Tanzania Food and Drugs Authority (TFDA)

فهرست عناوین اصلی در این پاورپوینت

فهرست عناوین اصلی در این پاورپوینت

● Role of National Drug Regulatory Authorities in Procurement and Supply Management
● Tanzania Food and Drugs Authority (TFDA)
● Technical HR capacity
● Key Regulatory Functions
● Drug Registration
● Technical information required in registration dossiers
● Assessment of registration dossiers
● Pre-registration GMP inspection
● Overseas sites inspected in the last 2 years (data as of April 2005)
● Licensing, Inspection & Surveillance
● Quality Control laboratory
● Drug Quality Assurance Programme
● GPHF Minilab Launch
Oct, 2002
● QA Program to strengthen PMS
● QA Program and Strengthening PMS
● Impact of Drug QA Programme
● Impact 2
● Control of importation
● Pharmacovigilance…
● Pharmacovigilance
● Other important information
● THANK YOU VERY MUCH

نوع زبان: انگلیسی حجم: 0.39 مگا بایت
نوع فایل: اسلاید پاورپوینت تعداد اسلایدها: 23 صفحه
سطح مطلب: نامشخص پسوند فایل: ppt
گروه موضوعی: زمان استخراج مطلب: 2019/05/17 02:39:49

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عبارات مهم استفاده شده در این مطلب

عبارات مهم استفاده شده در این مطلب

drug, product, ., quality, inspection, inspector, registration, food, guideline, site, datum, control,

توجه: این مطلب در تاریخ 2019/05/17 02:39:49 به صورت خودکار از فضای وب آشکار توسط موتور جستجوی پاورپوینت جمع آوری شده است و در صورت اعلام عدم رضایت تهیه کننده ی آن، طبق قوانین سایت از روی وب گاه حذف خواهد شد. این مطلب از وب سایت زیر استخراج شده است و مسئولیت انتشار آن با منبع اصلی است.

http://origin.who.int/hiv/amds/QualityAssuranceTanzania.ppt

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عبارات پرتکرار و مهم در این اسلاید عبارتند از: drug, product, ., quality, inspection, inspector, registration, food, guideline, site, datum, control,

مشاهده محتوای متنیِ این اسلاید ppt

مشاهده محتوای متنیِ این اسلاید ppt

role of national drug regulatory authorities in procurement and supply management hiiti sillo tanzania food and drugs authority tfda psm technical briefing seminar for consultants wednesday ۱st february ۲ ۶ the zonal structure which is providing enhanced training of health workers to physically examine products for defects and also have capacity to perform screening tests for api identification. tanzania food and drugs authority tfda established by the tanzania food drugs and cosmetics act ۲ ۳. inherited functions of defunct pharmacy board an executive agency under the ministry of health it is the regulatory body responsible for control of quality and safety of food drugs including herbal drugs cosmetics and medical devices. vision to become the best regulatory authority in regulating food drugs cosmetics and medical devices in africa by ۲ ۱۵ technical hr capacity ۱۶ pharmacists with msc m.pharm mph ۱۱ pharmacists with bpharm ۳ veterinary surgeons ۱ chemist with msc technicians admin and finance staff food technologists health officers key regulatory functions drug registration drug inspection gmp and surveillance licensing of pharmaceutical manufacturers importers and distributors control of importation of pharmaceuticals quality control laboratory pharmacovigilance adverse drugs reactions drug registration according to the law all drugs to be manufactured for sale imported or supplied must be registered sect.۲۲ criteria for registration is provided in the law availability of the drug is in the public interest it is safe efficacious and of acceptable quality the site and manufacturing operations complies with current gmp adapted who guidelines to facilitate registration process guidelines available on www.tfda.or.tz technical information required in registration dossiers generics certificate of pharmaceutical product cpp – who type summary of product characteristics spcs quality of apis quality of finished dosage form manufacturing quality control stability data labeling etc therapeutic equivalence data new drugs certificate of pharmaceutical product cpp – who type spcs quality data on apis and fp as in generics safety preclinical data clinical data incl. clinical trials data assessment of registration dossiers documents assessed trained and qualified tfda assessors external experts from university and research organizations assessment is based on fifo time to register products put in guidelines ۱۲ months if no queries raised ۳ months for arvs antimalarials and antitb priority products evaluation fast tracked to facilitate access client service charter launched by minister for health on ۲۷th jan ۲ ۶ spells commitment of service delivery timeframes pre registration gmp inspection applicable to both local and overseas sites before products are registered exception to ich countries and some pic s countries – rely on documents submitted cpp gmp inspection ۹ competent gmp inspections criteria based on who guidelines overseas sites inspected in the last ۲ years data as of april ۲ ۵ year no. of sites inspected no. of sites passed cgmp no. of sites failed cgmp failed ۲ ۳ ۴ ۳۵ ۲۶ ۹ ۲۵.۷۱ ۲ ۴ ۵ ۵۴ ۳۳ ۲۱ ۳۸.۸۹ licensing inspection surveillance inspections are done to ensure compliance to legal and licensing requirements inspectors have been appointed at tfda hq and regional levels the law requires all manufacturers and distributors of pharmaceutical products to hold valid licenses permits premises are inspected before licensing quality control laboratory tfda laboratory established in ۲ has the capacity to handle most of the analytical work analysis of registration samples analysis of pms samples samples sent to the lab after primary screening at poes or by other inspectors through the qa programme the lab is now moving towards accreditation quality manual in final stage assessed by who for pre qualification in ۲ ۵ – some gaps need to be addressed drug quality assurance programme launched in ۲ ۲ for quick screening of pharmaceuticals being imported and those produced locally using simple tlc techniques the program was technically assisted by msh seam for ۳ years ending june ۲ ۵ the program uses minilab kits developed by the german pharma health fund gphf gphf minilab launch oct ۲ ۲ in october ۲ ۲ the tanzania food and drugs authority initiated an inspection and testing program based on the german pharma health fund minilab technology. although it has been difficult for some individuals to make a decision on a substandard product by the visual comparison of the sample and reference product on the thin layer chromatography plates the decision that the active ingredient is not present is very straightforward. qa program to strengthen pms key areas of the drug quality assurance program inspection and testing of drugs at the major ports of entry and the medical stores department ۱ tlc minilab screening sites established for product physical examinations and api identification for targeted antimalarials antibiotics and antiretroviral drugs. qa program and strengthening pms training of drug inspectors countrywide ۳۲۹ inspectors trained. trained inspectors are provided with inspectors handbook developed with ta from msh – seam reviewed current guidelines for control of importation of drugs development of inspection guidelines and sops at all levels. impact of drug qa programme overall pms system improved through the development and use of inspectors handbook containing inspection forms sampling procedures sops checklists ethics products at poes and those in circulation comply with quality standards see next slide impact ۲ decrease in substandard drugs in the market from ۱۳ in ۲ ۱ for samples tested in the laboratory to ۳.۷ among ۱ ۲۵۷ screened drug samples in ۲ ۵ guidelines and sops for inspection now in place pda system for poe inspectors in use now gets financial support from global fund buy more kits and hplcs densitometer training etc control of importation ensures imported products are registered and authorized for importation at poes inspectors check the coa to verify whether the coa has been signed and stamped by authorized person s if the reported test results are within specification limits if products with more than ۲۴ months shelf life have ۶ of their shelf life remaining if products with less than ۲۴ months shelf life have ۸ of their shelf life remaining pharmacovigilance… in tanzania tfda is responsible for monitoring adrs. prepaid reporting forms circulated to healthcare workers in hospitals received cases are assessed by expert committee which recommends appropriate regulatory action modification of patient information leaflets withdrawal of the product from the market ۶۷ and ۷۵ cases reported in ۲ ۳ ۴ and ۲ ۴ ۵ …

کلمات کلیدی پرکاربرد در این اسلاید پاورپوینت: drug, product, ., quality, inspection, inspector, registration, food, guideline, site, datum, control,

این فایل پاورپوینت شامل 23 اسلاید و به زبان انگلیسی و حجم آن 0.39 مگا بایت است. نوع قالب فایل ppt بوده که با این لینک قابل دانلود است. این مطلب برگرفته از سایت زیر است و مسئولیت انتشار آن با منبع اصلی می باشد که در تاریخ 2019/05/17 02:39:49 استخراج شده است.

http://origin.who.int/hiv/amds/QualityAssuranceTanzania.ppt

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