaceutical Codex and Pharmaceutical Microbiology. He is an active presenter at PDA, ISPE and Pharmaceutical Society conferences. He is a member of the PDA UK Chapter Committee and has sat on a number of PDA, BSI, CEN, ISO and European Pharmacopoeia Commission expert working groups, including the working group which wrote ISO 13408-1, Aseptic Processing of Healthcare Products – General Requirements and the EP Commission Working Party which wrote the Monograph – Methods of Preparation of Sterile Products. He is a Past Chairman of the Parenteral Society and was Editor-in-Chief of the European Journal of Parenteral Sciences from 1996-2000.