Engineering & Quality: Quality Guidelines
ISPE & FDA to collaborate on Q8, Q9 implementation
by Gil Roth
The International Society for Pharmaceutical Engineering (ISPE) recently announced that it is collaborating with FDA to help implement the new Q8 and Q9 quality guidelines developed by the International Conference on Harmonization (ICH). ISPE has scheduled a workshop in June — which will include FDA participation — to discuss the issues and gain industry input on the initiative. The session will be held the June 6-7 2007 in Alexandria, Virginia, in conjunction with the ISPE Washington Conference (June 4-7). We spoke with ISPE president and chief executive officer Bob Best about the guidelines and ISPE’s involvement in the process. For more information: www.ispe.org.
Contract Pharma: What is the status of ISPE's collaboration with FDA on implementing the Q8 and Q9 quality guidelines?
Bob Best: The ICH quality guidelines on Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management) are inter-nationally harmonized guidelines within the three ICH Regions: U.S., Europe, and Japan. These guidelines are typically very high level and do not provide in any great detail what requisite information and data should be submitted to regulatory agencies for approval. The ICH guidelines help define what the important aspects in pharmaceutical drug development are and how risk management tools can help reduce risk and ultimately obtain more robust manufacturing processes. This, coupled with modern quality systems, is expected to improve product quality. Obviously, filling the knowledge gap between what the ICH guidelines are and what firms need to file would be of great benefit to the industry and the regulators.
FDA has agreed to collaborate with ISPE in the development of implementation documents. We have met with FDA representatives and developed a path forward. We also hope to obtain input from European regulatory agencies to ensure that harmonization is maintained.
We in ISPE have set up teams to identify the gaps in knowledge and will be populating these teams with subject matter experts to develop implementation documents, in collaboration with FDA. This will be an ongoing initiative with a horizon of three-plus years.
FDA and ISPE have agreed to hold a co-sponsored workshop in Washington in June where we can get additional valuable input from other stakeholders as to what recommendations should be provided in these implementation documents.
We recognize that the issues dealt with by Q8 and Q9 are global issues, requiring global solutions. We will work with the industry and regulators worldwide to develop suitable implementation documents.
CP: How are the new guidelines expected to improve manufacturing quality?
BB: The ICH guidelines encourage the application of Quality by Design principles in the development and manufacture of both NCEs and biotech drug products. The quality of the manufacturing processes will be enhanced through the identification and scientific understanding of the critical manufacturing process controls and the critical attributes of the drug. By working with the industry and other stakeholders, the implementation will be better understood.
CP: What major international differences do Q8 and Q9 address and attempt to harmonize?
BB: The areas of drug development and of risk management are very complex processes. Many conferences were devoted seeking answers to these issues. The ICH Expert Working Groups from the three regions met, discussed the pertinent issues and produced Q8 and Q9, which represent the harmonized expectation of the three Regions. This process removed many previous differences in filing requirements. Some differences remain due to regional differences in laws, approval processes, and responsibilities of the GMP investigators versus the assessors.
CP: What are the major hurdles that need to be overcome to implement Q8 and Q9?
BB: Q8 and Q9 quality guidelines are easily read, but the implementation remains a challenge. What is needed is to get information out to the stakeholders, in a consistent manner, about the intent of the Expert Working Group (EWG) in developing the guidelines. There is a need to present case studies and provide workshops to discuss and resolve these issues. To do this, we are collaborating with the members of the EWGs. It will take time to disseminate this information to all levels of the stakeholders.
We at ISPE are very mindful, as are the industry leaders, that this is a global challenge, and requires global solutions. It is very important to bring together the thinking of all regulators and industry from the three regions. ISPE continues to work with the global regulatory bodies and global industry to assure that any implementation guidance we develop will be of global value.
CP: What impact may these guidelines have on manufacturing practices at Contract Manufacturing Organizations?
BB: The impact will be the same, since Contract Manufacturing Organizations must comply with the same regulations as in-house manufacturers. However, keep in mind that guidelines are not regulations and many aspects of the ICH guidelines are stated to be optional.
We are quick to point out that guidelines are only one way to meet the requirements of regulations; they are not necessarily the only way. A firm or a Contract Manufacturer may elect to develop another equally acceptable approach to meet the regulatory requirements. However, it is generally much easier to follow the established ICH guidelines.