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REGULATORY AFFAIRS – NITROSAMINES: WHICH STEPS SHOULD BE TAKEN?

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In June 2018, N-nitrosodimethylamine (NDMA) and similar compounds known as nitrosamines, classified as probable human carcinogen based on animal studies, were unexpectedly found in several blood pressure medicines known as sartans leading to some recalls and resulting in new manufacturing requirements and stricter limits for nitrosamines for these medicinal products. Traces of NDMA have also been found in the active substance pioglitazone hydrochloride; however, considering that the levels of this impurity were within the temporary limits set after the review of sartans, no action was taken about the products on the market. In September 2019, EMA started an EU-wide review of ranitidine medicines after tests showed that some of these products too contained the impurity NMDA. Considering the above-mentioned events, as a precaution, the Committee for Medicinal Products for Human Use (CHMP) asked to all Marketing Authorization Holders (MAHs) to review the medicinal pro
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Drug Master File (DMF) in China

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Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application. Before called CFDA, now the National Medical Products Administration (NMPA) had a pre-market approval policy that allowed APIs, excipients and packaging materials to be registered separately with pharmaceutical product application. The process usually took longer and was more expensive. The new system allows these manufacturers to file the DMF reducing the approval time and respective cost involved. Pharmaceutical manufacturers can refer to the DMF code while submitting the drug application making the process more efficient. Who Can File a Drug Master File (DMF)? The following category of companies inden
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GAP or Findings in Regulatory Compliance

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Gap Analysis for Regulatory Compliance Gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance. If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis. Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities of improvement. The room for improvement is identified by gap analysis. Therefore, make the checklists of the document you want to analyze and then check the actual working against the checklist. Gap analysis should also be done for regulatory guidelines like data integrity, risk assessment, good manufacturing practices, good laboratory practices, good documentation practices, good distribution practices etc to eliminate the possible non-compliances. Gap analysis may be carried out for specific i
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Overview of CTD vs ACTD

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OVERVIEW OF ICH – CTD AND ACTD In the present section an attempt has been made to compare the drug regulatory approval procedure and requirements for the registration of pharmaceuticals for human use ICH countries and ASEAN. The main points of divergence are in the content and format of the registration dossier. The ACTD consists of Parts I to IV which have subsections A to F whereas ICH – CTD has 5 Modules with subsections that are numbered. The administrative data of Part I is part of ACTD whereas Module 1 of ICH – CTD is purely country specific. The summaries of the quality (Part II), nonclinical (Part III) and clinical (Part IV) are located at the beginning of each part of the ACTD. The ICH – CTD dedicates these summaries in a separate Module 2. As the ACTD does not have such summary part, it consists of only 4 Parts and not 5. The main differences between the ICH - CTD and ACTDare listed below in Table II. Table II:  Overview of ICH – CTD and ACTD DOCUMENTS ICH - CTD
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ACTD

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The ASEAN Common Technical Document is organized into four parts. Part I.  Table of Contents, Administrative Data and Product Information Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in details is put together such as application forms, label, and package insert etc. The last section of this part is Product Information where necessary information includes prescribed information, mode of action, side effects etc. A.        Introduction B.        Table of Contents C.        Administrative Data and Product Information 1.         Application Form 2.         Letter of Authorization 3.         Certifications 4.         Labelling 5.         Product Information Part II. Quality Document Part II should provide the Overall Summary followed by the Study Reports. The quality control documen
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Guidelines for preparation of dossier

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Module 3: Quality Information on Quality should be presented in the structured format as described below: 3.1      Table of Contents of Module 3 3.2          Body of Data 3.2. S              Drug substance(s) 3.2. S.1            General Information 3.2. S.2           Manufacture of Drug Substance (name, manufacturer) 3.2. S.3            Characterization of Drug Substance (name, manufacturer) 3.2. S.4            Quality Control of Drug Substance (name, manufacturer) 3.2. S.5            Reference Standards or Materials (name, manufacturer) 3.2. S.6            Container Closure System (name, manufacturer) 3.2. S.7            Stability of Drug Substance (name, manufacturer) 3.2. P               Drug product (name, dosage form) 3.2. P.1            Description and Composition of the Drug Product (name, dosage form) 3.2. P.2           Pharmaceutical Development (name, dosage form) 3.2. P.3          Manufacture of drug product (name, dosage form) 3.2. P.4          Controls of Excipients (nam
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