GMP - Quality - Up
An Online Resource of Quality Assurance Procedures
  GMP Validation Guidance

  Method Validation

  Analytical Test Method Validation - General Guidence
  Analytical Test Method Validation - Risk Assessment and Prioritization
  Analytical Test Method Validation - System Suitability
  Analytical Test Method Validation - Precision and Accuracy
  Analytical Test Method Validation - Quantitation and Detection Limit
  Analytical Test Method Validation - Linearity, Range and Specificity
  Analytical Test Method Validation - Robustness

  Cleaning Validation
 
  Cleaning Validation -  Calculations of Residue Limits For Drug Products for Equipment Cleaning
  Cleaning Validation -  Product and Equipment Grouping and Worst - Case Product Selection
  Cleaning Validation – Rinsate and Swab Sample,Test Method Development and Validation
  Cleaning Validation – Visual Inspection and Quantitation
  Cleaning Verification – Investigating Unknown Peaks in Chromatography
  Cleaning Evaluation Documentation and Instruction - Records for Cleaning Activities
  Critical Process Parameters for Drug Product

  Other Validation

  Process Validation for Drug Products and Medical Devices
  Equipment Cleaning Validation For Active Pharmaceutical Ingredients
  Equivalence Criteria of Impurities for API Process Validation
  Equivalency Comparison of Drug Product Validation Batch Data to Reference Batches
  Establishing and Extending Clean Equipment Hold Times
  Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation of APIs and Drug Products
  Evaluation of Changes for Potential Impact on Process Validation
  General Guidance for Process Validation Sampling
  In-Process and Bulk Drug Product Holding Times
  Demonstration of Active Pharmaceutical Ingredient (API) Batch Homogeneity
  Documentation Example for Continuous Quality Verification
  Documentation to Support Continuous Quality Verification
  Guidance on Selection Criteria of Dose and Toxicity Data for Use in Cleaning Limit Calculation
  Inspection Attributes in Packaging Validation of Non-Sterile Drug  Products
  Laboratory Equipment Qualification
  Matrices and Bracketing in Process Validation
  Considerations for Selecting Packaging Lot Sizes during Packaging Validation and relevent Examples
  Non-Sterile Active Pharmaceutical Ingredient (API) Manufacturing Area Environmental Control
  Packaging Validation - Potential Critical Process Parameters and Validation Practices
  Process Validation Sampling for Non-Sterile LiquidSemi Solid Drug Products
  Process Validation Sampling for Non-Sterile Solid Dose Drug Products
  Performance Qualification versus Process Validation
  Periodic Review of Processes and Systems
  Release For Commercial Use of Drug Product and API Pre-Validation and Validation Batches
  Selection of Critical Process Parameters for Validation
  Semi-Solid Dosage Forms-Critical Process Parameters
  Solid Oral Dosage Forms-Potential Critical Process Parameters
  Solvent Recovery Validation Example
  Test Deviations during Validation
  Validation Activities during Technology Transfers 
  Validation Considerations for Re-work and Re-process of Active Pharmaceutical Ingredients (API)
  Validation Documentation
  Shipping Validation for Biopharmaceutical Materials Derived from Biotech Processes
  System Level Impact Assessment for Information Systems
  Clean Pure Steam System Commissioning and Qualification - Sampling Plans
  GMP Quality Guidance    

  Product Quality Complaint Handling
  Application of Quality Risk Management to Periodic Review of SOPs
  Statistical Rationale for Raw Material Sampling
  Quality Risk Management Application Critical Instrument Calibration
  Structured On-the-Job Training System
  Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
  Disposal of Rejected and Waste Materials
  Quality Assurance Self-Appraisals
  Material Status Indication
  Annual Product Records Review
  Receipt, Approval and Use of Labels and Labeling
  Weighing and Measuring Practices In Manufacturing Operations
  Material Supplier Approval
  Storage & Distribution of Drug Products, Medical Devices and Related Materials
  Control of Manufacturing and Packaging Defects Non Sterile
  Pest Control
  Raw Materials and Packaging Materials Receipt
  Sampling of Production Materials and Finished Goods
  Water Purification, Storage and Distribution For Pharmaceutical Production
  Use of a Risk-Based Approach To Establish External Quality Assurance Audit Frequency
  Reduced Testing Program
  GMP Training System
  Stability Testing
  Quality Risk Management Application to Identify Deviations vs. Events
  Implementation of Real Time Release
  Preventive Maintenance
  Calibration
  Evaluation Process Supporting Elimination of Defined Shipment Temperature Range
  Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers
  Quality Risk Management to Establishment of Weighing Device Performance Testing Intervals
  Analytical Laboratory Management
  Microbiology Laboratory Management
  Transfer of Analytical Methods
  Quality Agreements


  Aseptic Processing Area Guidance

  Alternatives to Formaldehyde Fogging of Clean Rooms
  Clean Steam Systems
  Cleaning and Sterilization of Aseptic Manufacturing Equipment
  Container Closure Integrity for Sterile Drug Products
  Controlling the Microbiological Quality of Solid Oral Dosage Forms
  Defining Worst Case Conditions for Aseptic Process Simulations
  Explanation of Repeat Testing and Retesting Utilized During Microbiological OOS Investigations
  Gamma Radiation Sterilization
  Lyophilization
  Lyophilizer Loading and Unloading Recommendations
  Microbial Attributes Testing of Non-Sterile Solid Oral Dosage Forms and Materials
  Microbiological Testing in Cleaning Validation for APIs and Drug Products
  Overview of Trending of Environmental Monitoring Data for Aseptic Processing Areas
  Packaging System Integrity for Sterile Medical Devices
  Preventing Cross Contamination
  Prevention and Control of Fungal Contamination in Tablets
  Sanitant Rotation in a Routine Sanitization Program
  Sterilization or Depyrogenation Validation - Non Product
  Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations for Aseptic Processing Areas
  Use of Sterilized Goggles Within the Aseptic Processing Area
  Water Activity - What Is It and How Does It Apply To Pharmaceutical Manufacturing

 
  Good Working Practice
 
  Good Practice - Facilities and Equipments

  Equipment Cleaning for Drug Products
  Identification of Equipment Areas and Processes
  Equipment Cleaning for Active Pharmaceutical Ingredients (APIs)
  Calibration
  Preventative Maintenance
  Cleaning and Sterilization of Aseptic Manufacturing Equipment
  Areas and Facilities Cleaning and Maintenance
  Pest Control
  Water Purification, Storage, and Distribution for Pharmaceutical Production
  Air Handling Systems & Air Classifications for Aseptic Operations
  Clean Steam Systems
  Aseptic Area Environmental Control

  Good Practice - Materials
 
  Reevaluation of Stored Materials
  Disposal of rejected and waste material
  Material Status Indication
  Material Supplier Approval
  Raw Materials and Packaging Materials - Receipt
  Sampling of Production Materials and Finished Goods
  Storage and Distribution of Drug Products, Medical Devices, and Related Materials
  Subdividing Dispensing & Transferring Materials to Production Areas
  Quarantine Shipment

  Good Practice - Labeling and Packaging

  Instructions for Filling, Labeling and Packaging Pharmaceutical Drug Products and API's for Commercial Purposes
  Creation, Revision, and Approval for Artwork Used on Packaging Components
  Receipt, Approval, and Use of Labels and Labeling
  Container Closure Integrity for Sterile Drug Products
  Packaging System Integrity for Sterile Medical Devices

  Good Practice - Operations
  Inspecting for Manufacturing and Packaging Defects-Aseptic
  Instructions for Manufacture of APIs and Drug Products
  Uniform Practices for Manufacturing Operations
  Personnel Qualification Program for Aseptic Processing Areas and Preparation for Aseptic Areas
  Aseptic Processing Facility Environmental Monitoring
  Use and Recovery of Solvents in API Manufacturing
  Metal Detection
  Weighing and Measuring Practices in Manufacturing Operations
  Gamma Radiation Sterilization
  Preventing Cross Contamination
  Control of Manufacturing and Packaging Defects Non-Sterile
  Sterilization/Depyrogenation Validation: Non-Product
  Gowning Practices for Aseptic Processing Areas and Preparation for Aseptic Areas
  Cleaning Depyrogenation and Sterilization of Containers and Closures
  Sterilizing Filters and Filtration Systems
  Moist Heat Terminal Sterilization of Aqueous Parenteral Products
  Media Fills for Sterile Drug Products and Aseptically Processed Medical Devices
  Batch and Lot Identification
  Aseptic Manufacturing Practices


  GMP|Manufacturing SOP|Quality Assurance (QA) Management|Compliance Management|Quality Control (QC) Laboratory|Microbiology Laboratory  
  (Sterility Testing)|Audit Training|Process, Cleaning, Method Validation|Quality and Validation Guidance | Good Working Practice | Standard Operating Procedures (SOP) for Pharmaceuticals
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