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General Principles of Software Validation; Final Guidance for Industry and FDA Staff
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.
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2002-01-11 |
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Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers/Labellers, Distributors and Importers
This guidance has been prepared to specify what documented evidence the Health Products and Food Branch Inspectorate (HPFBI) considers acceptable during an inspection, from drug establishments, to demonstrate compliance with validation requirements, Health Canada
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2001-07-10 |
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Bioanalytical Method Validation
This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, FDA
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2001-05-01 |
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Process Validation: Aseptic Processes for Pharmaceuticals
This document is intended to provide pharmaceutical dosage form manufacturers with guidance on the validation of aseptic manufacturing processes, as required in Division 2, Part C (Good Manufacturing Practices) of the Food and Drug Regulations, and in a manner which is acceptable to the Therapeutic Products Programme. Health Canada
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2001-03-01 |
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Process Validation: Gaseous Sterilization for Pharmaceuticals
This document is intended to provide guidance to establish the scientific effectiveness of ethylene oxide sterilization procedures, Health Canada
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2001-03-01 |
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Process Validation : Irradiation Sterilization for Pharmaceuticals
The purpose of this document is to provide guidance to manufacturers of pharmaceutical dosage forms regarding how to establish the scientific effectiveness of radiation sterilization processes when used to produce pharmaceutical products, Health Canada
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2001-03-01 |
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Process Validation : Moist Heat Sterilization for Pharmaceuticals
This document is intended to provide manufacturers of pharmaceutical dosage forms with guidance to establish the scientific effectiveness of moist heat sterilization processes, Health Canada
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2001-03-01 |
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Process Validation : Aseptic Processes for Pharmaceuticals
This document is intended to provide pharmaceutical dosage form manufacturers with guidance on the validation of aseptic manufacturing processes, Health Canada
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2001-03-01 |
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Process Validation : Form-Fill-Seal for Drugs
This document is intended to provide drug dosage form manufacturers with guidance on the validation of Form-Fill-Seal (also known as "Blow-Fill-Seal") processes, Health Canada
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2001-03-01 |
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Process Validation : Gaseous Sterilization for Pharmaceuticals
This document is intended to provide guidance to establish the scientific effectiveness of ethylene oxide sterilization procedures. Health Canada
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2001-03-01 |
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EU Annex 15: Qualification and Validation
This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. European Comission
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2001-01-01 |
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ICCVAM Authorization Act of 2000
An Act to establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness, Public Law 106-545
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2000-12-19 |
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Analytical Procedures and Methods Validation (Chemistry, Manufacturing, and Controls Documentation)
This guidance provides recommendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products, FDA
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2000-08-01 |
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Cleaning Validation Guidelines
This document on Cleaning Validation is intended to address special considerations and issues pertaining to validation of cleaning procedures for equipment used in the manufacture of pharmaceutical products, radiopharmaceuticals, and biological drugs, Health Canada
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2000-05-01 |
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Guidance for Industry Analytical Procedures and Methods Validation
This guidance provides recommendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. FDA
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2000-01-01 |
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Data Validation Standard Operating Procedures for Contract Laboratory Program Routine Analytical Services
The purpose of this document is to promote uniformity of data review, to help clarify and augment the review guidance of the National Functional Guidelines, to give guidance for areas of data review that require considerable professional judgement, and to specify procedures that are unique to the needs of Region IV, US. EPA
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1999-07-01 |
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Process Validation Guidance
This guidance provides general suggestions on ways manufacturers may prepare for and carry out process validations, The Global Harmonization Task Force
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1999-06-29 |
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QSIT Validation
The FDA revised the cGMP requirements for medical devices and incorporated them into a Quality System (QS) regulation. The QSIT is a system type approach to conducting comprehensive inspections of medical device manufacturers
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1999-03-01 |
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Evaluation of the Validation Status of Toxicological Methods: General Guidelines for Submissions to ICCVAM
The purpose of this document is to provide guidance to sponsors on the information needed by ICCVAM to evaluate the validation status of a proposed test method, NIH
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1999-01-10 |
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Bioanalytical Methods Validation for Human Studies
This guidance provides assistance in developing validation information for bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies, FDA
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1998-12-01 |
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Requesting Methods Validation for Abbreviated New Drug Applications (ANDAs)
To assist reviewers in defining when the Office of Generic Drugs (OGD) should request that analytical methods and testing procedures be validated by FDA laboratories when approving an ANDA, FDA
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1998-11-01 |
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Data Validation Standard Operating Procedures For Polychlorinated Dibenzodioxin and Polychlorinated Dibenzofurans Analysis by High Resolution Gas Chromatography/High Resolution Mass Spectrometry
The objective of this Standard Operating Procedure (SOP) is to assist in the technical review of polychlorinated dibenzodioxin and polychlorinated dibenzofuran (PCDD/PCDF) analytical data, US. EPA
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1998-10-01 |
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Medical Devices: Draft Global Harmonization Task Force Study Group 3 Process Validation
Guidance for the manufacture of medical devices, FDA
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1998-07-16 |
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General Principles of Software Validation Guidance for Industry
This draft guidance is intended as a general overview of software validation principles, and as a beginning point for use in evaluating software validation programs. FDA
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1997-06-09 |
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Validation and Regulatory Acceptance of Toxicological Test Methods
A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods, NIH
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1997-03-01 |
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FDA's Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
This guideline sets out acceptable conditions for use of the LAL test. It also describes procedures for using this methodology as an end-product endotoxin test for human and animal injectable drugs, and medical devices, FDA
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1997-01-01 |
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Guideline on the Validation of Analytical Procedures: Methodology
This document is complementary to the parent document which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. ICH
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1996-01-01 |
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Text on Validation of Analytical Procedures
This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan and the United States, ICH-Q2A
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1995-05-01 |
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Validation of Chromatographic Methods
The purpose of this technical review guide is to present the issues to consider when evaluating chromatographic test methods from a regulatory perspective, FDA
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1994-11-01 |
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Review Guidance Validation of Chromatographic Methods
The purpose of this technical review guide is to present the issues to consider when evaluating chromatographic test methods from a regulatory perspective. FDA
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1994-01-01 |
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Validation of Analytical Procedures: Definitions and Terminology*)
This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of applications submitted within the EC, Japan and USA. FDA
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1994-01-01 |
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Guideline on General Principles of Process Validation
This guideline outlines general principles that FDA consider to be acceptable elements of process validation for the preparation of human and animal drug products and medical devices, FDA
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1987-05-01 |
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Guideline for submitting samples and analytical data for methods validation
This guideline is intended to assist applicants in submitting samples and analytical data to the Food and Drug Administration (FDA) for methods evaluation, FDA
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1987-03-01 |
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Guide to Inspections Validation of Cleaning Processes
This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). This guide is intended to cover equipment cleaning for chemical residues only. FDA
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