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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Full Text Here
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.
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.”
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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 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.
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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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