The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an organization that brings together pharmaceutical regulatory authorities in Europe, Japan, and the United States towards the goal of standardizing processes for safe and effective drug discovery and development. On October 10^th, 2014, ICH published an initial concept paper for guidance in its Quality category titled ”Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The resulting ICH Q12 guideline, due to be available in 2017, will complement existing quality assurance plan guidance in the pharmaceutical development and launch phases with regulatory recommendations in the later chemistry manufacturing and controls (CMC) phase. Adoption of ICH Q12 will benefit patients, pharmaceutical/ biotech companies, and regulators through continual improvement of post approval processes. So what should you do?

In this article, we will review the concept paper as well as to begin to highlight how the 3DEXPERIENCE Platform and the Licensed to Cure for BioPharma industry solution experience can help you prepare for, and implement the ICH Q12 guidance. We will follow the ICH Q12 updates closely on the blog, see all posts tagged with ICH here.

Representation of the solution (example).

While ICH Q12 is a very fitting addition to the organization’s Quality guidelines, the concept paper makes it clear that creation of the guideline is due to unforeseen gaps in the implementation of  ICH Q8-Q11, which are as follows:

• Q8 Pharmaceutical Development (PDF)
• Q9 Quality Risk Management (PDF)
• Q10 Pharmaceutical Quality System (PDF)
• Q11 Development and Manufacture of Drug Substances (PDF)

 

The ICH Q12 guideline is expected to impact the following areas

• Regulatory Dossier
  • Updates aimed at improving post approval changes
• Pharmaceutical Quality System (ICH Q10)
  • Develop improved knowledge and change management systems
• Post-approval Change Management Plans and Protocols
  • Establish criteria for managing and submitting post-approval changes

 

The benefits of ICH Q12 implementation include

• Improving reliability of the supply of pharmaceuticals through more CMC change management processes
• More standardized and useful regulatory dossiers
• Enhance use of regulatory tools for Post-approval Change Management (PACM)
• Continual improvement of the manufacturing process
• Reduction of product variability
• Increased manufacturing efficiency

 

The benefits of product lifecycle management

At Dassault Systèmes (3DS), we have long recognized the benefits of product lifecycle management in improving the drug manufacturing process and ultimately the patient experience. The Licensed to Cure for BioPharma industry solution experience powered by the 3DEXPERIENCE platform combines advances in collaboration, global product development, and information intelligence to provide operational excellence. This single version of the truth, systematic  approach to drug manufacturing fits well with the ICH Q12 vision, and we look forward to working with biotech and pharma manufacturers to guide them in adapting to these changes. You can learn more about 3DS pharma and biotech solutions by attending the 3DEXPERIENCE Forum—North America, taking place November 12-14, 2014 in Las Vegas.

The ICH Q12 guideline will represent a major change as it will be applicable over the lifecycle of the product and focused on the CMC phase. An Expert Working Group (EWG) will be comprised of assessors and inspectors with expertise in quality systems and pharma manufacturing of chemical, biological, or biotechnological products. The EWG will meet in November 2014, June 2014, and November 2015, with the Adoption of Step 2 Document occurring in Q2 of 2016 and Adoption of Step 4 Document occurring Q2 2017 (see this description for details of the ICH process). Although not all regulatory authorities (such as the Food and Drug Administration, (FDA)) adopt the ICH Guidelines directly, ICH Q12 will surely impact regulatory requirements globally.