Lyophilization: Validation and regulatory approaches

[Adam Fleming]

Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.

Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.

Lyophilization is considered complex

Parenteral products such as anti-infective drugs, many biotechnological products and in-vitro diagnostic products are some of the areas in which lyophilization is used. However, no matter for which field lyophilization is used, it is considered rather tough.

This is mainly because the process of obtaining the product from the lyophilization process is rather complex. It has to be carried out through a number of minute and delicate processes. Complex technology goes into the entire process.

Solution formulation, filling up vials and the validation of this process, sterilization, engineering, and the act of scaling up of the lyophilization cycle and its validation are some of the issues that make lyophilization difficult. Moreover, the processing and handling time needed for lyophilization is pretty high, as is the cost and complexity of the machinery and equipment needed for lyophilization.

Regulatory issues as well

On top of all these, the process of lyophilization has to be compliant with FDA compliance requirements. This adds to the complexity of lyophilization. However, despite these difficulties associated in many ways, lyophilization is a process that cannot be done away with, since it has tangible benefits for parenteral products.

Is there a way out of this difficulty? Should the complexity associated with lyophilization put manufacturers off? No. A webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will suggest ways of simplifying lyophilization while meeting the required regulatory expectations.

Simplified learning about the complex art of lyophilization

At this webinar, the speaker, John Godshalk, will seek to simplify the science of lyophilization. Currently a Senior Consultant at the Biologics Consulting Group; John brings the many years of his experience in the regulatory areas into this webinar. To make lyophilization simpler and to derive the benefit of this teaching, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501111?...

Understanding the FDA’s line of thinking

At this session on lyophilization, which will be highly useful for professionals such as Compliance Managers, Process Engineers, Validation Managers, Validation Engineers and Regulatory Managers; John will explain the way the FDA thinks when it comes to inspection and regulation of the lyophilization process, equipment, and controls.

The speaker will offer insights into what the FDA and other regulatory bodies consider as important while inspecting lyophilizers, and in the validation process. He will devote a major portion of the presentation to the regulatory aspects of lyophilization.

While explaining the science and art of developing lyophilization cycles and the way in which lyophilizers work and are controlled; John will take up other important areas of lyophilization, such as lyophilization controls, of which computer controls and validation are a part, and quality-related aspects of lyophilization, such as how to obtain a resulting quality product.

During the course of the presentation, the speaker will cover the following areas:

o  Science of Lyophilization

o  Cycle development and tools

o  Validation of the Lyo Cycle

o  Lyo equipment validation

o  Regulatory requirements

o  How the lyo process and equipment are inspected

o  The science and the art

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm