Pharmaceuticals Quality Assurance Procedures

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GMP Quality and Validation Guidance

Method Validation

Guidance 001 - Analytical Test Method Validation - General Guidance

Guidance 002 - Analytical Test Method Validation - Risk Assessment and Prioritization

Guidance 003 - Analytical Test Method Validation - System Suitability

Guidance 004 - Analytical Test Method Validation - Precision and Accuracy

Guidance 005 - Analytical Test Method Validation - Quantitation and Detection Limit

Guidance 006 - Analytical Test Method Validation - Linearity, Range and Specificity

Guidance 007 - Analytical Test Method Validation - Robustness

Cleaning Validation

Guidance 008 - Calculations of Residue Limits For Drug Products for Equipment Cleaning

Guidance 009 - Guidance for Swab Sampling and Visual Inspection Locations for API Equipment

Guidance 010 - Product and Equipment Grouping and Worst - Case Product Selection

Guidance 011 - Rinsate and Swab Sample,Test Method Development and Validation

Guidance 012 - Visual Inspection and Quantitation

Guidance 013 - Investigating Unknown Peaks in Chromatography

Guidance 014 - Cleaning Evaluation Documentation and Instruction - Records for Cleaning Activities

Other Validation

Guidance 015 - Critical Process Parameters for Drug Product

Guidance 016 - Identification of the Critical Steps for Drug Product Process

Guidance 017 - Process Validation for Drug Products and Medical Devices

Guidance 018 - Equipment Cleaning Validation For Active Pharmaceutical Ingredients

Guidance 019 - Equivalence Criteria of Impurities for API Process Validation

Guidance 020 - Equivalency Comparison of Drug Product Validation Batch Data to Reference Batches

Guidance 021 - Establishing and Extending Clean Equipment Hold Times

Guidance 022 - Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation of APIs & Drug

Products

Guidance 023 - Evaluation of Changes for Potential Impact on Process Validation

Guidance 024 - General Guidance for Process Validation Sampling

Guidance 025 - Guidance for Swab & Visual Inspection Sampling Locations for Drug Products Equipment

Guidance 026 - In-Process and Bulk Drug Product Holding Times

Guidance 027 - Demonstration of Active Pharmaceutical Ingredient (API) Batch Homogeneity

Guidance 028 - Documentation Example for Continuous Quality Verification

Guidance 029 - Documentation to Support Continuous Quality Verification

Guidance 030 - Guidance on Selection Criteria of Dose & Toxicity Data for Use in Cleaning Limit Calculation

Guidance 031 - Inspection Attributes in Packaging Validation of Non-Sterile Drug Products

Guidance 032 - Laboratory Equipment Qualification

Guidance 033 - Matrices and Bracketing in Process Validation

Guidance 034 - Considerations for Selecting Packaging Lot Sizes during Packaging Validation

Guidance 035 - Non-Sterile API Manufacturing Area Environmental Control

Guidance 036 - Packaging Validation - Potential Critical Process Parameters and Validation Practices

Guidance 037 - Process Validation Sampling for Non-Sterile LiquidSemi Solid Drug Products

Guidance 038 - Process Validation Sampling for Non-Sterile Solid Dose Drug Products

Guidance 039 - Performance Qualification versus Process Validation

Guidance 040 - Periodic Review of Processes and Systems

Guidance 041 - Release For Sale of Drug Product and API Pre-Validation & Validation Batches

Guidance 042 - Selection of Critical Process Parameters for Validation

Guidance 043 - Semi-Solid Dosage Forms-Critical Process Parameters

Guidance 044 - Solid Oral Dosage Forms-Potential Critical Process Parameters

Guidance 045 - Solvent Recovery Validation Example

Guidance 046 - Test Deviations during Validation

Guidance 047 - Validation Activities during Technology Transfers

Guidance 048 - Validation Considerations for Re-work and Re-process of API

Guidance 049 - Validation Documentation