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
250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All written and updated by GMP experts. Check out sample previews. Access to exclusive content for an affordable fee.
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
250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All written and updated by GMP experts. Check out sample previews. Access to exclusive content for an affordable fee.
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
250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All written and updated by GMP experts. Check out sample previews. Access to exclusive content for an affordable fee.
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
250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents are included each month. All written and updated by GMP experts. Check out sample previews. Access to exclusive content for an affordable fee.