Quality Systems for Drugs and Biologics - Pharmaceutical Technology

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Quality Systems for Drugs and Biologics
FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.


Pharmaceutical Technology


Management should review the quality system frequently during implementation and after maturing, as a part of the general management meetings. A periodic review by a qualified outside source could be useful in determining suitability and effectiveness of the quality system. Management's review should include assessments of the process, product, and customer needs. A review should consider the following at minimum:

  • Appropriateness of the quality policy and objectives
  • Results of audits and other assessments
  • Customer feedback (including complaints)
  • Data trending analysis results
  • Preventive action to avoid serious issues or recurrence of issues
  • Follow-up action from previous management reviews
  • Changes to business practices or environment
  • Product characteristics meeting customer needs.

Review outcomes typically include improvements to the quality system and processes, improvements to manufacturing processes and products, and realignment of resources. Results should be recorded, and planned actions should be implemented using an effective corrective and preventive action and change control procedures and process.

Resources. Management must provide adequate resources for the following:
  • Supplying and maintaining facilities and equipment to Product quality product
  • Acquiring and receiving material for their intended use
  • Processing the material to produce the finished product
  • Laboratory analysis of the product
  • Collection, storage, and examination of in-process, stability, and reserve samples.

Management should be held responsible for:

  • Developing personnel to support a problem-solving and communicative organizational culture
  • Creating environment that values employee suggestions and acts on suggestions for improvement
  • Developing cross-functional groups to share ideas to improve procedures and processes
  • Defining qualifications for each quality position
  • Ensuring employees understand the impact of their activities on the product and the customers.

Training is critical to ensure all employees remain proficient in their operational functions and understanding of CGMP regulations. Training should be two-fold: covering the employees' job function, as well as CGMP regulatory requirements. Training programs should include:

  • Evaluation of training needs
  • Provision to satisfy needs
  • Evaluation of effectiveness of training
  • Documentation of training and/or retraining
  • A discussion of how skills from training should be incorporated into day-to-day performance.

Technical experts who understand pharmaceutical science, risk factors, and manufacturing processes related to the product should be responsible for specific facility and equipment requirements. It is important to note that FDA feels that the CGMP regulations require a higher standard for calibration and maintenance than most nonpharmaceutical quality-system models.

Outsourced resources used in operations must be controlled and qualified. Contracts should clearly describe the materials or service, quality specifications, responsibilities, and communication mechanisms. The quality unit is responsible for approving or rejecting products or services provided under a contract.


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