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Key Characteristics Should Be Determined Before a Biologically Derived Vaccine is Administered
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.
Michael R. Goodman, compliance specialist, Compliance Insight, explains that the idea is to introduce a “fragmented”
The steps would include:
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;
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
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);
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.