How to provide Process Validation Data in a Regulatory Submission - Live Online
3/4 November 2021
Course No. 18378
Speakers
Dr. Wilhelm Schlumbohm
Dr. Norbert Skuballa
Biologische Heilmittel Heel
All times mentioned are CET.
Objectives
This Live Online Training focuses on how to compile and provide information and data from Process Validations for Drug Substances and Drug Products both of chemical and biotechnological origin. You will learn
How to prepare and process the data derived from validation runs of drug product manufacturing processes
What needs to be documented about drug substance manufacturing processes
How to manage and document post approval changes in manufacturing processes
What to consider for compiling stability data for the dossier
How to provide validation data of biotech manufacturing processes
Background
Process Validation can be defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. In general there are two options to validate a manufacturing process: a traditional approach or an enhanced approach where continuous process verification is applied. Irrespective of which approach is used the manufacturing process should be validated before the product is placed on the market. Therefore complete data have to be provided in the dossier at the time of regulatory submission. These data should cover the validation for all manufactured strengths, batch sizes, pack sizes and proposed manufacturing sites.
Guidance on process validation information to be provided in regulatory submissions is given in 2 EMA Guidelines: “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” and “Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.
Provisions of both GMP compliant manufacture and dossier requirements are laid down in FDA’s Guidance for Industry entitled “Process Validation: General Principles and Practices”.
Target Group
This Live Online Training is designed for all persons involved in the compilation of dossiers for regulatory submissions who want to become familiar with the requirements for the documentation of Process Validation data. The course will be of interest in particular for personnel from Regulatory Affairs as well as for personnel from Quality Assurance, Production and Quality Control.
Technical Requirements
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Testimonials
Seminar Programme as PDF