FDA Expectations for Biopharmaceutical/Biologic API Process Validation

Industry field:

Biopharmaceutical industry

Course description:

With the issuance of the new FDA Guidance on Process Validation, firms involved in biopharmaceutical/biologic manufacturing are more likely than ever to face heightened regulatory scrutiny of their Process Validation Program.  Firms with new products in development as well as those with approved products will be expected to understand and/or incorporate the concepts of Quality by Design (QbD) and have documented and defendable process control strategy.  The instructor relies upon more than 20 years of experience in this complicated area of regulatory compliance.  The course reviews and interprets the current regulatory requirements and FDA expectations through data driven examples, actual Process Validation documentation, and discussion/interpretation of current industry trends.

Historically, biopharmaceuticals/biologics products have always faced special requirements in the validation of their processes.  FDA and other regulatory agencies have long been aware of the extent to which the “process defines the product” in this field.  Given the newly approved FDA Process Validation guidance, firms must have in place a Process Validation Program that is based upon a defendable approach that incorporates the concepts of quality systems and risk management during all stages of development and throughout the product lifecycle.  Special emphasis is given to parameter selection and evaluation, including determination of criticality and setting of valid ranges/limits.  Critical elements of specific studies required for biopharmaceuticals/biologics will be reviewed, such as chromatography resin lifetime.

Who should attend:

Personnel in Development, Manufacturing, Validation, QA, and QC who are responsible for auditing and/or involvement in key elements of the Process Validation Program should attend. Course assumes the attendee has a basic understanding of the GMP regulations.

Learning objectives:

This course is designed to provide a basic overview of biopharmaceutical/ biologic Process Validation issues and compliance requirements applicable at all stages of product development, in line with the new FDA Process Validation guidance.  Attendees will gain understanding of regulators’ concerns and expectations, the importance of a data driven program, and the most important elements to be included in a Process Validation Program.

Course outline:

Introduction: Regulatory Requirements and Compliance Overview

• Regulatory Documents

• Definitions

• Compliance Philosophy

• Product Development

• Types of Validation

• Process Validation Program Documentation

     -  Process Validation Master Plan

     -  Conformance Lots

     -  Development Report(s)

     -  Step Reports for each Unit Operation

     -  Process Change History

     -  Formulation Development

     -  Analytical Methods History

     -  Process Validation Support Studies

• Process Validation and Product Approval

Process Validation Support Studies

• Genetic Stability

• API & In-Process Impurity Profile

     -  DNA and Host-Cell Protein Removal

     -  Clearance of Process Additives

• Viral Clearance/Inactivation

• Process Pool Hold Time Studies

• Buffer Hold Studies

• Chromatography Cleaning, Storage & Reuse Studies

• Membrane Cleaning, Storage & Reuse Studies

• Final Filter Validation

• Final Bulk Container Validation

• Material Evaluation

Case Study: Pool Hold Studies

Evaluating Process Parameters

• Quality by Design

• Capturing Data

     -  Databases

     -  Initial Evaluations

• Determining Critical Parameters

• Use of Risk Assessments

• Setting Ranges

• Process Characterization

• Design Space

Case Study: Evaluating Parameters for Purification

Class Exercise: Evaluating Parameters for Fermentation

Quality by Design: Lab Bench to Market Production

• Introduction

• Considerations for Process Development

     -  Compliance in Process Development Labs

     -  Process Validation Documents

          -  Protocols

          -  Reports

     -  Raw Material Issues

     -  Scale-up Issues

• Considerations for Analytical Laboratories

     -  General Considerations

     -  Testing to Support Process Development

     -  Testing to Support Clinical Manufacturing

     -  Assay Qualification/Validation

• Tolerances and Uncertainties

• Technology Transfer

• Quality Assurance Involvement

     -  General

     -  Process Development

     -  Testing During Development

Course facts

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