GMP Guidance Summary
Guidance Summary 01 - 10
- 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
- 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 Summary 11 - 20
- 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
- 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 Summary 21 - 30
- 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 Summary 31 - 40
- 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 035 - Non-Sterile Active Pharmaceutical Ingredient Manufacturing Area
- Guidance 036 - Potential Critical Packaging Process Parameters and Validation Practices
- Guidance 037 - Process Validation Sampling for Non-Sterile Liquid, Semi Solid Drug Products
- Guidance 038 - Process Validation Sampling for Non-Sterile Solid Dose Drug Products
- Guidance 040 - Periodic Review of Processes and Systems
Guidance Summary 41 - 50
- Guidance 041 - Release For Commercial Use of Drug Product 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
- Guidance 050 - Shipping Validation for Biopharmaceutical Materials Derived from Biotech Processes
Guidance Summary 51 - 60
- Guidance 051 - System Level Impact Assessment for Information Systems
- Guidance 052 - Clean Pure Steam System Commissioning and Qualification - Sampling Plans
- Guidance 053 - Component Level Impact Assessment for Information System Application
- Guidance 054 - Cycle Validation for Freeze Drying
- Guidance 055 - Documenting IQ, OQ, PQ Protocol Test Results for Equipment, Facility and Computer
- Guidance 056 - Material of Construction (MOC) Documentation
- Guidance 057 - Packaging Process Documentation Transfer for Drug Products
- Guidance 058 - Purified Water and Water for Injection System Commissioning and Qualification Sampling
- Guidance 059 - Quality Considerations for Direct Impact Compressed Air and Nitrogen Systems
- Guidance 060 - Product Quality Complaint Handling
Guidance Summary 61 - 70
- Guidance 061 - Application of Quality Risk Management to Periodic Review of SOPs
- Guidance 062 - Statistical Rationale for Raw Material Sampling
- Guidance 063 - Quality Risk Management Application Critical Instrument Calibration
- Guidance 064 - Structured On-the-Job Training System
- Guidance 065 - raining system for Aseptic and Preparation for Aseptic Operators and Support Staff
- Guidance 066 - Disposal of Rejected and Waste Materials
- Guidance 067 - Quality Assurance Self-Appraisals
- Guidance 068 - Material Status Indication
- Guidance 069 - Annual Product Records Review
- Guidance 070 - Receipt, Approval and Use of Labels and Labeling
Guidance Summary 71 - 80
- Guidance 071 - Weighing and Measuring Practices in Manufacturing Operations
- Guidance 072 - Material Supplier Approval
- Guidance 073 - Storage & Distribution of Drug Products, Medical Devices and Related Materials
- Guidance 074 - Control of Manufacturing and Packaging Defects Non Sterile
- Guidance 075 - Pest Control
- Guidance 076 - Raw Materials and Packaging Materials Receipt
- Guidance 077 - Sampling of Production Materials and Finished Goods
- Guidance 078 - Water Purification, Storage and Distribution for Pharmaceutical Production
- Guidance 079 - Use of a Risk-Based Approach to Establish External Quality Assurance Audit Frequency
- Guidance 080 - Reduced Testing Program
Guidance Summary 81 - 90
- Guidance 081 - GMP Training System
- Guidance 082 - Stability Testing
- Guidance 083 - Quality Risk Management Application to Identify Deviations vs. Events
- Guidance 084 - Implementation of Real Time Release
- Guidance 085 - Preventive Maintenance
- Guidance 086 - Calibration
- Guidance 087 - Evaluation Process Supporting Elimination of Defined Shipment Temperature Range
- Guidance 088 - Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers
- Guidance 089 - Quality Risk Management to Establishment of Weighing Device Performance Testing Intervals
- Guidance 090 - Analytical Laboratory Management
Guidance Summary 91 - 100
- Guidance 091 - Microbiology Laboratory Management
- Guidance 092 - Transfer of Analytical Methods
- Guidance 093 - Quality Agreements with Third Party Manufacturer
- Guidance 094 - Systems Validation
- Guidance 095 - Metal Detection
- Guidance 096 - Hose Management
- Guidance 097 - Use of Process Analytical Technology in Process Validation
- Guidance 098 - Implementation of Process Analytical Technology
- Guidance 099 - Validation of Process Analytical Technology System
- Guidance 100 - Alternatives to Formaldehyde Fogging of Clean Rooms
Guidance Summary 101 - 110
- Guidance 101 - Clean Steam Systems
- Guidance 102 - Cleaning and Sterilization of Aseptic Manufacturing Equipment
- Guidance 103 - Container Closure Integrity for Sterile Drug Products
- Guidance 104 - Controlling the Microbiological Quality of Solid Oral Dosage Forms
- Guidance 105 - Defining Worst Case Conditions for Aseptic Process Simulations
- Guidance 106 - Explanation of Repeat Testing and Retesting Utilized During Microbiological OOS Investigations
- Guidance 107 - Gamma Radiation Sterilization
- Guidance 108 - Lyophilization
- Guidance 109 - Lyophilizer Loading and Unloading Recommendations
- Guidance 110 - Microbial Attributes Testing of Non-Sterile Solid Oral Dosage Forms and Materials
Guidance Summary 111 - 120
- Guidance 111 - Microbiological Testing in Cleaning Validation for APIs and Drug Products
- Guidance 112 - Overview of Trending of Environmental Monitoring Data for Aseptic Processing Areas
- Guidance 113 - Packaging System Integrity for Sterile Medical Devices
- Guidance 114 - Preventing Cross Contamination
- Guidance 115 - Prevention and Control of Fungal Contamination in Tablets
- Guidance 116 - Sanitant Rotation in a Routine Sanitization Program
- Guidance 117 - Sterilization or Depyrogenation Validation - Non Product
- Guidance 118 - Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations for Aseptic Processing Areas
- Guidance 119 - Use of Sterilized Goggles Within the Aseptic Processing Area
- Guidance 120 - Water Activity - What Is It and How Does it apply to Pharmaceutical Manufacturing
Guidance Summary 121 - 130
- Guidance 121 - Shipping Processes for Drug Products
- Guidance 122 - Cold Chain Management of Biopharmaceutical Materials
- Guidance 123 - Stability Considerations for API Process Changes
- Guidance 124 - External Vial Capping Operations
- Guidance 125 - Use and Recovery of Solvents
- Guidance 126 - Establishing Re-evaluation Intervals for API Intermediates
- Guidance 127 - Conversion to Animal Free or TSE Risk Free API Processing
- Guidance 128 - Filing Strategy for Specifications for Raw Materials used in API
- Guidance 129 - Labelling of APIs and API Intermediates
- Guidance 130 - Post Approval Equipment Changes to API Manufacturing Processes