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
In order to bring FDA processes in line with ICH guidance and to harmonise technical requirements for registration of marketing approval, the FDA has published this updated guidance on the frequency of submissions and for the content of periodic safety updates. The goal is to bring all three regions (EU, Japan, United States) into harmonisation.
Posted in market access, marketing
Tagged Cliniacl safety, E2C, ICH, periodic reporting
The FDA has published this draft guidance in response to international conference on harmonisation of technical requirements for the register duration of pharmaceuticals for human use meetings and publications. This guidance is specific to the requirements of data elements and message specification.
the ICH E2B(R3) message standard is built upon health level III ICSR release free standard. Conceptually this report of information describing adverse events or reactions experienced by an individual patient; the events and reactions can be related to the administration of one or more medicinal products at a particular point in time. The ICSR can also be used exchange other information such as medication errors that do not involve adverse events or reactions.
The FDA sees the guidance as supporting the implementation of software tools for creating, editing, sending and receiving electronic IC SR messages. If you do not see it as a guide pharmacologist practices nor is it intended to explain the underlying scientific or medical issues that support the correlation categorisation or analysis of safety information.
The FDA as published in appendix to its guidance on the electronic transmission of individual case safety reports (ICRS) which is an implementation guide for international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use and to electronic message of the transmission of individual case safety reports.
The appendix is intended to assist reports and recipients in implementing the systems with a special focus on the recommendations come version back and forth between previous standards.
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This document is an appendix to the guide for implementing the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2: Electronic Message for the Transmission of Individual Case Safety Reports (ICSRs).”
This Appendix is intended to assist reporters and recipients (including pharmaceutical companies, authorities and non-commercial sponsors) in implementing systems with special focus on the recommendations for conversion back and forth between the previous standard, i.e., E2B(R2) and this new one, i.e., E2B(R3).
The evolution of the guideline, from E2B(R2) to E2B(R3), has the consequence that ICSRs cannot be perfectly converted from one standard version to the other (either backwards or forwards). This document presents the recommendations for conversion agreed within ICH so as to provide a reference to system providers, and a common understanding on the way to convert ICSRs and ICSR acknowledgments (ICSR ACKs) between E2B(R2) and E2B(R3).
Two pilot programs of collaboration on inspections between European medicines agency and its international partners in United States and Australia have been conducted successfully. The two programs focused on collaboration between international regulators for quality and safety.
Joint inspections on good clinical practice were undertaken in a large number of clinical programs, as well as joint inspections of active pharmaceutical ingredients manufacturing plants.
All agencies have agreed that the programs have been a success and will continue on this collaborative approach in future. This is clearly start of international recognition between the agencies inspection standards, which should have positive effects of mutual recognition and reduce the regulatory burden of companies operating internationally in our industry.
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Two pilot programmes of collaboration on inspections between the European Medicines Agency (EMA) and its international partners in the United States and Australia have concluded successfully, according to two reports published today. The two programmes focus on increasing international regulatory collaboration among the regulatory agencies so that drug quality and safety can be enhanced globally.
The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the joint GCP inspection pilot, the EMA and the US Food and Drug Administration (FDA) exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the EU Member States, organised 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency’s inspection procedures. It demonstrates how the agencies can work together to improve the protection of participants in clinical trials and better ensure the integrity of data submitted as the basis for drug approvals.
The report on the joint active pharmaceutical ingredients (API) inspections pilot programme details the success of information-sharing and collaboration on API inspections among the participating authorities (EMA, France, Germany, Ireland, Italy, United Kingdom, EDQM, FDA and Australia’s Therapeutic Goods Administration (TGA)). Over the course of the 24-month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine joint inspections.
Both pilots involved the exchange of considerable amounts of information and the establishment of inspections carried out jointly by the agencies. This led to increased levels of understanding between the agencies, and a greater number of inspections of value to more than one authority.
Based on the positive experience in the two pilots, the agencies have agreed to continue with their collaboration on inspections, taking into account the experiences and lessons learned during the pilot phases.
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This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.
A company can choose to follow different approaches in developing a drug substance. For the purpose of this guideline, the terms “traditional” and “enhanced” are used to differentiate two possible approaches. In a traditional approach, set points and operating ranges for process parameters are defined and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria. In an enhanced approach, risk management and more extensive scientific knowledge are used to select process parameters and unit operations that impact critical quality attributes (CQAs) for evaluation in further studies to establish any design space(s) and control strategies applicable over the lifecycle of the drug substance. As discussed in ICH Q8 for drug product, a greater understanding of the drug substance and its manufacturing process can create the basis for more flexible regulatory approaches. The degree of regulatory flexibility is generally predicated on the level of relevant scientific knowledge provided in the application for marketing authorisation.
Traditional and enhanced approaches are not mutually exclusive. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both.
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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Posted in manufacturing
Tagged biological, biotechnology, CMC, CTD, Drug, ICH, ICH Q11, NCE, Q11
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The European Medicines Agency is organising this public-awareness event to inform attendees about the electronic submission of medicinal product information in line with the provisions set out in the new pharmacovigilance legislation and the five identification of medicinal product standards under finalisation by the International Organization of Standardization. Registration open until 15/09/2011. Places limited.
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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The Parenteral Drug Association, the International Society for Pharmaceutical Engineering, the Food and Drug Administration and the European Medicines Agency are creating a special joint conference dedicated to teaching the principles of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10. This is a unique opportunity to learn these principles from companies that have implemented a pharmaceutical quality system across the product lifecycle according to the ICH Q10 model.
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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Posted in manufacturing
Tagged ICH, ICH Q10, Registration of Pharmaceuticals for Human Use
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The Parenteral Drug Association, the International Society for Pharmaceutical Engineering, the Food and Drug Administration and the European Medicines Agency are creating a special joint conference dedicated to teaching the principles of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10. This is a unique opportunity to learn these principles from companies that have implemented a pharmaceutical quality system across the product lifecycle according to the ICH Q10 model.
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.
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This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
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.
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Posted in manufacturing
Tagged 7(R2), dissolution, ICH, Q4B, Test General Chapter Annex
According to the FDA half for all medical devices used in USA are imported while 80% of active pharmaceutical ingredients sold in the US and manufactured elsewhere, and this trend is increasing.
The FDA has unveiled a new global strategy to help ensure the safety and quality of imported products and increasingly complex global supply chain..
” global production of FDA regulated goods exploded over the past 10 years. In addition to increasing import finished products, manufacturers increasingly use imported materials ingredients in a US production facilities, making the distinction between domestic and imported products obsolete” said Margaret Hamburg Commissioner of the FDA. A dramatic change in strategy must be implemented.
According to the report published by the FDA the FDA’s international operating model will rely on enhanced intelligence, information sharing, data driven risk analysis, and smart allocation of resources through partnerships.
the new approach will rest on four core building blocks:
This is another example of increasing globalisation pharmaceutical industry, regulators and no longer operating geographically distinct silos, by reaching out to each other to enforce strict adherence to ICH based regulatory perspectives. Other examples of this include joint EU FDA evaluation processes for orphan drugs, manufacturing quality, and quality by design. Where will this trend lead remains to be seen, but it is clear that everybody operating the pharmaceutical, biotechnology and medical devices industies needs to think globally.
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.
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The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of drug substance may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical parameter in the synthetic process. This guideline does not address solvents deliberately used as excipients nor does it address solvates. However, the content of solvents in such products should be evaluated and justified.
Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Some solvents that are known to cause unacceptable toxicities (Class 1, Table 1) should be avoided in the production of drug substances, excipients, or drug products unless their use can be strongly justified in a risk-benefit assessment. Some solvents associated with less severe toxicity (Class 2, Table 2) should be limited in order to protect patients from potential adverse effects. Ideally, less toxic solvents (Class 3, Table 3) should be used where practical. The complete list of solvents included in this guideline is given in Appendix 1.
The lists are not exhaustive and other solvents can be used and later added to the lists. Recommended limits of Class 1 and 2 solvents or classification of solvents may change as new safety data becomes available. Supporting safety data in a marketing application for a new drug product containing a new solvent may be based on concepts in this guideline or the concept of qualification of impurities as expressed in the guideline for drug substance (Q3A, Impurities in New Drug Substances) or drug product (Q3B, Impurities in New Drug Products), or all three 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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This annex is the result of the Q4B process for Dissolution Test.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
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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Posted in manufacturing
Tagged dissolution test, ICH, PDG, Pharmacopoeial Discussion Group, Q4B
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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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The periodic analysis of safety information is crucial to the ongoing assessment of risk to trial subjects during the clinical development of an investigational drug. It is also important to notify regulators and other interested parties (e.g. ethics committees) at regular intervals of the evolving safety profile of an investigational drug and actions proposed or being taken to address safety concerns. Currently, regulations in some countries or regions require submission of a periodic report to regulatory authorities to address these issues. However, significant differences in the content and format of these reports highlight the importance of a common standard to promote a consistent approach, and enhance efficiency. The Development Safety Update Report (DSUR) proposed in this guideline is intended to be the common standard for annual clinical trial safety reporting among the ICH regions and can be submitted instead of existing reports including the US IND Annual Report and the EU Annual Safety Report. This comprehensive, thoughtful annual review can provide an additional level of assurance of protection for subjects in clinical trials. In addition, by harmonising the format, content and timing of annual safety reports, regulators in the three ICH regions can receive the same information at the same time, thereby reducing the number of reports generated. The main objective of a DSUR is to present an annual review and evaluation of pertinent safety information collected during the reporting period to: (1) summarise the current understanding and management of identified and potential risks; (2) describe new safety issues that could have an impact on the protection of clinical trial subjects; (3) examine whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety; and (4) provide an update on the status of the clinical investigation/development programme. This guideline defines the content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.
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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The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and can therefore take the place of these existing reports.1 This guideline defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.
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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Posted in medical report, regulatory
Tagged Drug Safety Update Report, DSUR, ICH, ICH E2F
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This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.34. Bulk Density and Tapped Density of Powders, JP 3.01 Determination of Bulk and Tapped Densities, and USP General Chapter <616> Bulk Density and Tapped Density of Powders, can be used as interchangeable in the ICH regions subject to the following conditions:
For Bulk Density Method 2, the tolerance of the cup volume should be 16.39 ±0.20 milliliters (mL).
For Tapped Density Method 3, the test conditions, including tapping height, should be specified in the results.
For Measures of Powder Compressibility, if V10 is used, it should be clearly stated in the results.
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.
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Posted in manufacturing
Tagged Bulk Density, ICH, ICH Q4B, Powders, Tapped Density
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This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.38. Particle-size Distribution Estimation by Analytical Sieving, JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method, and USP General Chapter <786> Particle Size Distribution Estimation by Analytical Sieving, can be used as interchangeable in the ICH regions.
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.
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The use of biomarkers has the potential to facilitate the availability of safer and more effective drug or biotechnology products, to guide dose selection and to enhance their benefit-risk profile. This guideline is based on previous experiences with submissions containing biomarker data in the various regions. These submissions have been either stand-alone biomarker qualification applications or a component of medicinal product-related regulatory process marketing applications (NDAs / BLAs / MAAs). The development of a consistent format for submission of biomarker data will facilitate easy review and exchange of assessments between regions.
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.
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This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.2.47. Capillary Electrophoresis, JP General Information 4. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis, can be used as interchangeable in the ICH regions.
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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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