Who gmp certificate

• • • • Menu Column 1 • • • • • Menu Column 2 • • • • • • • • Menu Column 3 • • • • • • • • • • • • • Menu Column 1 • • • • • • • Menu Column 2 • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • • • Menu Column 1 • • • • • • • • • • • Menu Column 2 • • • • • • • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • Menu Column 1 • • • • • • Menu Column 2 • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • • • • • • Menu Column 1 • • • • Menu Column 2 • • • • • • • • • • Menu Column 3 • • • • • • • Menu Column 1 • • • Menu Column 2 • • • • Menu Column 3 • • • • • Guidelines relating to vaccines quality assurance are drafted by pharmaceutical specialists, in consultation with other specialists from industry, national institutions and nongovernmental organizations. Preparation of guidelines generally incorporates an extensive consultative procedure. The draft guidelines are evaluated by ECBS at its annual meeting. If considered to be appropriate they are adopted as international standards. Alternatively, ECBS may request that a draft guideline be revised. The WHO Technical Report Series includes all guidelines that have been adopted by ECBS. They are appended as annexes to ECSPP’s annual reports, each of which is published as a WHO Technical Series report. Many of these annexes underpin the procedures and activities of WHO vaccines prequalification and therefore serve as valuable references for manufacturers, regulators and procurers. For exam...

2.1 Any Member State intending to participate in the Scheme may do so by notifying the Director-General of the World Health Organization, in writing, of: • its willingness to participate in the Scheme; • any significant reservations it intends to observe relating to this participation; and • the name and address of its national drug regulatory authority or other competent authority. 2.2 These notifications will be subsequently announced in the monthly WHO Pharmaceutical Newsletter. An updated consolidated list will be published annually in the Newsletter and will be available to governments at other times from: the Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland. (See also section 3.3) 2.3 A Member State may opt to participate solely to control the import of pharmaceutical products and active substances. This intention should be stated explicitly in its notification to the World Health Organization. 2.4 A Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses: • an effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors; • GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform; • effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, includ...

Good Manufacturing Practices (GMP) are critical to ensuring a medical product is quality assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients. Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products. This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP. Developed by the Promoting the Quality of Medicines (PQM) program, which was funded by the U.S. Agency for International Development, this course is readily accessible for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities. The self-paced course includes ten modules on GMP as it relates to: • Medicinal products (finished dosage form) • Active pharmaceutical ingredients (APIs) • Quality risk management • Deviations, root cause analysis (RCA) tools and corrective and preventive action (CAPA) • Validation • Qualification of facilities, equipment, and utilities • Data integrity and co...

• • Services • • - Analytical • - Analytical Method Development • - Biologic Drugs • - Capillary Electrophoresis • - Chiral HPLC & SFC Method Development • - Impurity Isolation and Identification • - Method Development and Validation • - Overview • - Preparative Resolution Processes • - Reference Substances / Qualification • - Analytical Testing Services • - Adhesive Strength • - Amino Acid Analysis • - Batch Release and Stability Lot Testing • - BET Surface Area • - Bulk and Tapped Density • - Capillary Electrophoresis • - Chromatography (TLC / LC / HPLC / UPLC / GC) • - Complete Pharmacopoeial / Compendial Testing • - Content Uniformity / Homogeneity • - Disintegration • - Dissolution • - DSC • - Friability • - FTIR / NIR • - Gas Testing • - Hardness • - High Potency APIs (HPAPIs) • - Hot-Stage Optical Microscopy • - Impurity Isolation and Identification • - Inhalation Products • - Isoelectric Focusing • - Karl Fischer / Water Analysis • - LC - MS - MS • - Light Microscopy • - MALDI-TOF Mass Spectrometry • - Mass Spectrometry and GC / MS • - Mass Spectrometry and LC / MS • - Microbiology • - Moisture Sorption • - Native Gel Electrophoresis • - Osmotic Strength / Osmometer • - Overview • - Particle Size • - Particulate Matter • - Pharmaceutical Water • - Physical Characterization • - pKa and LogP • - Potentiometry • - Raman • - Residual Solvents • - SEM • - Solid State Characterization • - Solid State NMR • - Solution NMR-Carbon • - Solution NMR-proton • - Sorption and De...

• • • • Menu Column 1 • • • • • Menu Column 2 • • • • • • • • Menu Column 3 • • • • • • • • • • • • • Menu Column 1 • • • • • • • Menu Column 2 • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • • • Menu Column 1 • • • • • • • • • • • Menu Column 2 • • • • • • • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • Menu Column 1 • • • • • • Menu Column 2 • • • • • • • • • • • Menu Column 3 • • • • • • • • • • • • • • • • • • • Menu Column 1 • • • • Menu Column 2 • • • • • • • • • • Menu Column 3 • • • • • • • Menu Column 1 • • • Menu Column 2 • • • • Menu Column 3 • • • • • Guidelines relating to vaccines quality assurance are drafted by pharmaceutical specialists, in consultation with other specialists from industry, national institutions and nongovernmental organizations. Preparation of guidelines generally incorporates an extensive consultative procedure. The draft guidelines are evaluated by ECBS at its annual meeting. If considered to be appropriate they are adopted as international standards. Alternatively, ECBS may request that a draft guideline be revised. The WHO Technical Report Series includes all guidelines that have been adopted by ECBS. They are appended as annexes to ECSPP’s annual reports, each of which is published as a WHO Technical Series report. Many of these annexes underpin the procedures and activities of WHO vaccines prequalification and therefore serve as valuable references for manufacturers, regulators and procurers. For exam...

• • Services • • - Analytical • - Analytical Method Development • - Biologic Drugs • - Capillary Electrophoresis • - Chiral HPLC & SFC Method Development • - Impurity Isolation and Identification • - Method Development and Validation • - Overview • - Preparative Resolution Processes • - Reference Substances / Qualification • - Analytical Testing Services • - Adhesive Strength • - Amino Acid Analysis • - Batch Release and Stability Lot Testing • - BET Surface Area • - Bulk and Tapped Density • - Capillary Electrophoresis • - Chromatography (TLC / LC / HPLC / UPLC / GC) • - Complete Pharmacopoeial / Compendial Testing • - Content Uniformity / Homogeneity • - Disintegration • - Dissolution • - DSC • - Friability • - FTIR / NIR • - Gas Testing • - Hardness • - High Potency APIs (HPAPIs) • - Hot-Stage Optical Microscopy • - Impurity Isolation and Identification • - Inhalation Products • - Isoelectric Focusing • - Karl Fischer / Water Analysis • - LC - MS - MS • - Light Microscopy • - MALDI-TOF Mass Spectrometry • - Mass Spectrometry and GC / MS • - Mass Spectrometry and LC / MS • - Microbiology • - Moisture Sorption • - Native Gel Electrophoresis • - Osmotic Strength / Osmometer • - Overview • - Particle Size • - Particulate Matter • - Pharmaceutical Water • - Physical Characterization • - pKa and LogP • - Potentiometry • - Raman • - Residual Solvents • - SEM • - Solid State Characterization • - Solid State NMR • - Solution NMR-Carbon • - Solution NMR-proton • - Sorption and De...

Good Manufacturing Practices (GMP) are critical to ensuring a medical product is quality assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients. Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products. This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP. Developed by the Promoting the Quality of Medicines (PQM) program, which was funded by the U.S. Agency for International Development, this course is readily accessible for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities. The self-paced course includes ten modules on GMP as it relates to: • Medicinal products (finished dosage form) • Active pharmaceutical ingredients (APIs) • Quality risk management • Deviations, root cause analysis (RCA) tools and corrective and preventive action (CAPA) • Validation • Qualification of facilities, equipment, and utilities • Data integrity and co...

2.1 Any Member State intending to participate in the Scheme may do so by notifying the Director-General of the World Health Organization, in writing, of: • its willingness to participate in the Scheme; • any significant reservations it intends to observe relating to this participation; and • the name and address of its national drug regulatory authority or other competent authority. 2.2 These notifications will be subsequently announced in the monthly WHO Pharmaceutical Newsletter. An updated consolidated list will be published annually in the Newsletter and will be available to governments at other times from: the Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland. (See also section 3.3) 2.3 A Member State may opt to participate solely to control the import of pharmaceutical products and active substances. This intention should be stated explicitly in its notification to the World Health Organization. 2.4 A Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses: • an effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors; • GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform; • effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, includ...

• • Services • • - Analytical • - Analytical Method Development • - Biologic Drugs • - Capillary Electrophoresis • - Chiral HPLC & SFC Method Development • - Impurity Isolation and Identification • - Method Development and Validation • - Overview • - Preparative Resolution Processes • - Reference Substances / Qualification • - Analytical Testing Services • - Adhesive Strength • - Amino Acid Analysis • - Batch Release and Stability Lot Testing • - BET Surface Area • - Bulk and Tapped Density • - Capillary Electrophoresis • - Chromatography (TLC / LC / HPLC / UPLC / GC) • - Complete Pharmacopoeial / Compendial Testing • - Content Uniformity / Homogeneity • - Disintegration • - Dissolution • - DSC • - Friability • - FTIR / NIR • - Gas Testing • - Hardness • - High Potency APIs (HPAPIs) • - Hot-Stage Optical Microscopy • - Impurity Isolation and Identification • - Inhalation Products • - Isoelectric Focusing • - Karl Fischer / Water Analysis • - LC - MS - MS • - Light Microscopy • - MALDI-TOF Mass Spectrometry • - Mass Spectrometry and GC / MS • - Mass Spectrometry and LC / MS • - Microbiology • - Moisture Sorption • - Native Gel Electrophoresis • - Osmotic Strength / Osmometer • - Overview • - Particle Size • - Particulate Matter • - Pharmaceutical Water • - Physical Characterization • - pKa and LogP • - Potentiometry • - Raman • - Residual Solvents • - SEM • - Solid State Characterization • - Solid State NMR • - Solution NMR-Carbon • - Solution NMR-proton • - Sorption and De...

Good Manufacturing Practices (GMP) are critical to ensuring a medical product is quality assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients. Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products. This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP. Developed by the Promoting the Quality of Medicines (PQM) program, which was funded by the U.S. Agency for International Development, this course is readily accessible for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities. The self-paced course includes ten modules on GMP as it relates to: • Medicinal products (finished dosage form) • Active pharmaceutical ingredients (APIs) • Quality risk management • Deviations, root cause analysis (RCA) tools and corrective and preventive action (CAPA) • Validation • Qualification of facilities, equipment, and utilities • Data integrity and co...