Regulations and Guidelines
Showing 81–96 of 133 results
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Q&A on cGMP Good Guidance Practices – Records and Reports
In this publication from www.FDA.gov, the FDA answers the question: How do the Part 11 regulations and “predicate rule requirements” in 21 CFR 211 apply to chromatograms
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FDA Guidance: Inspection of Clinical Investigators, 6/10
Published in June, 2010 to provide information about FDA inspections of clinical investigators conducted under FDA’s Bioresearch Monitoring (BIMO) Program.
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FDA ORA Laboratory Manual: Basic Statistics and Data Presentation, 4/10
This FDA manual provides FDA personnel with information on internal procedures for testing consumer products. Note section 4.5 on spreadsheet validation.
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Brazilian Good Practices of Medicament Manufacturing, 4/10
The Brazilian Good Practices of Medicament Manufacturing was adopted by the Brazilian National Health Surveillance Agency (ANVISA) on April 12, 2010.
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EC Council Directives related to In Vitro Medical Devices, 8/09
The cumulative directives of the European Parliament and Council from October 1998 through August, 2009 regarding in vitro diagnostic medical devices.
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FDA Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion, 5/09
In May 2009, the FDA published this draft guidance. Web site designers and builders will want to review section III.C.2., Non-Print Promotion, for specific design requirements.
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Japan MHLW Ordinance 36 Good Clinical Practice for Medical Devices, 3/09
Japan’s ordinance on Medical Device GCP provides standards to ensure the scientific quality of clinical trials and the reliability of clinical trial data.
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PIC/S PI 030-1 Aide-Memoire: Inspection of Active Pharmaceutical Ingredients, 1/09
This 2009 inspector’s guide directs focus towards control room system validation & back-ups, material status control system validation & security.
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PIC/S PI 028-1 PIC/S Aide-Memoire: GMP Inspection Related to Packaging, 1/09
This 2009 inspector’s guide directs focus towards electronic devices to establish identity, electronic batch records, security and electronic signatures.
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FDA Guidance: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, 9/08
This guidance document provides recommendations for diagnostic ultrasound systems and transducers. See checklist for hardware, software, and change specifics.
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Japan MHLW Ordinance 37 Good Laboratory Practice for Nonclinical Safety Studies for Medical Devices, 6/08
Japan’s 2008 Ministerial Ordinance provides GLP standards for conducting nonclinical safety studies of medical devices at test facilities or test sites.
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Japan MHLW Ordinance 21 Good Laboratory Practice for Nonclinical Safety Studies of Drugs, 6/08
Japan’s 2008 Ministerial Ordinance provides GLP standards for conducting nonclinical safety studies of drugs at test facilities or test sites.
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Eudralex V10 Ch IV: Guidelines for the Conduct of GCP Inspections, 5/08
This document provides a framework for conducting Good Clinical Practice (GCP) inspections. Annex III provides additional guidance for computer system inspections.
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Eudralex V10 Ch IV Annex III: Guidelines for the Conduct of GCP Inspections – Computerised Systems, 5/08
This guide for GCP inspections refers readers to the PIC/S document “Guidance on Good Practices for Computerised Systems in Regulated ‘GXP’ Environments”, PI-011-3.
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Eudralex V4 Annex 20: GMP Guidelines for Quality Risk Management, 2/08
This annex to Volume 4 outlines a program of quality risk management. See section II.4 for potential application for computer systems.
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EMEA Procedure For Conducting GCP Inspections Requested by the EMEA: Annex III Computer Systems, 11/07
This document recommends using the PIC/S publication Guidance on Good Practices for Computerised Systems in “GxP” Environments when performing inspections. ﾠ
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