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What’s New with cGMP?


Good Manufacturing Practices (GMP) modernization and harmonization initiatives continue to evolve as the pharmaceutical industry and regulatory agencies work together to develop more effective methods of process control using science-based decision making. Quality risk management and knowledge management practices have aligned with an emphasis on pharmaceutical quality systems. This evolving framework, known in the industry as Quality by Design (QbD), encompasses product and process understanding that evolves throughout a pharmaceutical product’s lifecycle. Recommendations for drug product development, manufacturing and continuous improvement are captured in the International Conference on Harmonization (ICH) technical guidelines:

  • Q8 Pharmaceutical Development
  • Q9 Quality Risk Management
  • Q10 Pharmaceutical Quality Systems

The model is built on the development of Quality Target Product Profiles for each drug product, which ties lifecycle stage goals and quality elements to patient safety. Properties of a container closure system (CCS) are among the attributes of a drug product quality target product profile that should be considered. (1)

According to ICH Q8, the drug development summary should highlight the evolution of the formulation design from initial concept to final design and take into consideration the choice of drug product components. Materials selected for primary packaging should be justified and controlled. (2) CCS attributes include physical, functional and chemical characteristics that can pose risks to drug product potency, such as degradation, changes in pH, absorption/adsorption, precipitation, discoloration and purity. (3) CCS knowledge is needed for each lifecycle stage, and the parenteral route of administration requires in-depth studies to assure suitability for use. Science-based decision making includes the quality aspects relative to four stage goals outlined in ICH Q10: i) Pharmaceutical Development, ii) Technology Transfer, iii) Commercial Manufacturing, and iv) Product Discontinuation. In each stage, factors for consideration are intended to promote the lifecycle approach to product quality relative to four major elements. (4)

  • Process performance and product quality monitoring system
  • Corrective action and preventive action (CAPA) system
  • Change management system
  • Management review of process performance and product quality

This model can be applied to all elements of a drug manufacturing process, including CCS components.  Since achievement of a product with quality attributes appropriate to meet the needs of patients, health care professionals and regulatory authorities is the ultimate goal, the supplier quality system is key to assuring product realization. (5) CCS suppliers can play a significant role in meeting this objective and lend transparency with proper communication and planning. They can help ensure regulatory compliance as well as facilitate continual improvement with components and pharmaceutical products. The component manufacturer is responsible for component design, while the drug sponsor is responsible for the determining the components’ suitability for intended use. This results in consideration of multiple independent manufacturing processes that must collaborate to be mutually beneficial to the quality of the drug product and ultimately patient safety. Product knowledge, risk review and communication can build necessary alliances between pharma suppliers, leading to a more transparent process.

To discuss how the ICH guidelines affect your manufacturing process, contact your West account manager today.

  Q8 Development
At a minimum those aspects…of container closure systems and manufacturing processes that are critical to product quality should be determined and control strategies justified

Q9 Risk
The level of effort, formality and documentation of the Quality Risk Management process should be commensurate with the level of risk

Pharmaceutical Development

Technology Transfer

Commercial Manufacturing


Knowledge throughout development can be used to establish a control strategy

Knowledge obtained during transfer and scale-up activities can be useful in further developing a control strategy

A well-defined system for monitoring should be applied to assure performance within a state of control and identify areas for improvement

Once manufacturing ceases, monitoring such as stability studies should continue to completion

Q10 Risk
Lifecycle stage goals 

Excerpts from the ICH Guidance Documents – Q8, Q9 and Q10

  1. Guidance for Industry: Q8 (R2) Pharmaceutical Development Revision 2, US Department of Health and Human Services Food and Drug Administration, CDER/CBER, ICH November, 2009.
  2. Guidance for Industry: Q9 Risk Management, US Department of Health and Human Services Food and Drug Administration CDER/CBER, ICH June 2006.
  3. Guidance for Industry: Q10 Pharmaceutical Quality System, US Department of Health and Human Services Food and Drug Administration, CDER/CBER, ICH April, 2009.
  4. Guidance for Industry - Container Closure Systems for Packaging Human Drugs and Biologics – Chemistry, Manufacturing, and Controls Documentation. US Department of Health and Human Services Food and Drug Administration, CDER, CBER April, 1999 Guidances/UCM070551.pdf
  5. Markovic I., Evaluation of Safety and Quality Impact of Extractables and Leachables in Therapeutic Biologic Protein Products: A Risked Based Perspective, Expert Opinion Drug Safety,  487-91, September 2007