Pharmaceutical Quality Management
Definitions and scope of quality systems in pharmaceuticals has evolved over a period of time. The “Thalidomide babies tragedy” prompted the concept of continuous or cGMP. With cGMP came into existence the concept of Quality Assurance or “Zero defect”. QA advocated that quality cannot be created at the end of processing, but has to be in-built into a product at every step of manufacturing process.
Further improvements in quality systems throughout the 1990’s and beyond brought about concepts of internal audits, documentation and validations. Y2K improved quality systems further...introduced 21CFR part 11 compliance measures. Year 2010 and beyond promises further refinement in quality systems- Quality-by-Design (QbD).
What is quality by design?
Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.
Where to implement quality by design?
Quality by design implementation targets the following departments within a pharmaceutical company-Management, Procurement, R&D, Manufacturing, Testing, Quality control, Quality assurance, Regulatory, Logistics, Sales, Warehouse/ Supply chain including vendors facilities, CRO and CMO.
Principles of quality by design?
QbD scope assume that problems can be anticipated and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes and by keeping abreast of changes in scientific developments and regulatory requirements. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily
operational decisions. When fully developed and effectively managed, a QbD system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer.
Framework of quality by design?
Quality by design integrates quality systems and risk management approaches into its existing programs with the goal of providing the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product’s life cycle), continual improvement and risk management in the drug manufacturing process and also for post development changes and optimization.
Quality risk management (governed by CAPA- corrective actions preventive actions) is a valuable component of an effective quality systems framework. Quality risk management can, for example, help guide the setting of
specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigations and corrective actions.
CAPA focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. QbD system models discuss CAPA as three separate concepts, all of which are used in this guidance:
1. Remedial correction of an identified problem.
2. Root cause analysis with corrective actions to help understand the cause of the deviation and potentially prevent recurrence of a similar problem.
3. Preventive action to avert recurrence of a similar problem.
Review outcomes typically include:
• Improvements to the quality system and related quality processes.
• Improvements to manufacturing processes and products.
• Realignment of resources.
The results of a management review would typically be recorded. Planned actions should be implemented using effective CAPA and change control procedures.
To be continued...