The effect of developing technology in the pharmaceutical industry

The effect of developing technology in the pharmaceutical industry

    PhD (c) CEM ÇALIŞKAN
    Analitik Geliştirme Müdürü

    Today, in line with technological development, the importance given to human health has increased.

    While determining hazardous substances containing in the products that we use such as food, medicine, cosmetic etc. and that may threaten our health, the analyzes of such parameters as the determination of the quantity, the uniformity of the content, the control of moisture, dissolution, and the control of the impurities originating from the active substances or excipients are considered insufficient.

    National and international authorities such as International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), World Health Organisation (WHO), American Food and Drug Administration (FDA), European Medicine Agency (EMA) and Ministry of Health of Turkish Republic, have increased their engagement to impurity studies. In this scope, new necessities appear everyday.The medicines and medical devices should not contain any impurities that may harm patients, and the safety of the medicine from production to package materials and even to storage, should be guaranteed. For a medicine, any component, which is not specified in the formulation, is accepted as impurity. If these impurities are not detected and removed, quality, safety and efficacy of the medicinal products will be open to question.

    What is the awareness raised by of high-tech devices?

    In 1980s, USA Food and Drug Administration (FDA), after the concerns about symptoms of patient susceptibility arising from extractable and penetrable impurities and concerns about potential safety, indicated that there are many dosage forms being accepted as high risk, especially by route of administration due to interaction between packaging system and dosage form. Pharmaceutical impurities are undesirable chemicals that coexist with active pharmaceutical ingredients (APIs) or drug product formulations.

    Identification, quantification, qualification and control of impurities are critical parts of the drug development process, as the quality and quantity of impurities present in pharmaceutical substances determine the safety of the finished pharmaceutical product. Various regulatory authorities such as ICH, FDA and EMA focus on the control of impurities and release guidelines on these issues.

    Extractables refer to all organic and inorganic chemical structures that may be released into the solvent by extraction from a pharmaceutical packaging product.

    Extractable substances have the potential of leaking into a medicinal product under normal storage and application conditions so that they become penetrable.Penatrable substances mean foreign chemicals that may leak into a packaged medicine under normal storage and applicatiob conditions or during accelerated stability studies.

    Apart from producing quality product, for ensuring the sustainability of the product quality, pharmaceutical companies have to prevent the passage of potentially harmful materials from packaging to patients.

     In June 2018, due to the detection of the impurity called N-nitrosodimethylamine (NDMA) in some pharmaceutical products and raw materials containing Valsartan and known to be carcinogenic, health authorities such as FDA, EMA recalled these products to perform controls, and issued respective regulations.

    In 2019, restrictions were imposed by the authorities on the elemental impurities that may leak from the chemicals used as catalysts in the production process, to the active substances or excipients used to prevent and alleviate the acid reflux, such as ranitidine, which do not have healing properties for the patients, but can penetrate from production equipment or container-lid systems.

    Especially in ICH Q3D (R1) guide, some elements are divided into 3 groups according to their toxicitity and ability of aaccumulation in a medicinal product, and their daily exposure limit.

    With all these reasons, national and international regulations require some advanced analytic studies as follows:

    • Determining unknown impurities in medicines,
    • Control of genotoxic, carcinogenic, teratogenic impurities,
    • Control of extractable and penetrable impurities that may arise from primary packaging or storage conditions during stability process,
    • Nitrosamine impurities,
    • Elemental impurity,
    • Unknown impurities determination.

    On a country’s level, where are we now at contributing medicine quality by using advanced technology?

    There are leading companies in our country that have established private laboratories by making large investments in order to increase our national drug quality and to carry out these analyzes without being dependent on foreign sources. In these labs, many analyses, which are important for product quality, such as elemental impurity and heavy metal determination, determining unknown impurities by means of library scanings, determining extractable profiles in package substances and control of penatrables in the products, detecting nitrosamine impurities are performed. These advanced analytical studies are carried out by strong and skilled R&D team of professionals with master and PhD degrees and laboratory personnel qualified for equipment use.

    IMPORTANCE AND EFFECT OF TODAY’S TECHNOLOGY ON MEDICINE INDUSTRY

    We are able to innovate our products and production processes, increase product quality and standards, perform commercialization of technological knowledge, and development of pre-competitive cooperation by producing technological knowledge in order to bring the country’s economy into an internationally competitive structure through R&D and innovation.

    If we think your health as a treasure for us, we are working very hard for its protection, with the awareness that we should work harder and produce more by using daily developing technology.

    What does Turkey do for medicine analyses not to depend on foreign resourses?

    To make the economy of the country competitive in international level through R&D innovation, first, we should produce technological information, make innovation on products and production process, increase product quality and standards.

    Also, produced technological information being commercialized and coperations being developed before competitiveness will save our country from depending on outside.

    Today, in line with technological development, the importance given to human health has increased.

    While determining hazardous substances containing in the products that we use such as food, medicine, cosmetic etc. and that may threaten our health, the analyzes of such parameters as the determination of the quantity, the uniformity of the content, the control of moisture, dissolution, and the control of the impurities originating from the active substances or excipients are considered insufficient.

    National and international authorities such as International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), World Health Organisation (WHO), American Food and Drug Administration (FDA), European Medicine Agency (EMA) and Ministry of Health of Turkish Republic, have increased their engagement to impurity studies. In this scope, new necessities appear everyday.The medicines and medical devices should not contain any impurities that may harm patients, and the safety of the medicine from production to package materials and even to storage, should be guaranteed. For a medicine, any component, which is not specified in the formulation, is accepted as impurity. If these impurities are not detected and removed, quality, safety and efficacy of the medicinal products will be open to question.

    What is the awareness raised by of high-tech devices?

    In 1980s, USA Food and Drug Administration (FDA), after the concerns about symptoms of patient susceptibility arising from extractable and penetrable impurities and concerns about potential safety, indicated that there are many dosage forms being accepted as high risk, especially by route of administration due to interaction between packaging system and dosage form. Pharmaceutical impurities are undesirable chemicals that coexist with active pharmaceutical ingredients (APIs) or drug product formulations.

    Identification, quantification, qualification and control of impurities are critical parts of the drug development process, as the quality and quantity of impurities present in pharmaceutical substances determine the safety of the finished pharmaceutical product. Various regulatory authorities such as ICH, FDA and EMA focus on the control of impurities and release guidelines on these issues.

    Extractables refer to all organic and inorganic chemical structures that may be released into the solvent by extraction from a pharmaceutical packaging product.

    Extractable substances have the potential of leaking into a medicinal product under normal storage and application conditions so that they become penetrable.Penatrable substances mean foreign chemicals that may leak into a packaged medicine under normal storage and applicatiob conditions or during accelerated stability studies.

    Apart from producing quality product, for ensuring the sustainability of the product quality, pharmaceutical companies have to prevent the passage of potentially harmful materials from packaging to patients.

    In June 2018, due to the detection of the impurity called N-nitrosodimethylamine (NDMA) in some pharmaceutical products and raw materials containing Valsartan and known to be carcinogenic, health authorities such as FDA, EMA recalled these products to perform controls, and issued respective regulations.

    In 2019, restrictions were imposed by the authorities on the elemental impurities that may leak from the chemicals used as catalysts in the production process, to the active substances or excipients used to prevent and alleviate the acid reflux, such as ranitidine, which do not have healing properties for the patients, but can penetrate from production equipment or container-lid systems.

    Especially in ICH Q3D (R1) guide, some elements are divided into 3 groups according to their toxicitity and ability of aaccumulation in a medicinal product, and their daily exposure limit.

    With all these reasons, national and international regulations require some advanced analytic studies as follows:

    • Determining unknown impurities in medicines,
    • Control of genotoxic, carcinogenic, teratogenic impurities,
    • Control of extractable and penetrable impurities that may arise from primary packaging or storage conditions during stability process,
    • Nitrosamine impurities,
    • Elemental impurity,
    • Unknown impurities determination.

    On a country’s level, where are we now at contributing medicine quality by using advanced technology?

    There are leading companies in our country that have established private laboratories by making large investments in order to increase our national drug quality and to carry out these analyzes without being dependent on foreign sources. In these labs, many analyses, which are important for product quality, such as elemental impurity and heavy metal determination, determining unknown impurities by means of library scanings, determining extractable profiles in package substances and control of penatrables in the products, detecting nitrosamine impurities are performed. These advanced analytical studies are carried out by strong and skilled R&D team of professionals with master and PhD degrees and laboratory personnel qualified for equipment use.

    IMPORTANCE AND EFFECT OF TODAY’S TECHNOLOGY ON MEDICINE INDUSTRY

    We are able to innovate our products and production processes, increase product quality and standards, perform commercialization of technological knowledge, and development of pre-competitive cooperation by producing technological knowledge in order to bring the country’s economy into an internationally competitive structure through R&D and innovation.

    If we think your health as a treasure for us, we are working very hard for its protection, with the awareness that we should work harder and produce more by using daily developing technology.

    What does Turkey do for medicine analyses not to depend on foreign resourses?

    To make the economy of the country competitive in international level through R&D innovation, first, we should produce technological information, make innovation on products and production process, increase product quality and standards.

    Also, produced technological information being commercialized and coperations being developed before competitiveness will save our country from depending on outside.

    As a consequence, when we think about today’s and tomorrow’s pharmaceutical industry in both national and international perspective, with good investments, strong R&D teams, digital technologies and cooperations, we will accelerate advanced device and analytic studies for preservation of human health in our country.

    Resources

    1- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems, Currently Official as of 1-Dec-2020.

    2- USP <1664> Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems, Currently Official as of 1-Dec-2020.

    3- Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, FDA, May,1999.

    4- Control of Nitrosamine Impurities in Human Drugs, FDA, September 2020.

    5- ICH Q3D (R1) Guideline for Elementel Impurities, Final version, Adopted on 22 March 2019.

    As a consequence, when we think about today’s and tomorrow’s pharmaceutical industry in both national and international perspective, with good investments, strong R&D teams, digital technologies and cooperations, we will accelerate advanced device and analytic studies for preservation of human health in our country.

    Resources

    1- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems, Currently Official as of 1-Dec-2020.

    2- USP <1664> Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems, Currently Official as of 1-Dec-2020.

    3- Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, FDA, May,1999.

    4- Control of Nitrosamine Impurities in Human Drugs, FDA, September 2020.

    5- ICH Q3D (R1) Guideline for Elementel Impurities, Final version, Adopted on 22 March 2019.

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