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-030 Preparation, Maintenance and Change Control of Master Documents
QMS-035 Pharmaceutical Deviation Report System
QMS-040 Shelf Life of Product
QMS-045 Vendor Selection and Evaluation Procedure
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-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
QMS-125 Change Management System
QMS-130 Cross Functional Investigation
QMS-135 Quality Risk Management Techniques

Quality Assurance Templates

TEMPLATE-005
TEMPLATE-080
TEMPLATE-085
TEMPLATE-090
TEMPLATE-095
TEMPLATE-100
TEMPLATE-105
TEMPLATE-110
TEMPLATE-115
TEMPLATE-120
TEMPLATE-125
TEMPLATE-130
TEMPLATE-135
TEMPLATE-140
TEMPLATE-145
TEMPLATE-150
TEMPLATE-155

Raw Material Specification and Test Report Template

Internal Audit Report Template
Training Report Template
Form Template
SOP Template
Quality Assurance Agreement Template
Third Party Manufacture Dispatch Report Template
In-House Manual Template
Protocol Rework- Manufactured Finished Goods
Vendor Audit Report Template
Protocol Rework- In Process Manufactured Goods
Position Paper Template
Control Method Template
Formulation Template
Finished Product Specification and Test Report Template
Packaging Material Specification and Test Report
Bill of Materials Template

Pharmaceutical Audit Training Manuals

Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit
Audit

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Auditing Principles for GMP Audit

Understanding Worldwide Regulatory Requirements
Auditing a Personnel & Training System
Auditing a Deviation Management System
Auditing a Validation System
Auditing a Change Management System
Auditing a Complaint System
Auditing a Documentation System
Auditing a Calibration, Preventative Maintenance & Housekeeping System
Auditing Computerised Systems
Auditing Utilities System
Auditing Warehouse and Distribution System
Auditing Environmental Monitoring System
Auditing Microbiology and Sterility Testing Laboratory
Auditing an Analytical Quality & Stability Testing Laboratory
Auditing a Material Handling System
Auditing an Active API Manufacturer
Auditing Packaging Material Vendors
Auditing a Packaging and Labeling Operation
Auditing an Aseptic Sterile Area
Auditing an Excipient Supplier
Auditing an Oral Solid Solution Area

Pharmaceutical Process/Cleaning/Method/Computer Validation

Procedures
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
VAL-065 Cleaning, Derouging and Passivation of the Stainless Steel Parts of the Purified
Water System
VAL-070 Cleaning Validation Analytical Methods
VAL-075 Validation Deviation Management
VAL-080 Validation Master Plan
VAL-085 Process Validation Guideline
VAL-090 Equipment Validation Guideline
VAL-095 Facility and Utility Validation Guideline
VAL-100 Process Validation Sampling
VAL-105 Raw Material Evaluation Process
VAL-110 Computer Validation Guideline
VAL-115 Process Validation for Liquid and Solid Dosage Manufacturing
VAL-120 Cleaning Validation Guideline
VAL-125 Guideline for the development of a Validation Project Plan
VAL-130 Guideline For The Development of A Computer Validation Project Plan
VAL-135 Risk Assessment for Computer Validation Systems

VAL-140
VAL-145
VAL-150
VAL-155
VAL-160
VAL-165

Development of a User and Functional Requirement Specification

Development of A Functional Requirement Specification for Computer Systems
Conducting an Electronic Record and Signature Assessment
Handling of Material Used for Trials
Periodic Review of Systems and Processes
Packaging Trials

Validation Templates
TEMPLATE-010
TEMPLATE-015
TEMPLATE-020
TEMPLATE-025
TEMPLATE-030
TEMPLATE-035
TEMPLATE-040
TEMPLATE-045
TEMPLATE-050
TEMPLATE-055
TEMPLATE-060
TEMPLATE-065
TEMPLATE-070
TEMPLATE-160
TEMPLATE-165
TEMPLATE-170
TEMPLATE-175
TEMPLATE-180
TEMPLATE-185
TEMPLATE-190
TEMPLATE-195
TEMPLATE-200
TEMPLATE-205
TEMPLATE-210
TEMPLATE-215
TEMPLATE-220
TEMPLATE-225
TEMPLATE-230
TEMPLATE-235
TEMPLATE-240
TEMPLATE-245
TEMPLATE-250
TEMPLATE-255
TEMPLATE-260
TEMPLATE-265
TEMPLATE-270
TEMPLATE-275
TEMPLATE-280
TEMPLATE-285
TEMPLATE-290
TEMPLATE-295
TEMPLATE-300
TEMPLATE-305
TEMPLATE-310

Cleaning Validation-Rinsing Test Template

Cleaning Validation-Swab Test Template
Cleaning Validation-Comparative Analysis Template
Example of Installation Qualification Report
Example of Operational Qualification Report
Example of Operational Qualification Test Protocol
Example of Performance Qualification Test Protocol
Example Product Quality Risk assessment
Example Validation File Index
Example of Validation Plan
Example of Validation Report
Example EHS Audit Report
Example of User Requirement Specification
Example of Commissioning Plan
Example of Design Qualification Protocol
Example of Installation Qualification Equipment
Example of Installation Qualification HVAC
Example of Installation Qualification Operating Environment
Example of Installation Qualification Pipework
Example of Installation Qualification Utilities
Example of Electrical Demand Specification
Example of Instrumentation Demand Specification
Example of Mechanical Demand Specification
Example of HAZOP Report
Example of Traceability Matrix Report
Example of Validation Discrepancy Form
Example of Validation Report Combined OQ_PQ
Example of Project Definition Report
Example of Project Evaluation and Closeout Report
Example of Test Protocol Change Request Form
Example of Installation Qualification Computer
Cleaning Validation Interim Report Template
Cleaning Validation Campaign Length Increase Protocol
Cleaning Validation Protocol Template
Cleaning Validation Report Template
Installation and Operational Qualification Protocol Template
Installation and Operational Qualification Report Template
Packaging Validation Protocol Template
Packaging Validation Report Template
Process Validation Protocol template
Process Validation Report Template
Product Transfer Protocol Template
Electronic Records and Signatures Compliance Assessment
Impact Assessment Template for Equipment, Utility and Computer

Quality Control Analytical Laboratory Procedures

LAB-005
LAB-010
LAB-015
LAB-020
LAB-025
LAB-030
LAB-035
LAB-040
LAB-045
LAB-050
LAB-055
LAB-060
LAB-065
LAB-070
LAB-075
LAB-080
LAB-085
LAB-090
LAB-095
LAB-100
LAB-105
LAB-110
LAB-115
LAB-120
LAB-125
LAB-130
LAB-135

Retest Dating of Raw Materials

Calibration Policies for Laboratory Instruments
Archiving Laboratory Documentation
Management of Reference Substances
Laboratory Workbook
Creation of Certificate of Analysis
Managing Analytical Reagents
Laboratory Waste Management
Retention Samples Management in Laboratory
Laboratory Supplier Approval
Laboratory Results Out of Specification Investigation
Laboratory Testing and Documentation of Raw Materials
Laboratory Testing and Documentation of Finished Products
Preparation and Maintenance of Stability Protocols for pharmaceuticals Products
Stability and Trial Testing Procedure for pharmaceuticals Products
Preparation of Disinfactant solution IPA
Laboratory Analytical Determinations
HPLC Reproducibility, Column Performance and Testing Guidelines
HPLC Method Development & Validation Procedure
Laboratory In Process and Finished Product Quality Control
Laboratory Housekeeping and Glassware Cleaning
Safety Procedure in Laboratory
Use and Control of laboratory Chemical Materials
Qualification of Laboratory Instruments
Sampling of Raw Materials, In-process and Bulk Finished Product
Stability Management Procedure
Validation of Analytical Test Procedure

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-065 Determination of Heat Resistance of Spore Forming Organisms
MICLAB-070 Identification of Microorganisms to Genus and Species Level
MICLAB-075 Micro Evaluation on Bioburden, Non sterile and Raw Materials
MICLAB-080 Bacterial EndoToxin Testing (LAL) - Gel Clot Metho
MICLAB-085 Bacterial EndoToxin Testing kCA Method
MICLAB-090 Stock Suspensions of Micro Organisms
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
MICLAB-125 Control of Microbiology Test Methods
MICLAB-130 Handling of Test Sample in Microbiology Laboratory
MICLAB-135 Documentation Requirement For Micro Test Method Validation
MICLAB-140 Maintenance of Culture Collection

Standard Operating Procedure for Packaging Operation

MAN-005
MAN-010
MAN-015
MAN-020
MAN-025
MAN-030
MAN-035
MAN-045
MAN-050
MAN-055
MAN-060
MAN-065
MAN-070
MAN-075
MAN-080
MAN-085
MAN-090
MAN-095
MAN-100
MAN-110
MAN-115
MAN-120
MAN-125

Clothing Requirements Inside the Factory Area

Cleaning Responsibilities and Methods for Employees
Factory Cleaning Procedure
Manufacturing Pest Control Procedure
Tours of Factory
Management of Production Logbook
Examples of Packaging Configuration for Production Line
Checking Requirements of Components Prior to Use
Safety Tag Out Procedure
Procedures for Line Clearance, Line Opening and Line Cleaning
Reconciliation Procedure of Component and Product
Example-Operation of Barcode Reader
Example-IBC Operation and Cleaning
Example of a Tablet Packing Machine -Construction, Operation and Cleaning
Example of Manufacturing Instruction for Tablet Packing
Mop Cleaning Procedure
Scheduling of Production Lines
Vacuum Leak Testing Procedure forFinished Goods
Weighing Equipment - Checking and Calibration
Example of Operation of automatic Checkweigher for Finished Packs
Machine Start up Challenges and In-Process Testing Procedures
Finished Pack Sampling by Production Personnel
Component Return Procedure From Packaging Floor

Warehouse Management Procedures

PUR-005 Material Purchasing Information Record and Source List
PUR-010 Generation of Purchase Order For Inventory and Consumables
WAR-005 Procedure for Receipt of Incoming Goods
WAR-010 Incoming Raw Materials and Components-Handling by QC Sampler
WAR-015 Warehouse Processing Issues, Returns and Rejects
WAR-020 Dispatch of Goods From Warehouse
WAR-025 Warehouse Inventory Management Procedure
WAR-030 Design of Warehouse Locations and Storage Area
WAR-040 Finished Goods Transfer to Quarantine and Distribution Warehouse
WAR-045 Sampling Procedure of Raw Materials
WAR-050 Sampling of Components and Printed Materials
WAR-055 Work in Progress Area
WAR-060 Safety Procedure of Warehouse Racking
WAR-065 Forklift Operation in Warehouse
WAR-075 Example of Tablet Dispensary Procedure
WAR-080 Example of Tablet Sampling Procedure as Raw Material

Environmental Health and Safety Procedures

EHS-005
EHS-010
EHS-015
EHS-020
EHS-025
EHS-030

Hazardous Chemical Substance Management

Environmental, Health and Safety Risk Management
Waste Removal Process
Identifying EHS Issues
EHS Incident Management Procedure
First Aid Procedure

GMP Manuals - Manufacturing & Quality Assurance Manuals

Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual EU
Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Manual Materials
Manual Manual Manual Manual -

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010
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015
016
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019

Evaluation of Contaminant Options for Packing of Solid Dosage Forms

Retention and Disposal of GMP Documents and Retention Samples
Certificate of Materials Supplied to Receiving Manufacturing Site
Quality Assurance Agreements
Procedure for Quality Assurance Management of Contractors
Guidelines for Regulatory Inspections
Quality and Compliance Auditing
Auditor Training
Facility Based R&D QA Audit
GMP Compliance Improvements Plans
Archiving, Disposal and Record Management
Internal Quality Assurance Agreements
Audit of a Distribution Site
Supplier Auditing
Management of Master GMP Document
Artwork Creation & Control of Printed Packaging Components
Release of API Bulk Formulated Products & Part Finished Packs
Computerized Systems Risk Management
Batch Confirmation Certification & Release by a Qualified Person within the

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021
022
023
024
025
026
027
028
029
030
031
032
033
034

Cross Contamination Risk Evaluation Process for Commercial Compounds

Certificate of Analysis & Certificate of Manufacture
Pharmaceutical Product Reviews
Warehousing and Distribution of Commercial Products
Utility Standards
Conducting Investigations
Management and Documentation of Training
Definition and Documentation of Raw Data
Risk Management in the Quality Assurance and Compliance Area
Manufacturing Deviation Management
Study Based GLP Quality Assurance Audit for Critical Phases
Guideline for Development and Contents of Specifications
R&D QA Audits for Suppliers and Vendors
Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance
Determination of Storage Periods for APIs Excipients Intermediates and Raw

035
036
037
038

The Preparation of Process Validation Master Plan

Process Validation of Bulk Drug (API and Intermediate)
Process Validation for Formulated Products
Cleaning and Cleaning Validation of API Plant and Equipment

Manual - 039 Sterilization Process Validation

Manual - 040 Cleaning and Cleaning Validation For Formulated Products
Manual - 041 Analytical Laboratory Procedure Validation
Manual - 042 Water Quality Standard
Manual - 043 Sterility Testing Procedure
Manual - 044 Endotoxin Testing Procedure
Manual - 045 Guideline for Stability Testing for R&D
Manual - 046 Storage and Expiry Dating of Analytical Reagents in Laboratory
Manual - 047 Preparation & Maintenance of Stability Protocols and Stability Master Plans
Manual - 048 Commercial Stability Testing of API (Pure Bulk Drug)
Manual - 049 Commercial Stability Studies at Contractors
Manual - 050 R&D Laboratory Quality Assurance Record Retention Procedure
Manual - 051 Microbiological Testing for Non Sterile Drug Product
Manual - 052 Reference & Retention Samples
Manual - 053 Laboratory Equipment Qualification
Manual - 054 Manufacture and Microbiological Testing of Sterile API & Drug Product Within
R&D
Manual - 055 Commercial Stability Testing For Formulated Products
Manual - 056 Environmental Monitoring
Manual - 057 Trending of Stability Data
Manual - 058 Laboratory Out of Specification Results Investigation
Manual - 059 Manufacturing Documentation
Manual - 060 Maintenance and Calibration of GMP Critical Items in Manufacturing
Operations and R&D
Manual - 061 Retreatment and Blending of API & Formulated Product
Manual - 062 In-Process Testing, Checks and Sampling
Manual - 063 Management of Returned Goods
Manual - 064 Receipt Handling and Storage of Starting & Packaging Materials
Manual - 065 Control of Packaging Operation
Manual - 066 Requirements of Facilities For Sterile and Non-sterile Drug Manufacturing
Manual - 067 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
Manual - 068 Principles and Responsibilities for The Management of Change in
Manufacturing Operations
Manual - 069 The Validation of Facilities and Systems
Manual - 070 Information Technology Infrastructure Qualification
Manual - 071 Management of Change in Computerised System
Manual - 072 Access by Regulatory Authorities and Auditors to Electronic Records
Manual - 074 Electronic Records and Electronic Signatures
Manual - 077 Analytical Procedures and Validation
Manual - 078 Technology Transfer of Established Medicine from One Commercial Site to
Other

GMP Guidance - Quality and Validation Guidance

Analytical Test 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 Product for Equipment Cleaning

Guidance 009
Equipment
Guidance 010
Guidance 011
Guidance 012
Guidance 013
Guidance 014

- Guidance for Swab Sampling and Visual Inspection Locations for API
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Product and Equipment Grouping and Worst Case Product Selection

Rinsate and Swab Sample,Test Method Development and Validation
Visual Inspection and Quantitation Practices
Cleaning Verification Investigating Unknown Peaks in Chromatography
Cleaning Evaluation Documentation and Records for Cleaning Activities

Process Validation, Packaging Validation and Equipment Qualification

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 DP 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 and 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 and 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 and Toxicity Data
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
Guidance 035 - Non-Sterile Active Pharmaceutical Ingredient (API) Manufacturing Area
Guidance 036 - Potential Critical Packaging 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 Commercial Use of Drug Product and API Pre-Validation and
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 During Validation
Guidance 046 - Validation Test Deviations
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
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 Documentation
Guidance 057 - Packaging Process Documentation Transfer for Drug Products
Guidance 058 - Purified Water and Water for Injection System Commissioning and
Qualification Sampling Plans
Guidance 059 - Quality Considerations for Direct Impact Compressed Air and Nitrogen
Systems

Quality Assurance Management

Guidance 060 - Product Quality Complaint Handling
Guidance 061 - Application of Quality Risk Management (QRM) to Periodic Review of SOPs
Guidance 062 - Statistical Rationale for Raw Material Sampling
Guidance 063 - Quality Risk Management for Critical Instrument Calibration
Guidance 064 - Structured On-the-Job Training System
Guidance 065 - Training system for Aseptic and Preparation forAseptic Operators and
Support Staf
Guidance 066 - Disposal of Rejected and Waste Materials
Guidance 067 - QA Self-Appraisals
Guidance 068 - Material Status Indication
Guidance 069 - Annual Product Records Review Guideline
Guidance 070 - Receipt, Approval and Use of Labels and Labeling
Guidance 071 - Weighing and Measuring Practices In Manufacturing Operations
Guidance 072 - Material Supplier Approval
Guidance 073 - Storage & Distribution of Drug Products and Medical Devices
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 081 - GMP Training System
Guidance 082 - Stability Testing
Guidance 083 - Quality Risk Management (QRM) Application to Identify Deviations vs.
Events
Guidance 084 - 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 - Risk Management Application 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
Guidance 094 - Systems Validation
Guidance 095 - Metal Detection
Guidance 096 - Hose Management

Guidance 097 - Use of Process Analytical Technology

Guidance 098 - Implementation of Process Analytical Technology
Guidance 099 - Validation of Process Analytical Technology System

Aseptic Processing
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 & Retesting During Micro OOS Investigation
Guidance 107 - Gamma Radiation Sterilization
Guidance 108 - Lyophilization
Guidance 109 - Lyophilizer Loading and Unloading Recommendations
Guidance 110 - Microbial Attributes Testing of Non-Sterile Solid
Guidance 111 - Microbiological Testing in Cleaning Validation for APIs and Drug Products
Guidance 112 - Overview of Trending of Environmental Monitoring
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
Guidance 117 - Sterilization or Depyrogenation Validation - Non Product
Guidance 118 - Unplanned Cleanroom Power Outage Time Limit and Recovery
Guidance 119 - Use of Sterilized Goggles Within the Aseptic Processing Area
Guidance 120 - Water Activity in Pharmaceutical Manufacturing
Guidance 121 - Assessment of Shipping Processes for Drug Products
Guidance 122 - Cold Chain Management of Biopharmaceutical Materials
Guidance 123 - Stability Considerations for Planned or Unplanned API Process Changes
Guidance 124 - Clean Process - External Vial Capping Operations
Guidance 125 - Use and Recovery of Solvents in API Manufacturing

Good Working Practice

Practice 01: Good Working Practice on 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

Practice 02: Good Working Practice on Material Management

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: Good Working Practice on Labelling 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

Practice 04: Good Working Practice on Manufacturing 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

Practice 5: Good Practice on Laboratory Management

Analytical Laboratory Investigations
Foreign Matter Control, Testing and Inspecting of Sterile Products
Evaluation and Investigation of Trace Unidentified Chromatographic Peaks
Laboratory Documentation
Laboratory Management
Stability Testing

Sterility and Bacterial Endotoxin Testing

Sterility Test Isolators
Transfer of Analytical Methods
Use and Control of Laboratory Reagents and Reference Standards
Verification of Compendial Analytical Methodology