Tag Archives: CMC

EMA Publish Guidance on ICH Q11 on Development and Manufacture of Chemical and Biotechnology Drug Substances

EMA Publish Guidance on ICH Q11 on Development and Manufacture of Chemical and Biotechnology Drug Substances.

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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.



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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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EMA Announce Meeting on Lifecycles in Pharmaceutical Manufacturing

EMA Announce Meeting on Lifecycles in Pharmaceutical Manufacturing

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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.


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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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Oxygen Healthcare (O2h) to Provide Chemistry Support to Chromocell

Oxygen Healthcare (O2h) to Provide Chemistry Support to Chromocell

Oxygen Healthcare Ltd. (O2h), a Piramal Group Company and Chromocell Corporation, an emerging life sciences company active in both flavors and therapeutics discovery, today signed an agreement under which O2h will provide supplemental chemistry support to further accelerate the drug discovery initiatives at Chromocell.

“I have known O2h for a number of years and am impressed by its delivery focus,” said David Palling, Senior Vice President, Therapeutics, Chromocell. “With the in-house chemistry resources and the faster-than-expected progress made in our therapeutic programs, complementary support from O2h will help us maximize resources and reach our end-points quicker.  I look forward to this opportunity of working with them to advance our drug discovery pipeline.”

O2h will provide Chromocell during 2011 with focused libraries of compounds at mg-g scale for various projects.

Sunil Shah, CEO, O2h said “O2h has optimized its operations for discovery speed and delivery to help accelerate drug discovery efforts of companies in the United States, Europe and Japan. It is our privilege to work with the experienced team led by Dr. Palling at Chromocell,”

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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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FDA Publish Sample Formats for CMC Sections

FDA Publish Sample Formats for CMC Sections

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These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET Steering Committee in the Center for Drug Evaluation and Research at the Food and Drug Administration. This document represents the Agency’s current thinking on the production of these positron emission tomography (PET) drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statues, regulations, or both.

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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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MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

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These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.

Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK  Competent Authority), in accordance with these Guidance Notes.

This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make 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 or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

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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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FDA Publishes Guidance on Impurities in ANDAs

FDA Publishes Guidance on Impurities in ANDAs

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This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting:
• Original abbreviated new drug applications (ANDAs)
• ANDA supplements for changes that may affect the quantitative or qualitative degradation product profile
The guidance also provides recommendations for establishing acceptance criteria for degradation products (specifically, degradation products of the active ingredient or reaction products of the active ingredient with an excipient(s) and/or immediate container/closure system) in generic drug products. The guidance will replace an existing 1998 draft guidance of the same name.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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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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EMA Publish Concept Paper on Storage Conditions During Transport

EMA Publish Concept Paper on Storage Conditions During Transport.

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The globalisation of the manufacture of human and veterinary medicinal products has brought both benefits and a wide range of challenges. This paper is concerned with challenges related to the maintenance of appropriate transit conditions during transport as products move through all stages of the manufacturing and wholesale distribution system from active substance through the wholesale distribution system to ensure that patients and animals receive safe and efficacious medicinal products. The current guidance (CPMP/QWP/609/96/Rev2) was written in 1996 and revised in 2003, during this time significant changes continued to occur in the globalisation of manufacture with a consequent increase in the complexity and vulnerability in the supply chain.

There is a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation. In order that products are fit for their intended purpose, including the ability to tolerate the range of expected storage conditions during use by patients or use in animals, simple and risk-based guidance is required for the transport. Such guidance needs to cover cold chain and non-cold chain products and all of the different stages of manufacture, importation and distribution.

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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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FDA Publishes Guidance on ANDAs and Impurities

FDA Publishes Guidance on ANDAs and Impurities

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This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting:
• Original abbreviated new drug applications (ANDAs)
• ANDA supplements for changes that may affect the quantitative or qualitative degradation product profile
The guidance also provides recommendations for establishing acceptance criteria for degradation products (specifically, degradation products of the active ingredient or reaction products of the active ingredient with an excipient(s) and/or immediate container/closure system) in generic drug products. The guidance will replace an existing 1998 draft guidance of the same name.

For Assistance with CMC Issues Click Here

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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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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EMA Publish Guidance on IV Products in Micellar Systems

EMA Publish Guidance on IV Products in Micellar Systems.

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This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type.
In particular, this text applies in the following contexts cumulatively:
• medicinal products for intravenous injection or infusion which contain active substances, which have a low aqueous solubility and which are therefore solubilised in an aqueous micellar system1, where the main objective of the development is to solubilise the drug, and not to create a system where special size- or surface-dependent properties of the disperse phase are critical factors in the kinetics and disposition of the drug.
• it is particularly relevant to ‘traditional’ or ‘established’ ‘small molecule, non-polymeric’ surfactants which are sensitive to dilution effects during slow intravenous administration, which are quickly metabolised and which therefore do not have a long halflife in plasma, e.g. polysorbate 80.
Additional considerations may apply to certain polymeric surfactant systems developed to create a ‘delivery system’ in addition to a solubilising system and which have special properties affecting kinetics and distribution in vivo, e.g. very low critical micelle concentration (cmc) or prolonged half-life2 (e.g. innovative block co-polymer surfactants) or those oncology products designed to utilise the EPR effect3 (Enhanced Permeability and Retention). Such systems may indeed be characterised in partby the following tests, but it is likely that additional studies could be needed to fully characterise thesproducts in a relevant way.
In micellar solutions, there exists, in rapid dynamic equilibrium, different species of the drug substance (as aqueous solute or drug substance solubilised in the micelle) and surfactant (as monomer or in micelle form). In this way, the drug substance is maintained in solubilsed form and precipitation is avoided. These drug products are normally presented as stable sterile concentrates (e.g. powder and solvent for concentrate solution for infusion, sterile concentrate and solvent for solution for infusion, concentrate for solution for infusion).
The micellar solution is normally prepared for intravenous infusion by dilution with a large volume of aqueous 0.9% sodium chloride or 5% dextrose injection.
On slow intravenous infusion of the products described by the bullet points above, the micellar solution is deaggregated such that the drug substance is presented to the blood compartment in a ‘free’ rather than ‘solubilised’ form. Nevertheless, it should be acknowledged that these are generalisations and that the specific qualities and attributes of the both the drug substance and micellar and formulation excipients need to be specifically considered on a case by case basis.
Given the complexity of micelle systems, a comprehensive pharmaceutical development is necessary, needing an understanding of what happens to the product after administration. It is acknowledged that this development may involve some tests which are not currently well-reported, and applicants are encouraged to develop and validate such techniques for themselves, particularly those which give information on the likely state of these systems in vivo. Therefore, applicants are advised to discuss the pharmaceutical development with the regulatory authorities and/or to seek Scientific Advice from the CHMP.

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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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“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.”

EMA Publish Draft Reflection Paper on IV Micellar Systems

EMA Publish Draft Reflection Paper on IV Micellar Systems

Full Text Here

This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type.
In particular, this text applies in the following contexts cumulatively:
• medicinal products for intravenous injection or infusion which contain active substances, which have a low aqueous solubility and which are therefore solubilised in an aqueous micellar system1, where the main objective of the development is to solubilise the drug, and not to create a system where special size- or surface-dependent properties of the disperse phase are critical factors in the kinetics and disposition of the drug.
• it is particularly relevant to ‘traditional’ or ‘established’ ‘small molecule, non-polymeric’ surfactants which are sensitive to dilution effects during slow intravenous administration, which are quickly metabolised and which therefore do not have a long halflife in plasma, e.g. polysorbate 80.
Additional considerations may apply to certain polymeric surfactant systems developed to create a ‘delivery system’ in addition to a solubilising system and which have special properties affecting kinetics and distribution in vivo, e.g. very low critical micelle concentration (cmc) or prolonged half-life2 (e.g. innovative block co-polymer surfactants) or those oncology products designed to utilise the EPR effect3 (Enhanced Permeability and Retention). Such systems may indeed be characterised in partby the following tests, but it is likely that additional studies could be needed to fully characterise thesproducts in a relevant way.
In micellar solutions, there exists, in rapid dynamic equilibrium, different species of the drug substance (as aqueous solute or drug substance solubilised in the micelle) and surfactant (as monomer or in micelle form). In this way, the drug substance is maintained in solubilsed form and precipitation is avoided. These drug products are normally presented as stable sterile concentrates (e.g. powder and solvent for concentrate solution for infusion, sterile concentrate and solvent for solution for infusion, concentrate for solution for infusion).
The micellar solution is normally prepared for intravenous infusion by dilution with a large volume of aqueous 0.9% sodium chloride or 5% dextrose injection.
On slow intravenous infusion of the products described by the bullet points above, the micellar solution is deaggregated such that the drug substance is presented to the blood compartment in a ‘free’ rather than ‘solubilised’ form. Nevertheless, it should be acknowledged that these are generalisations and that the specific qualities and attributes of the both the drug substance and micellar and formulation excipients need to be specifically considered on a case by case basis.
Given the complexity of micelle systems, a comprehensive pharmaceutical development is necessary, needing an understanding of what happens to the product after administration. It is acknowledged that this development may involve some tests which are not currently well-reported, and applicants are encouraged to develop and validate such techniques for themselves, particularly those which give information on the likely state of these systems in vivo. Therefore, applicants are advised to discuss the pharmaceutical development with the regulatory authorities and/or to seek Scientific Advice from the CHMP.

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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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FDA Guidance, Cellular Therapy for Cardiac Disease

FDA Guidance, Cellular Therapy for Cardiac Disease.

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The FDA, are issuing this guidance to provide you, sponsors who are developing cellular therapies for the treatment of cardiac disease, with recommendations on the design of preclinical and clinical studies, and on the chemistry, manufacturing, and controls (CMC) information to include in an Investigational New Drug application (IND) for cellular theracardiac disease. This guidance also provides recommendations regarding the information thyou should submit on the product’s delivery system. Sponsors should consult with FDA concerning the regulatory pathway for the use of cell selection devices.

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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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EMA, The European Drug Regulatory, Publish Q&A’s for Good Manufacturing Practice (GMP)

EMA, The European Drug Regulatory, Publish Q&A’s for Good Manufacturing Practice (GMP).

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While the European Medicines Agency welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.

From time to time the European Medicines Agency publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.

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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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“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.”

FDA, the US Drug Regulator Publishes Draft Guidance on CMC Post Approval Manufacturing Changes Reportable in Annual Reports

FDA, the US Drug Regulator Publishes Draft Guidance on CMC Post Approval Manufacturing Changes Reportable in Annual Reports

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This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be Reported in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report. Appendix A lists the CMC postapproval manufacturing changes previously submitted under  manufacturing supplements that we have determined to be generally of low risk to product quality (product identity, strength, quality, purity, and potency as they relate to the safety or effectiveness of the product).

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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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ida consultants freestrategyconsultation 515x64 FDA, the US Drug Regulator Publishes Draft Guidance on CMC Post Approval Manufacturing Changes Reportable in Annual Reports

Free Strategy Consultation - Biotech Pharma Regualtory

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ida 100programme 515x64 LowRes FDA, the US Drug Regulator Publishes Draft Guidance on CMC Post Approval Manufacturing Changes Reportable in Annual Reports

Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

Full Text Here

This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following:
1. How new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation (ICH) guidance for industry Q3C Impurities: Residual Solvents (Q3C). This guidance contains recommendations on solvent classification and permitted daily exposure.3
2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapter <467> “Residual Solvents” and the Federal Food, Drug, and Cosmetic Act (the Act).
3. How holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with General Chapter <467> and 21 CFR 314.70.
For recommendations on solvent classification and permitted daily exposure, please refer to the ICH Q3C.

Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA-Derived Products or Monolconal Antibody Products

The FDA has re-posted guidance first published in 1996 “FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE

This guidance provides a section by section description of the Chemistry, manufacturing and control section of an FDA submission, its aimed specifically at Specific Biotech products, but should be considered by other related technologies. There is no apparent reason for the re-posting but it could be the FDA is planning an update.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com