Direct Links to important GMP Validation Guidelines

Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES

Approaches to reduce impurities of the residual host DNA and host cell proteins in biotevchnical products during the downstrean process

Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS

This document describes methods to select and validate commercial qualitative immunoassay test kits for assessing contamination of plasma pools with antibodies to HIV 1 and 2 based on the above mentioned documents.

Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS

This document describes methods to select and validate commercial qualitative immunoassay test kits for assessing contamination of plasma pools with HBsAg

Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS

The purpose of this document is to provide scientific guidance relating to the viral safety of biotechnological medicinal products used in clinical trials. Guidance is provided with respect to: (i) the criteria for and the extent of viral safety evaluation studies, especially validation studies, that are required prior to and during clinical development. (ii) the extent to which manufacturers are able to refer to in-house experience concerning virus safety evaluation. (iii) the risk assessment which should form part of the safety evaluation.

Eudralex Volume 3 NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES

the guidance concerns the validation of virus inactivation and/or removal prcedures for all categories of medicinal biological products for human use with the exception of live virel vaccines including genetically engineerd live vectors.

FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE

This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS). The BECS that is incorporated into a Blood Establishment Computer System may be manufactured either in-house or by a software manufacturer/vendor.

FDA Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

This document is intended to provide guidance for the submission of information and data in support of the efficacy of sterilization processes in drug applications for both human and veterinary drugs

FDA Guidance for Industry: Process Validation: General Principles and Practices

This guidance outlines the general principles and approaches that FDA considers to be 21 appropriate elements of process validation for the manufacture of human and animal drug and 22 biological products, including active pharmaceutical ingredients (API or drug substance),

Eudralex Volume 3 Validation of Analytical Procedures: Text and Methodology (ICH Q2) CPMP/ICH/381/95 - ICH Q2 (R1)

Guideline on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for News Submissions and Variations

This guideline is intended to provide guidance in the process of calibration, validation and maintenance of a Near Infrared Spectroscopy (NIRS) method and the type of data to be submitted to the competent authorities in the case that NIRS is subject or part of an application.

Page 4 of 6