Since the Q8, Q9, and keep 10 guidance is were made final experiences implementing the guidance is in the ICH regions are given rise to requests for clarification. So the FDA has consolidated these requests into a structured questions and answers document that users should interrogate.
Q8 is associated with pharmaceutical development, Q9 is associated with quality risk management, and Q 10 is associated with pharmaceutical quality systems.
Posted in manufacturing
Tagged ICH, pharmaceutical, Q10, Q8, Q9, Quality, Risk Management
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This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.
The benefits of harmonizing technical requirements across the ICH regions can only be reached if the various Q-ICH guidelines are implemented and interpreted in a consistent way across the three regions. Implementation Working Group is tasked to develop Q&As to facilitate implementation of existing guidelines.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.
The benefits of harmonizing technical requirements across the ICH regions can be realized only if the various quality ICH guidances are implemented and interpreted in a consistent way across the three regions. The Q-IWG is tasked to develop Q&As to facilitate implementation of existing quality guidance.
Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
Q9 Quality Risk Management
Q10 Pharmaceutical Quality Systems
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in manufacturing
Tagged ICH, pharmaceutical development, Q10, Q8, Q9, Quality Data, Quality Risk Management
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The Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9 Quality Risk Management) to the development of a product and its manufacturing process. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle4 of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in St. Louis, Missouri from October 24-29, 2009. The main achievements are outlined below.
This meeting was highlighted by progress made in the area of safety of pharmaceutical products. The S9 Guideline, “Non-clinical Evaluation of Anticancer Pharmaceuticals”
reached Step 4. This Guideline addresses non-clinical data requirements for pharmaceutical products intended to treat cancer in patients with late stage or advanced disease. The guideline aims to accelerate development and availability of drugs for these patients with unmet medical need while safeguarding patients’ safety. In addition, the S6 Guideline, “Revision of Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals” reached Step 2. This Guideline outlines a reduced duration and number of studies involving animals and could have a major impact on the use of animals in safety testing of pharmaceutical products. ICH remains committed to the “3 R’s” agenda, which is reducing/refining/replacing animal testing in the drafting of new or revision of existing guidelines.
In addition, ICH Safety experts participated in a one day “Safety Brainstorming Session” to discuss any current gaps in ICH safety guidelines and identified several potential new topics.
There was major progress in the harmonization of pharmacopoeial texts in the three regions which will reduce testing requirements in the three regions. Three Annexes to the Q4B Guideline (Annex 7: Dissolution, Annex 9: Tablet Friability, and Annex 10: Polyacrylamide Gel Electrophoresis) reached Step 4 and another two (Annex 11: Capillary Electrophoresis and Annex 12: Analytical Sieving) reached Step 2. The ICH Quality Implementation Working Group is developing a training program for workshops that will be held in the three ICH regions that will cover the ICH Guidelines Q8, Q9 and Q10 with the aim of achieving globally consistent implementation of ICH
Guidelines Q8, Q9 and Q10. This training will consist of case studies representing the four phases of the life cycle of a pharmaceutical product. The workshops will be held in Brussels in June 2010, in Washington, D.C. in October 2010 and in Tokyo in November 2010.
The ICH gene therapy experts met to begin work on the 1st ICH Guideline on “Viral and Gene Therapy Vector Shedding and Transmission”.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
The FDA has produced a revised version of the Q8 pharmaceutical development guidance. This guidance is a revision of the ICH Q8 pharmaceutical development guidelines were published in May 2006.the Q8 guidance describes the suggested contents for the 3.2 .P .2 (pharmaceutical development) section of the regulatory submission in the ICH M4 common technical document (CTD) format.
The pharmaceutical development section provides an opportunity present the knowledge gained with application of scientific approaches and quality and risk management of the development of a product and its manufacturing process. This documentation is first produced for the original marketing application and can be updated to support new knowledge gained of the life-cycle of a product. the pharmaceutical development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviews and inspectors. The guidance also indicate areas where the demonstration of greater understanding the pharmaceutical Manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicted on level relevant scientific knowledge provided.
This guidance does not apply to contents of submissions of the drug product during the clinical research stages of drug development. However, the principles in this guidance are important to consider during all stages as well. This guidance might also be appropriate for the types of products.
The guidance goes through each of the sections in turn and describes the relevant content the regulators expect to see in that section:
The guidance is so specific as to render any summary redundant readers are directed to download the entire document by clicking this link.
The bulk of changes to the document and incorporated in an annexe at the back of the guidance, this annex provides further clarification of key concepts outlined in Q8 pharmaceutical development. In addition, this annex describes the principles of quality by design. The annex is not intended to establish new standards or to introduce new regulatory requirements; however, it shows how concepts and tools outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.
this annex suggests strategic and quality systems that a company can adopt at the very start of the drug discovery programme, it describes approaches to pharmaceutical development, that the FDA and the International commission on harmonisation (ICH) would recommend for any company developing a pharmaceutical product with a significant commitment to quality. The guidance goes on to describe a number of elements that should be included at a minimum:
Each of these strategies in elements and described in some detail, the FDA go to great pains to point out that this is not a regulatory framework, better recommended system that they believe will ensure increased quality. I believe this documentation to be of such critical nature is to be recommended reading for anybody working in the area of drug development of discovery.
Please expect a more detailed review to this document to be published on this site.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Posted in clinical, regulatory
Tagged CTD, Drug Development Strategy, eCTD, FDA, Q8, quality by design.
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