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Premium member Presentation Transcript ICH – Q Guidelines: ICH – Q GuidelinesICH Guidelines: ICH Guidelines ICH has developed over 45 harmonized guidelines The ICH Topics are divided into four major categories: Quality (Q), i.e., those relating to chemical and pharmaceutical Quality Assurance Safety (S), i.e., those relating to in vitro and in vivo preclinical studies Efficacy (E), i.e., those relating to clinical studies in human subject Multidisciplinary topics (M), i.e., cross-cutting Topics which do not fit uniquely into one of the above categoriesWhat is ICH: What is ICH Stands for International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use”. ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines. Harmonization process – founded April 1990Members of ICH: Members of ICH ICH is comprised of representatives from the six cosponsoring parties as well as three Observers and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA): JAPAN: the Ministry of Health & Welfare (MHW) and the Japan Pharmaceutical Manufacturers Association (JPMA) EU: the European Commission (EC) and the European Federation of Pharmaceutical Industries’ Associations (EFPIA) USA: the Food & Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Observers: WHO, EFTA, and CanadaICH Q Documents: ICH Q Documents Q1 Stability Q2 Analytical Validation Q3 Impurities Q4 Pharmacopoeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality SystemsICH Q1A Stability Testing for New Drug Substances and Products: ICH Q1A Stability Testing for New Drug Substances and Products Developed with in the Expert Working Group of ICH Stability testing requirement for a Registration Application within Tripartite Objective is to provide evidence of how the quality of a drug substance or drug product varies with time under variety of environmental forces (temp., humidity, light) and enables recommended storage conditions, re-test periods and shelf lives to be establishedICH Q2 (R1) Validation of Analytical Procedures : Text and Methodology: ICH Q2 (R1) Validation of Analytical Procedures : Text and Methodology Demonstrate that it is suitable for its intended purpose. Four most common types of analytical procedures: Identification tests Quantitative tests for impurities' content Limit tests for the control of impurities Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug productICH Q3A Impurities in New Drug Substances : ICH Q3A Impurities in New Drug Substances provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. Impurities in new drug substances are addressed from two perspectives: Chemistry aspects include classification and identification of impurities, report generation, listing of impurities in specifications, and a brief discussion of analytical procedures Safety aspects include specific guidance for qualifying those impurities that were not present, or were present at substantially lower levels, in batches of a new drug substance used in safety and clinical studies. Second revision of the Q3A guidance, which was published in 1996 and revised in 2003. Impurities can be classified into the following categories: Organic impurities (process- and drug-related) Inorganic impurities Residual solventsICH Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) : ICH Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Pharmacopeial Discussion Group (PDG) comprised of representatives of the United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP), and the European Pharmacopoeia (Ph.Eur. or EP) Activity of Q4B are as follows: Effective way to raise and resolve issues that might impact both industry and regulators. For FDA, interchangeability means the possible use of the harmonized methods of JP and EP, where deemed appropriate and based on our scientific review, to be considered as equivalent to the USP method. A savings in time and effort: Given the unified approach and strength of working directly with the three regulatory regions, it is an effective way to partner in the pharmacopeial process to effect change, where single, independent efforts might not be as successful. Maintains FDA's review authority In case of any question, the local regional method prevails. Establishes a process for multi-center input into scientific review for determining the interchangeabilityICH Q 5 C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products: ICH Q 5 C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Applies to well-characterised proteins and Polypeptides,their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. Covers the generation and submission of stability data for all biotechnological products (vaccines, growth hormones, etc.) The document does not cover antibiotics, allergenic extracts, heparins, vitamins or whole blood. Purpose: Guidance to applicants regarding the type of stability studies that should be provided in support of marketing applications.ICH Q6A Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances : ICH Q6A Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been registered previously in the United States, the European Union, or Japan "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Addresses only marketing approval of new drug products and substances but not during the CT developmentICH-Q7A Guidance for Active Pharmaceutical Ingredients: ICH-Q7A Guidance for Active Pharmaceutical Ingredients Provide guidance regarding GMP for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality Define manufacturing operations to include Receipt of material Production Packaging and Repackaging Quality control Labeling and Re-labeling Release Storage Distribution of APIs and related controls Vaccines are not included Should not use a stand-alone section Covers cell culture, fermentation (CCF), tissue or animal sources including transgenic animalsICH – Q8(R1) Pharmaceutical Development: ICH – Q8(R1) Pharmaceutical Development Pharmaceutical development should include the following elements: Defining the target product profile as it related Q,S and E Identifying Critical Quality Attributes (CQA) of the drug product to study and control the product quality. Determining the quality attributes of the drug substance and Excipients, etc to get desired quality. Selecting an appropriate manufacturing process and a control strategy. Q8(R2) Pharmaceutical Development : Q8(R2) Pharmaceutical Development Describes science and risk-based approaches for pharmaceutical product and manufacturing process Development to consistently deliver the intended performance of the product Introduced concepts of design space and flexible regulatory approaches Scientific understanding to support the establishment of design space, specifications and manufacturing controls Introduced concepts of Quality by Design (QbD) and provided examples of QbD development approaches and design spaceICH-Q9 Quality Risk Management: ICH-Q9 Quality Risk Management Describes systematic processes for the assessment, control, communication and review of quality risks Applies over product lifecycle: development, manufacturing and distribution Includes principles, methodologies and examples of tools for quality risk management Assessment of risk to quality should: - Be based on scientific knowledge - Link to the protection of the patient - Extend over the lifecycle of the product Risk: Combination of the probability of occurrence of harm and severity of that harm.ICH-Q10 Pharmaceutical Quality System : ICH-Q10 Pharmaceutical Quality System Incorporates the concepts behind Q8 and Q9 by providing a pharmaceutical quality system that can be implemented through out the product life cycle. Facilitates continual improvement and strengthen the link between Q8 and Q9. Quality attributes to meet patients need. Establish and maintain State of Control (Process performance and Product quality). - Track and trend product quality - Maintain and update models as needed - Internally verify that process changes are successful Good scientific development (Q8) in combination with QRM (Q9) and PQS (Q10) will improve drug quality and efficiency of pharmaceutical manufacturingICH-Q11 Development and Manufacture of Drug Substances: ICH-Q11 Development and Manufacture of Drug Substances High level technical guidance relevant to the design, development and manufacture of drug substances as a part of total strategy. Provide guidance for drug substances (Q6A & Q6B) Identify similarities and differences of biologics and chemical entities. Facilitate regulatory evaluation process To demonstrate process and product understanding Address the complexity of different manufacturing process & product Outline science based concepts Address systematic and enhances approaches for design space, control strategies and real-time releaseThank you…: Thank you… You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.