Key Characteristics Should Be Determined Before a Biologically Derived Vaccine is Administered

PRLog (Press Release) - Dec. 3, 2012 - (Fairfield, Ohio) The U.S. Food and Drug Administration (FDA), in its report titled 'Pharmaceutical Quality for the 21st Century: A Risk-Based Approach', has advocated the Quality-by-design approach of process validation for the pharmaceutical industry. The new approach would include Quality by Design - Process Development, Process Analytical Technologies, and Corrective and Preventive Actions (CAPA), reports Compliance Insight Inc., a regulatory and quality assurance consulting firm.

Michael R. Goodman, compliance specialist, Compliance Insight, explains that the idea is to introduce a “fragmented” approach to process development, focus on the importance of process development with regards to process validation, and encourage risk-mitigation through predicting potential problems from internal and external forces.

The steps would include:

Process development

Equipment qualification

Process validation supporting documentation (scientific research)

Quality-by-design - process validation lots

Process analytical technologies (PAT)

Corrective and Preventive Action

The following can be achieved with the Quality-by-design approach - mitigating potential risk, maximizing understanding of the process, and establishing in-process controls.  The purpose is to provide scientific and supporting evidence of a controlled process, and provide in-depth characterization studies in case of out-of-specification investigation, according to Goodman.

For example, the process validation prerequisites for a biologically derived pharmaceutical could include: defined raw materials; defined equipment, utilities, and services; defined process parameters and acceptance range; standard operating procedures; process documentation; critical analysis/risk-analysis; validation master plan; checks and controls for equipment, services, and utilities; validated analytical methods; qualified instruments; maintenance and calibration programs; change control program; identification of critical process and parameter markers, with their respective acceptance range; and bio-assays defined and qualified.

A proper validation would follow thereafter. The key factors to be included in the validation process would be:

Adherence to Process Development Quality by Design (QbD)

Risk Based Approach

Design of Experiments (DOE) performed for process steps

Operating Range

Purpose of Step

Variability in and out of operating range

Perform at lab scale

Evidence to be referenced in possible investigations

In simple terms, the Quality-by-design focuses on raw material (every aspect of the ingredients and material including right up to what packaging would be used; equipment (monitoring, maintenance, calibration); manufacturing processes (emphasis on the design and implementation of the most efficient manufacturing process); checks and controls (critical measures to ensure and maintain quality at every step).

For the layman, Quality-by-design would translate into better quality of drugs. It would require greater commitment and dedication to the development of drugs on the part of manufacturers. Pharmaceutical manufactures would have to focus on what potential quality risks could be and trace them back to manufacturing processes or raw materials.

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North America, Europe and Asia.

For more information visit Compliance Insight Inc.