Direct Links to important GMP Validation Guidelines

FDA Guidance for Industry: Q2A Validation of Analytical Procedures

This guideline identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation

FDA Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology

This Guideline extends the guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures.

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable1 medical devices.

ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology

This Guideline extends the guideline Q2A to include the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedures which are included as part of registration applications and describes the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures. The content of this guideline was previously included in two separate guidelines coded Q2A and Q2B, which were unified to the Q2(R1) guideline in November 2005.

PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics.

Process Validation Guidance

This process validation guidance is intended to assist manufacturers in understanding quality system requirements concerning process validation.The guidance is revised due to the changes in ISO 13485:2003.

FDA Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility

FDA, is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.

FDA Guidance for Industry: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs

This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212).

FDA Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000)

Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000)

APIC - Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants

This document is supposed to assist companies in the formulation of cleaning validation programmes

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