Author: media manager

03 Apr

Posted at 10:39h in Blog
  • The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024.The document adopts a minor revision to section 3.4. concerning the consideration of solvent volatility for analytical methods.

    The Q3C ICH Guideline was finalised under Step 4 in July 1997 and provides recommendations on using of less toxic solvents in the manufacture of drug substances and dosage forms, as well as setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

    As part of the maintenance process, the Q3C Guideline incorporated the revision and inclusion of new Permitted Daily Exposure (PDE) levels as new toxicological data for solvents became available.

    In section 3.4 the guideline states that: “If only Class 3 solvents are present, a non-specific method such as loss on drying may be used, if the method is properly validated. The impact of solvent volatility on the test method should be considered in the validation.

    Validation of methods for residual solvents should conform to the current version of ICH guideline Q2 on Validation of Analytical Procedures”.

    SOURCES:

    ICH: News

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03 Apr

Posted at 10:37h in Blog
  • FDA has published the draft guidance “Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry” to describe the Agency’s current thinking on the use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct surveillance, reduce risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This draft guidance provides answers to frequently asked questions about what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.

    The term “RRA”, as defined in the Question and Answers section, include activities for which the FDA may use different terminologies, such as “remote interactive evaluations” and “remote record reviews“. RRAs were mainly used to support submissions or applications assessments of FDA-regulated products and to reduce delays.

    In the presence of travel restrictions during the COVID-19 pandemic, FDA utilized RRAs to assess establishments and their compliance with applicable FDA requirements.

    Based on this experience, FDA has noted the value of RRAs and concluded that, under certain circumstances, they should be retained for some scenarios outside the COVID-19 pandemic for all types of FDA-regulated products.

    The Agency is also issuing this guidance to promote greater consistency in the way RRAs are conducted, explaining the processes for responding to an RRA request and outlining the factors to consider in assessing whether an establishment has responded timely and appropriately to a mandatory request.

    SOURCES:

    https://www.fda.gov/media/160173/download

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03 Apr

Posted at 10:34h in Blog
  • on January 6, 2024, the Indian Ministry of Health notified the revision of GMP rules in accordance with Schedule M of the Drug and Cosmetic Regulation, with the aim of ensuring robust quality control for pharmaceutical and biopharmaceutical products.

    With this revision, the emphasis is placed on enhancing and updating the existing GMP framework to align with the global standards and international expectations, in particular those of the World Health Organization (WHO). The review was also driven by the rapid evolution of the manufacturing and quality domain and the need to keep pace with the latest technological advances.

    With the amendment, the term ‘Good Manufacturing Practices’ (GMP) has been replaced with “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products”.

    Some of the major changes introduced in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.

    The revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs and also include five new categories of drugs that were not previously covered under the rules.

    The new categories include pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products, radiopharmaceuticals, phytopharmaceuticals, and investigational pharmaceutical products for clinical trials for humans.

    “The manufacturer must assume responsibility for the quality of pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence, and do not place patients at risk due to inadequate safety, quality, or efficacy. The manufacturer must also market a finished product only after getting satisfactory results from tests of the ingredients and retain enough samples of intermediate and final products to allow repeated testing or verification of a batch.” [Health Ministry notifies revised Pharma manufacturing rules under schedule M to ensure quality control – The Hindu].

    SOURCES:

    https://www.thehindu.com/

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