Process Validation in Biopharmaceutical Production

Short description

Process validation is the method to demonstrate that a pharmaceutical process is suitable to effectively and reproducibly produce a medicinal product of consistent quality.

Process Validation can be complicated, for instance in biopharmaceuticals many different process parameters affect the production process and different aspects should be part of the validation. Furthermore, biotechnological processes are prone to variability due to raw materials, the inherent variability of bioprocesses and the variability in test results.

In the last years the whole concept of process validation also dramatically changed:  the life-cycle approach was introduced and different new regulations have been issued.

This comprehensive, practical training will clarify the whole landscape of process validation and give tools on process validation in biopharmaceutical production.  During the training, the participants will be able to practice the theory using real biotech production equipment.

Among others the following topics will be discussed:

(Changing) Regulations

• EU Annex 15 Qualification and Validation
• FDA Guidance for Industry - Process Validation: General Principles and Practices
• EMA Guideline on process validation for finished products - information and data to be provided in regulatory submissions
• Draft EMA Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
• Life-cycle approach
• ICH Q8, Q9, Q10 en Q11
• What different process validations should be performed in biopharmaceutical production?
• How can risk assessments being used as a successful tool in process validation?

Validation Process

• How to define Critical Quality Attributes (CQA’s) and Critical Process Parameters (CPP)?
• Which documents should be present for process validation (e.g. VMP, protocol, reports)?
• How to define suitable acceptance criteria?
• How many runs should be performed for a successful validation?

Control Strategy and Performance Monitoring

• How to set up a control strategy for your process?
• How can statistics help you to control your process?
• What is process capability?  Why is this relevant for your process?
• How to implement process monitoring?
• When can you reduce the amount of (in process) testing?

Media Simulations / Blank Runs

• How to set up a media simulations year plan?
• What are critical factors for performing media simulations?

Cleaning Validation

• What are critical parameters for the cleaning steps?
• How to determine the worst case soil and sample locations?
• What are acceptable analytical techniques to be used during cleaning validation?
• How to perform a recovery study?
• How to set acceptance criteria for cleaning validation?

Clearance/Elimination Validation

• What are the critical aspects for performing clearance studies?
• How to simulate the unit operation for performing a clearance validation? For instance by performing spike studies.

Extractables and Leachables

• What is the difference between extractables and leachables?
• How to perform a risk assessment for disposable materials? What is the benefit of such a risk assessment?
• How to test extractables/leachables?
• How to set appropriate acceptance criteria for leachables?

Objectives

• Understanding the different aspects critical for design and performance of process validations
• Understanding the regulatory expectations regarding process validations
• Setting up and organising different types of process validations
• Writing validation protocols and reports

Target group

• Production, QC , QA and RA persons working at a biopharmaceutical company.
• Personnel working in validation related functions.
• Personnel working in a (virtual) company outsourcing production activities.
• Reviews from participants: "The course gives you more background on how your process is structured". "Very instructive and fits in well with our daily work".