GMP Quality Assurance and Compliance Procedures
  QMS-005 How to Write Standard Operating Procedure
  QMS-010 All Documents - Classification, Definition and Approval Matrix
  QMS-015 GMP Quality Documentation Management and Change Control
  QMS-020 Documentation Rule for GMP Documents
  QMS-025 GMP Quality Documentation - Control, Tracking and Distribution
QMS-025 Appendix 1 - Instruction for Updating or Creating Electronic Quality Documents
  QMS-030 Preparation, Maintenance and Change Control of Master Documents
QMS-030 Appendix 2 - Flowchart for Distribution of Master Documents
  QMS-035 Pharmaceutical Deviation Report System
QMS-035 Appendix - Process Flow of Deviation Report
  QMS-040 Shelf Life of Product
  QMS-045 Vendor Selection and Evaluation Procedure
QMS-045 Appendix - Flowchart - Vendor Selection and Evaluation Process
  QMS-050 Vendor Certification Procedure
  QMS-055 Pharmaceutical Product Complaint Procedure
  QMS-060 Annual Product Review
  QMS-065 Manufacturing Rework Procedure
  QMS-070 Responsibility of Authorized Person
  QMS-075 Procedure for Product Identification and Traceability
  QMS-080 GMP Audit Procedures
  QMS-085 Example of Checklist for Batch Documentation
QMS-085 Flowchart - Batch Documentation
  QMS-090 Evaluation of Batch Documentation and Release for Sale
  QMS-095 GMP Training Procedure
  QMS-100 How to Write GMP Training Materials
  QMS-105 House Keeping Audit Procedure
  QMS-110 Management and Control of Contract Work
  QMS-115 Criteria for Sourcing of Raw Materials, Packaging Components & Imported Finished Goods
  QMS-120 Quality Concern Investigation Process
GMP - Quality - Up
An Online Resource of Quality Assurance Procedures
  Pharmaceutical Audit Training Manuals

  Audit - 01 Auditing Principles for GMP Audit
Audit 01 Figure 1 During the audit
  Audit - 02 Understanding Worldwide Regulatory Requirements
Audit 02 Figure 1 The European Union (EU)
  Audit - 03 Auditing a Personnel & Training System
  Audit - 04 Auditing a Deviation Management System
  Audit - 05 Auditing a Validation System
Audit 05 Figure 1 General Validation guidelines
  Audit - 06 Auditing a Change Management System
  Audit - 07 Auditing a Complaint System
  Audit - 08 Auditing a Documentation System
Figures - [Example of CORRECT way to correct errors]
[Example of INCORRECT way to correct errors]; Time; Non-applicable pages of information;
Signatures on Documents
  Audit - 09 Auditing a Calibration, Preventative Maintenance & Housekeeping System
  Audit - 10 Auditing Computerised Systems
  Audit - 11 Auditing Utilities System
Figures - Manometer; Diagram of an Air Handling System; HVAC system
Potential problems; Water Systems
  Audit - 12 Auditing Warehouse and Distribution System
  Audit - 13 Auditing Environmental Monitoring System
Figures - Pressure Differentials; Monitoring of Surfaces; Contact plate method & Slit-to-agar
method; Swab method & Centrifugal method; Sieve method
  Audit - 14 Auditing Microbiology and Sterility Testing Laboratory
  Audit - 15 Auditing an Analytical Quality & Stability Testing Laboratory
Figures - Out-of-trend (OOT) result; Precision and accuracy; Methods; High Pressure Liquid
Chromatography (HPLC); HPLC Instrument; HPLC Chromatogram; Gas chromatography
Gas chromatogram; Infrared spectroscopy; FTIR Spectrum; FTIR Spectrum; Mass
spectrometer; Dissolution Apparatus
  Audit - 16 Auditing a Material Handling System
Audit 16 Figure 1 Sampling/testing of materials
  Audit - 17 Auditing an Active API Manufacturer
Audit 17 Figure 1 Certificate of Analysis
  Audit - 18 Auditing Packaging Material Vendors
Figures - Gang-printed labeling; Molding; Diagram of Blow molding machine
Glass manufacturing; Printing; Label, carton, leaflet printing; Syringe Manufacture

  Microbiology Laboratory|Sterility Testing Procedures

  MICLAB-005 Entry Procedure for Sterile Filling Areas
  MICLAB-010 Validation of Aseptic Gowning Procedures
  MICLAB-015 Microbiological Data Recording Procedure
  MICLAB-020 Destruction of Biological Waste in Microbiology Laboratory
  MICLAB-025 Depyrogenation of Glassware in Microbiology Laboratory Oven
  MICLAB-030 Media Preparation in Microbiology Laboratory
  MICLAB-035 Aseptic Media Filling and Microbiology Integrity Leak (Soup) Testing Procedure
  MICLAB-040 Aseptic Media Filling and Soup Test Guideline
  MICLAB-045 Environmental and Plant Hygiene Monitoring Procedure
  MICLAB 050 Microbial Limit Testing Procedure by Using Laminar Flow Cabinets.
  MICLAB-055 Microbiological Monitoring of Plant Water Systems
  MICLAB-060 Micro Laboratory Procedure for Sterility Testing
MICLAB-060 Appendix 1 - Flowchart of Sterility Test results - Interpretation and retest
  MICLAB-065 Determination of Heat Resistance of Spore Forming Organisms
  MICLAB-070 Identification of Microorganisms to Genus and Species Level
Figure 1: Plate Streaking for Single Colonies
Figure 2: The Gram Stain
Figure 3: Positive KOH Test
Figure 4: Catalase Reactions
Figure 5: The Coagulase Test
Figure 6: Form, Elevation and Margin of Colonies
Figure 7: Cellular Arrangements
Figure 8: Gram Stain of Staphylococcus cells
Figure 09: Gram Stain of Micrococcus cells
Figure 10: Gram Stain of Streptococcus cells
Figure 11: Gram Stain of Bacillus cells
Figure 12: Gram Stain of Clostridium cells
Figure 13: Gram Stain of Lactobacillus cells
Figure 14: Gram Stain of Corynebacterium Cells
Figure 15: Gram Stain of Acinetobacter cells
Figure 16: Gram Stain of Pseudomonas cells
Figure 17: Gram Stain of Escherichia coli cells
  MICLAB-075 Micro Evaluation on Bioburden, Non sterile and Raw Materials
  MICLAB-080 Bacterial EndoToxin Testing (LAL) - Gel Clot Metho
MICLAB-080 Figure - Gel-Clot Procedural Flowchart
  MICLAB-085 Bacterial EndoToxin Testing kCA Method
MICLAB-085 Figure - Preparation of Standards
  MICLAB-090 Stock Suspensions of Micro Organisms
MICLAB-090 Figures - Solid Growth Media; Diagram for streaking solid media
Appendix: Kwik-Stik instruction diagram
  MICLAB-095 Sterile Sampling Procedure for Microbiology Laboratory
  MICLAB 100 Microbiological Testing of Compressed Gasses
  MICLAB-105 Gel Clot Validation Method
  MICLAB-110 Laboratory Investigation and Retest Procedure for Atypical and Out of Specification Results
  MICLAB-115 Operation and Calibration of Sievers 820 TOC Analyser
  MICLAB 120 IPA Contamination Testing Procedure
Figure 1 - Failed Sample
Figure 2 - Passed sample


  GMP Manufacturing Procedures for Tablet Packing

  MAN-005 Clothing Requirements Inside the Factory Area
  MAN-010 Cleaning Responsibilities and Methods for Employees
  MAN-015 Factory Cleaning Procedure
  MAN-020 Manufacturing Pest Control Procedure
  MAN-025 Tours of Factory
  MAN-030 Management of Production Logbook
  MAN-035 Examples of Packaging Configuration for Production Line
  MAN-045 Checking Requirements of Components Prior to Use
  MAN-050 Safety Tag Out Procedure
  MAN-055 Procedures for Line Clearance, Line Opening and Line Cleaning
  MAN-060 Reconciliation Procedure of Component and Product
  MAN-065 Example-Operation of Barcode Reader
  MAN-070 Example-IBC Operation and Cleaning
MAN-070 Picture of an IBC
  MAN-075 Example of a Tablet Packing Machine -Construction, Operation and Cleaning
MAN-075 Figure 1 Construction of a tablet packing machine
MAN-075 Figure 2 Vision Camera System Challenge
  MAN-080 Example of Manufacturing Instruction for Tablet Packing
  MAN-085 Mop Cleaning Procedure
  MAN-090 Scheduling of Production Lines
MAN-090 Figure: Forecasting Cycle Overview
  MAN-095 Vacuum Leak Testing Procedure forFinished Goods
MAN-095 Figure - Vacuum Leak Test Apparatus
  MAN-100 Weighing Equipment - Checking and Calibration
  MAN-110 Example of Operation of automatic Checkweigher for Finished Packs
  MAN-115 Machine Start up Challenges and In-Process Testing Procedures
MAN-115 Vision Camera System Challenge; Blister Appearance and Correct Information
Check; Carton Coding Appearance and Correct Information; Some Examples of Opening
Components for Tablet Packing Line
  MAN-120 inished Pack Sampling by Production Personnel


  GMP Manufacturing & Quality Assurance Manuals

  Manual - 001 Evaluation of Contaminant Options for Packing of Solid Dosage Forms
  Manual - 002 Retention and Disposal of GMP Documents and Retention Samples
Manual 002 Appendix 1
  Manual - 003 Certificate of Materials Supplied to Receiving Manufacturing Site
  Manual - 004 Quality Assurance Agreements
  Manual - 005 Procedure for Quality Assurance Management of Contractors
Manual 005 Appendix 1 Guidance on the process for contractor selection
  Manual - 006 Guidelines for Regulatory Inspections
  Manual - 007 Quality and Compliance Auditing
  Manual - 008 Facility Based R&D Quality Assurance Audit
  Manual - 009 Auditor Training
  Manual - 010 GMP Compliance Improvements Plans
  Manual - 011 Archiving, Disposal and Record Management
  Manual - 012 Internal Quality Assurance Agreements
  Manual - 013 Audit of a Distribution Site
  Manual - 014 Supplier Auditing
Manual 014 5.9 Audit Reporing ; 5.12 Audit Standards
  Manual - 015 Management of Master GMP Document
  Manual - 016 Artwork Creation & Control of Printed Packaging Components
  Manual - 017 Release of API Bulk Formulated Products & Part Finished Packs
  Manual - 018 Computerized Systems Risk Management
  Manual - 019 Batch Confirmation Certification & Release by a Qualified Person within the EU
Manual 019
Appendix 1. Flow sheet: When all manufacture occurs at a single authorized site
Appendix 2. Flow sheet: Different stages of manufacture are conducted at different sites
  Manual - 020 Cross Contamination Risk Evaluation Process for Commercial Compounds
Manual 020 Figure 5.3 Contents of an evaluation request
  Manual - 021 Certificate of Analysis & Certificate of Manufacture
Appendix Schematic showing production and distribution of batch specific documentation
  Manual - 022 Pharmaceutical Product Reviews
Manual 022 5.4 Content of the Product Review Report
  Manual - 023 Warehousing and Distribution of Commercial Products
  Manual - 024 Utility Standards
  Manual - 025 Conducting Investigations
Manual 025 Figure - Recommended process for conducting investigation
  Manual - 026 Management and Documentation of Training
  Manual - 027 Definition and Documentation of Raw Data
  Manual - 028 Risk Management in the Quality Assurance and Compliance Area
Manual 028 Figure 1 Generic Framework for Quality Risk Management Process
  Manual - 029 Manufacturing Deviation Management
Manual 029
5.1.1 Deviation Reporting
6.1 Appendix 1 Deviation Reporting Minimum Responsibilities
6.2 Appendix 2 Deviation Lifecycle
6.3 Appendix 3 Systematic Process Scheme
Prioritization tool : 4-Box model

  Manual - 30 Study Based GLP Quality Assurance Audit for Critical Phases
  Manual - 31 Guideline for Development and Contents of Specifications
Manual 031
6.1.2 Bulk Drug Substance (API)
6.1.2.2 Organic Impurities: Figure1
6.1.2.2 Organic Impurities: Figure 2
6.1.2.6 Assay
6.1.2 Tablets and Capsules (immediate release (IR) and extended release (ER)),
Oral powders and granules, Oral solutions and suspensions (unit dose)
6.1.4 Placebo (for tablets etc)
6.1.5 Parenteral solution (Single Dose Containers)
6.1.6 Placebo (for parenteral solution)
  Manual - 32 R&D QA Audits for Suppliers and Vendors
  Manual - 33 Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance
  Manual - 34 Determination of Storage Periods for APIs Excipients Intermediates and Raw Materials
  Manual - 35 The Preparation of Process Validation Master Plan
Manual 035 6.1 Appendix 1: Validation Master Plan
  Manual - 36 Process Validation of Bulk Drug (API and Intermediate)
Figure - API and Intermediate Sampling and Testing.
  Manual - 37 Process Validation for Formulated Products
  Manual - 38 Cleaning and Cleaning Validation of API Plant and Equipment
Manual 038 Appendix 1 Product Changeovers and Risk Levels
  Manual - 39 Sterilization Process Validation
  Manual - 40 Cleaning and Cleaning Validation For Formulated Products
  Manual - 41 Analytical Laboratory Procedure Validation
  Manual - 42 Water Quality Standard
  Manual - 43 Sterility Testing Procedure
  Manual - 44 Endotoxin Testing Procedure
  Manual - 45 Guideline for Stability Testing for R&D
Manual 045 Appendices
  Manual - 46 Storage and Expiry Dating of Analytical Reagents in Laboratory
  Manual - 47 Preparation & Maintenance of Stability Protocols and Stability Master Plans
Manual 047 5.2.4 Schedules
  Manual - 48 Commercial Stability Testing of API (Pure Bulk Drug)
Manual 048
5.2.2 Testing Schedules
5.3.2 Testing Schedules
  Manual - 49 Commercial Stability Studies at Contractors
  Manual - 50 R&D Laboratory Quality Assurance Record Retention Procedure
  Manual - 51 Microbiological Testing for Non Sterile Drug Product
Manual 051 5.2.3 Routine Analysis and Suggested Acceptance Criteria, Table I
  Manual - 52 Reference & Retention Samples
Manual 052
6.1 Appendix A Reference Samples
6.2 Appendix B Retention Samples
  Manual - 53 Laboratory Equipment Qualification
Manual 053
5.1 Qualification
5.4.2 Level of Qualification
  Manual - 54 Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
Manual 054 6 Appendices
  Manual - 55 Commercial Stability Testing  For Formulated Products
Manual 055
5.2.3.1 Solid Dosage Forms
5.2.3.2 Liquids and Semi-solids
5.2.3.3 Bulk Package Stability
5.3.3.1 Solid Dosage Forms
5.3.3.2 Liquids and Semi-solids
5.5.3 Schedule
  Manual - 56 Environmental Monitoring
Manual 056 6. Appendices
  Manual - 57 Trending of Stability Data
Manual 057
6.1 Appendix 1 Examples of Atypical Results
6.2 Appendix 2 Atypical Result investigation
6.3 Appendix 3 Examples of Atypical and Adverse Trends
6.4 Appendix 4 Atypical Trend Investigation
  Manual - 58 Laboratory Out of Specification Results Investigation
Manual 058 Appendix A: Handling of OOS Results
  Manual - 59 Manufacturing Documentation
  Manual - 60 Maintenance and Calibration of GMP Critical Items in Manufacturing Operations and R&D
  Manual - 61 Retreatment and Blending of API & Formulated Product
  Manual - 62 In-Process Testing, Checks and Sampling
  Manual - 63 Management of Returned Goods
  Manual - 64 Receipt Handling and Storage of Starting & Packaging Materials
  Manual - 65 Control of Packaging Operation
  Manual - 66 Requirements of Facilities For Sterile and Non-sterile  Drug Manufacturing
Manual 066 Appendices
  Manual - 67 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
  Manual - 68 Principles and Responsibilities for The Management of Change in Manufacturing Operations
  Manual - 69 The Validation of Facilities and Systems
  Manual - 70 Information Technology Infrastructure Qualification
  Manual - 71 Management of Change in Computerised System
  Manual - 72 Access by Regulatory Authorities and Auditors to Electronic Records
  Manual - 73 Guidelines for Generating Manufacturing Documentations
  Manual - 74 Electronic Records and Electronic Signatures
  Manual - 75 Retreatment and Blending of API and Formulated Products 
  Manual - 76 Out of Specifications Results Investigation Procedure
  Manual - 77 Analytical Procedures and Validation
  Manual - 78 Technology Transfer of Established Medicine from One Commercial Site to Other

  Pharmaceutical Process/Cleaning/Method/Computer Validation

  VAL-005 Validation - Concept and Procedure
  VAL-010 Revalidation Procedure
  VAL-015 Method Validation Procedure
  VAL-020 Procedure for Cleaning Validation
  VAL-025 Validation of Laboratory Instruments
  VAL-030 Equipment Specification and Qualification
  VAL-035 In-House Trial Procedure
  VAL-040 Computer System Validation
  VAL-045 Impact Assessment for Computerised Systems
  VAL-050 Functional Testing Guide for Computerised System
  VAL-055 Design Qualification Guidelines
  VAL-060 Protecting Reliability of Electronic GMP Documents
 
  TEMPLATE-010 Cleaning Validation-Rinsing Test Template
  TEMPLATE-015 Cleaning Validation-Swab Test Template
  TEMPLATE-020 Cleaning Validation-Comparative Analysis Template
  TEMPLATE-025 Example of Installation Qualification Report
  TEMPLATE-030 Example of Operational Qualification Report
  TEMPLATE-035 Example of Operational Qualification Test Protocol
  TEMPLATE-040 Example of Performance Qualification Test Protocol
  TEMPLATE-045 Example Product Quality Risk assessment
  TEMPLATE-050 Example Validation File Index
  TEMPLATE-055 Example of Validation Plan
  TEMPLATE-060 Example of Validation Report
  TEMPLATE-065 Example EHS Audit Report
  TEMPLATE-070 Example of User Requirement Specification
  TEMPLATE-160 Example of Commissioning Plan
  TEMPLATE-165 Example of Design Qualification Protocol
  TEMPLATE-170 Example of Installation Qualification Equipment
  TEMPLATE-175 Example of Installation Qualification HVAC
  TEMPLATE-180 Example of Installation Qualification Operating Environment
  TEMPLATE-185 Example of Installation Qualification Pipework
  TEMPLATE-190 Example of Installation Qualification Utilities
  TEMPLATE-195 Example of Electrical Demand Specification
  TEMPLATE-200 Example of Instrumentation Demand Specification
  TEMPLATE-205 Example of Mechanical Demand Specification
  TEMPLATE-210 Example of HAZOP Report
  TEMPLATE-215 Example of Traceability Matrix Report
  TEMPLATE-220 Example of Validation Discrepancy Form
  TEMPLATE-225 Example of Validation Report Combined OQ_PQ
  TEMPLATE-230 Example of  Project Definition Report
  TEMPLATE-235 Example of Project Evaluation and Closeout Report
  TEMPLATE-240 Example of Test Protocol Change Request Form
  TEMPLATE-245 Example of Installation Qualification Computer
  TEMPLATE-250 Cleaning Validation Interim Report Template
  TEMPLATE-255 Cleaning Validation Campaign Length Increase Protocol
  TEMPLATE-260 Cleaning Validation Protocol Template
  TEMPLATE-265 Cleaning Validation Report Template
  TEMPLATE-270 Installation and Operational Qualification Protocol Template
  TEMPLATE-275 Installation and Operational Qualification Report Template
  TEMPLATE-280 Packaging Validation Protocol Template
  TEMPLATE-285 Packaging Validation Report Template
  TEMPLATE-290 Process Validation Protocol template
  TEMPLATE-295 Process Validation Report Template
  TEMPLATE-300 Product Transfer Protocol Template
  TEMPLATE-305 Electronic Records and Signatures Compliance Assessment
  TEMPLATE-310 Impact Assessment Template for Equipment, Utility and Computer

  GMP 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 medicinal 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
  Guidance 050 - Shipping Validation for Biopharmaceutical Materials Derived from Biotech Processes
  Guidance 051 - System Level Impact Assessment for Information Systems
  Guidance 052 - Clean Pure Steam System Commissioning and Qualification - Sampling Plans
 
  GMP Quality Guidance

  Guidance 060 - Product Quality Complaint Management
  Guidance 061 - Quality Risk Management for Periodic Review of standard operating procedures
  Guidance 062 - Statistical Rationale and criteria for Raw Material Sampling
  Guidance 063 - Quality Risk Management for Critical Instrument Calibration
  Guidance 064 - Structured On-the-Job and gmp Training System
  Guidance 065 - Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
  Guidance 066 - Disposal of Rejected and Waste Materials
  Guidance 067 - Quality Assurance Audit
  Guidance 068 - Inventory Traceability and Status Indication
  Guidance 069 - Annual Product Review Guideline
  Guidance 070 - Receipt, Approval and Use of Labels and Labeling Operation
  Guidance 071 - Weighing and Measuring Practices In Manufacturing Operations
  Guidance 072 - Approval of Material Supplier
  Guidance 073 - Storage & Distribution of Drug Products, Medical Devices and Related Materials
  Guidance 074 - Control of Manufacturing and Packaging Defects for Non Sterile Products
  Guidance 075 - Pest Control Procedure
  Guidance 076 - Raw Materials and Packaging Materials Receipt Guidance
  Guidance 077 - Sampling of Production Materials and Finished Goods Practicces
  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 081 - GMP Training System
  Guidance 082 - Stability Testing Methodology
  Guidance 083 - Quality Risk Management Application to Identify Deviations and Events
  Guidance 084 - Approach and Implementation of Real Time Release
  Guidance 085 - Preventive Maintenance
  Guidance 086 - Calibration of Equipments
  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 091 - Microbiology Laboratory Management
  Guidance 092 - Transfer of Analytical Methods
  Guidance 093 - Quality Agreements

 
  Aseptic Processing Area Guidance

  Guidance 100 - Alternatives to Formaldehyde Fogging of Clean Rooms
  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 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

 
  Industry Practice
 
  Practice 01

  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

  Practice 02
 
  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

  Practice 03

  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

  Practice 04

  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

All documents are password protected. Please login by using the ID and password provided to open a document. To get an ID and password please read more about easy subscription with gmp-quality-up by clicking the subscribe button on the left. Please use MicroSoft Internet Explorer for browsing.