Public Inspection: Revocation of Regulations: Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community From Food and Drug Administration (FDA) πΊπΈ Document number 2024-21559. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated today Other (Public Domain) 0 reuses 0 favorites
GMP Audit Reminders From Ministry of Food and Drug Safety (MFDS) π°π· Get reminders for GMP audits with this document. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on GMP compliance by foreign manufacturers. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on April 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian manufacturing licences and overseas GMP certification From Therapeutic Goods Administration (TGA) π¦πΊ A step-by-step guide for Australian manufacturers of therapeutic goods. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TIWGG meeting summaries From Therapeutic Goods Administration (TGA) π¦πΊ TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to alignβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products From Therapeutic Goods Administration (TGA) π¦πΊ The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage,β¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
International agreements and arrangements for GMP clearance From Therapeutic Goods Administration (TGA) π¦πΊ International agreements and arrangements for GMP clearance Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on December 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GMP clearance guidance From Therapeutic Goods Administration (TGA) π¦πΊ Guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 11, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on current good manufacturing practice requirements for combination products in the pharmaceutical industry. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Manufacture of sterile radiopharmaceuticals labelled with fluorine-18 From Therapeutic Goods Administration (TGA) π¦πΊ Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 30, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 687 of 13/05/2022 From Brazilian Health Regulatory Agency (Anvisa) π§π· Provides for the criteria for granting or renewing the Good Manufacturing Practice Certification for Medical Devices. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2022-03227. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices byβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 23, 2022 Other (Public Domain) 0 reuses 0 favorites
Provision No. 2580/2022 From National Administration of Drugs, Food and Medical Devices (ANMAT) π¦π· The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13 and its amendments shall be processed in accordance with the provisions of thisβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Provision No. 2096/2022 From National Administration of Drugs, Food and Medical Devices (ANMAT) π¦π· The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13, as amended, shall be processed in accordance with the provisions of thisβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence From Therapeutic Goods Administration (TGA) π¦πΊ As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 1, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Webinar presentation: Remote GMP inspections: Current feedback and future considerations From Therapeutic Goods Administration (TGA) π¦πΊ A webinar presentation discussing remote GMP inspections, including current feedback and future considerations. Focuses on manufacturing. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Webinar presentation: Overview of GMP regulatory activities From Therapeutic Goods Administration (TGA) π¦πΊ A webinar presentation providing an overview of GMP regulatory activities in the manufacturing industry. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Webinar presentation: GMP licence applications From Therapeutic Goods Administration (TGA) π¦πΊ Learn about GMP licence applications in this webinar presentation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Webinar presentation: GMP clearance - Common deficiencies From Therapeutic Goods Administration (TGA) π¦πΊ Learn about common deficiencies in GMP clearance with this webinar presentation focused on manufacturing. A valuable guidance resource. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites