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Drug Regulators, EMA (EMEA), Publishes Draft Guidance on Real Time Release Testing (Parametric Release)
Filed in manufacturing, March 11, 2010, 9:22 amDrug Regulators, EMA (EMEA), Publishes Draft Guidance on Real Time Release Testing (Parametric Release).
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Medicinal products must comply with the approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the finished product, according to the approved specifications. Under certain conditions, an alternative strategy to routine testing is possible. So far this concept has been only applied to sterility testing of terminally sterilised products (parametric release). Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made possible to apply a similar release strategy to tests other then sterility, this approach has been called Real Time Release testing.
This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline replaces the previous guideline on parametric release and does not introduce new requirements, so the parametric release part on the previous guideline is retained unchanged.
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Drug Regulators, EME (EMEA), Publish Concept Paper on Revision of the Guideline on Process Validation
Filed in manufacturing, , 9:15 amDrug Regulators, EME (EMEA), Publish Concept Paper on Revision of the Guideline on Process Validation.
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This concept paper addresses the need to update the guideline on Process Validation. This guideline was originally adopted in February 2001. With the development of new ICH guidelines Q82, Q93 and Q104, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.
The current guideline does not reflect the recent regulatory developments on Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing (RTRT).
The current guideline was developed before the elaboration of the new ICH guidelines Q8 Pharmaceutical Development, Q9 Risk Management and Q10 Quality Systems. With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation. Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle. In contrast, the current note for guidance on process validation refers only to the more traditional approach of the manufacture of a number of validation batches to confirm that the process is under control. A revision to the note for guidance on process validation will bring it in line with ICH Q8, Q9 and Q10 documents and add the ‘enhanced’ approach to the current ‘traditional’ approach. The annexes of the current guideline will be included in the revised guideline. The revised guideline will also clarify to what extent ICH Q8, Q9 and Q10 should be followed when an applicant wishes to use alternative methods of process validation including continuous verification. The FDA guidance on process validation has been recently revised to take into account ICH Q8, Q9 and Q10. The revision to the note for guidance on process validation will provide a more harmonised approach.
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Drug Regulators, EMA (EMEA), Publish Consultation on Its Road Map to 2015
Filed in regulatory, March 10, 2010, 9:08 amDrug Regulators, EMA (EMEA), Publish Consultation on Its Road Map to 2015.
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The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010
European and international partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public are invited to make their views known on the Agency’s future strategic vision, set out in the document ‘The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health’. Comments should be sent using the Agency’s comments form by 30 April 2010 to mailto:roadmap@ema.europa.eu.
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Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases
Filed in biotechnology, manufacturing, March 9, 2010, 9:02 amDrug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases.
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The, FDA, are providing manufacturers of viral vaccines, with guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use.
This guidance applies to the development of viral vaccines for the prevention and treatment of infectious diseases that are regulated by the Office of Vaccines Research and Review (OVRR) of the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).
Cell substrates are cells used to produce vaccines. The scope of this guidance document is limited to cell substrates of human or animal (including insect) origin and does not cover characterization of unicellular organisms, such as bacteria or yeast. In this document, cell substrates are categorized as primary (cells, including eggs, derived directly from an animal source and that are not stored as cell banks), diploid (cells with a normal or near-normal karyotype and that are stored as cell banks prior to use in vaccine manufacture), or continuous (cells that are immortal and do not undergo senescence). This guidance also applies to the characterization and qualification of viral seeds and other biological materials (including vaccine intermediates) used in vaccine manufacture.
This guidance finalizes the draft guidance entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,” dated September 2006 (71 FR 57547). In addition, this document replaces the information pertaining to viral vaccines for the prevention and treatment of infectious diseases that we provided in the document entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993 (Ref. 1). This document also supplements the recommendations on the production of viral vaccines for the prevention and treatment of infectious diseases, provided in International Conference on Harmonization (ICH) documents Q5A and Q5D (Refs. 2 and 3, respectively). For the production of biological products not covered under this guidance, we recommend that you refer to the “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993 (Ref. 1).
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Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence
Filed in clinical, March 8, 2010, 9:01 amDrug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence
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Alcohol dependence is in general accepted as a psychiatric disorder with harmful physical, mental and social consequences and a high probability of a chronic relapsing course. It is considered a major public health problem in most Western societies. The aim of this guideline is to provide guidance on clinical studies for drugs developed for the treatment of alcohol dependence. The present document should be conceived as general guidance, and should be read in conjunction with other applicable EU and ICH guidelines.
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Twitter Weekly Updates for 2010-03-07
Filed in Uncategorized, March 7, 2010, 2:20 pm- Some projects require a huge amount of work to develop a scope! This requires a professional and flexable approach! #
- Contemplation is as powerful as action! However like all powerful flavours it needs to be used in careful moderation! #
- When you biomarker is a hormone or steroid you realy need to understand its circadian rhythm, measuring at the wrong time can ruin your data #
- an FDA orphan application, realy taxes a tree! But this weighty document will add value to you IP! #
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Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters
Filed in devices, March 6, 2010, 12:26 pmDevice Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters.
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This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices
Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and amended by 2007/47/EC. It is
supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and MHRA Directives Bulletin 3
- Guidance on the operation of the EU vigilance system in the UK . This guidance sets out the Medicines and Healthcare products Regulatory Agency’s
(MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is
intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with
their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether
negligent or otherwise. An authoritative statement could be given only by the courts.
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Drug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.
Filed in clinical, March 4, 2010, 11:22 amDrug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.
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This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs. This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.
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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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Drug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Filed in manufacturing, March 3, 2010, 11:16 amDrug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.
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This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.
Currently, FDA requires that sterile products meet certain sterility requirements before release to the market. In many cases, the requirements for batch release are fulfilled by conducting a sterility test on finished units drawn from the batch. Parametric release is defined as a sterility assurance release program where demonstrated control of the sterilization process enables a firm to use defined critical process controls, in lieu of the sterility test, to fulfill the intent of 21 CFR 211.165(a), and 211.167(a).5 Under this strategy, market release of terminally sterilized products can be based upon meeting the defined sterilization parameters and not on performing an approved sterility test. Meeting the requirements of the parametric release process can provide greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test of finished units drawn from the batch.
This guidance does not provide information on procedures, studies, or data concerning efficacy and qualification/validation of moist heat sterilization processes. This guidance also does not provide information on sterility assurance validation programs. However, you may find information relating to such topics in the Agency’s guidance for industry on Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Current Good Manufacturing Practices (CGMP) requirements for process validation are found at 21 CFR 211.100 and, for sterile products in particular, at 21 CFR 211.113(b). Adherence to CGMPs is required for all marketed products.
The principles in the guidance may also be applicable to products sterilized by other terminal sterilization processes, such as radiation sterilization, which may be suitable for parametric release. For these types of applications, we recommend the applicant discuss with the review division whether applying the guidance would be appropriate.
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Drug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials
Filed in biotechnology, clinical, March 2, 2010, 11:10 amDrug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials
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This guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with our interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies can be interpretable, on how to choose the NI margin, and how to analyze the results.
This guidance consists of four parts. The first part is a general discussion of regulatory, study design, scientific, and statistical issues associated with the use of non-inferiority studies when these are used to establish the effectiveness of a new drug. The second part focuses on some of these issues in more detail, notably the quantitative analytical and statistical approaches used to determine the non-inferiority margin for use in NI studies, as well as the advantages and disadvantages of available methods. The third part addresses commonly asked questions about NI studies and provides practical advice about various approaches. The fourth part includes five examples of successful and unsuccessful efforts to define non inferiority margins and conduct NI studies.
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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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