Standard Operating Procedures, Manuals

Part 1: Standard Operating Procedures

1.1: 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
Standard Operating Procedures, Manuals

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
QMS-140 Root Cause Analysis Investigation Procedure
QMS-145 Classification of Defects in Manufacturing
Operation
QMS-150 Classification of defects for incoming packaging
components
QMS-155 External Audit Procedure
QMS-160 Personal Hygiene Jewellery and Clothing Policy
QMS-165 Good Documentation Practice
QMS-170 Product Quality Reviews for Contract
Manufactured Products
1.1.1: Quality Assurance Templates
Standard Operating Procedures, Manuals

TEMPLATE-005 Raw Material Specification and Test Report

Template
TEMPLATE-080 Internal Audit Report Template
TEMPLATE-085 Training Report Template
TEMPLATE-090 Form Template
TEMPLATE-095 SOP Template
TEMPLATE-100 Quality Assurance Agreement Template
TEMPLATE-105 Third Party Manufacture Dispatch Report
Template
TEMPLATE-110 In-House Manual Template
TEMPLATE-115 Protocol Rework- Manufactured Finished
Goods
TEMPLATE-120 Vendor Audit Report Template
TEMPLATE-125 Protocol Rework- In Process Manufactured
Goods
TEMPLATE-130 Position Paper Template
TEMPLATE-135 Control Method Template
TEMPLATE-140 Formulation Template
TEMPLATE-145 Finished Product Specification and Test
Report Template
TEMPLATE-150 Packaging Material Specification and Test
Report
TEMPLATE-155 Bill of Materials Template
1.2: Pharmaceutical Audit Training Manuals
Standard Operating Procedures, Manuals

Audit – 01 Auditing Principles for GMP Audit

Audit – 02 Understanding Worldwide Regulatory
Requirements
Audit – 03 Auditing a Personnel & Training System
Audit – 04 Auditing a Deviation Management System
Audit – 05 Auditing a Validation System
Audit – 06 Auditing a Change Management System
Audit – 07 Auditing a Complaint System
Audit – 08 Auditing a Documentation System
Audit – 09 Auditing a Calibration, Preventative Maintenance
& Housekeeping System
Audit – 10 Auditing Computerised Systems
Audit – 11 Auditing Utilities System
Audit – 12 Auditing Warehouse and Distribution System
Audit – 13 Auditing Environmental Monitoring System
Audit – 14 Auditing Microbiology and Sterility Testing
Laboratory
Audit – 15 Auditing an Analytical Quality & Stability Testing
Laboratory
Audit – 16 Auditing a Material Handling System
Audit – 17 Auditing an Active API Manufacturer
Audit – 18 Auditing Packaging Material Vendors
Audit – 19 Auditing a Packaging and Labeling Operation
Audit – 20 Auditing an Aseptic Sterile Area
Standard Operating Procedures, Manuals

Audit – 21 Auditing an Excipient Supplier

Audit – 22 Auditing an Oral Solid Solution Area
1.3: 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
Standard Operating Procedures, Manuals

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 Development of a User and Functional Requirement
Specification
VAL-145 Development of A Functional Requirement
Specification for Computer Systems
VAL-150 Conducting an Electronic Record and Signature
Assessment
VAL-155 Handling of Material Used for Trials
VAL-160 Periodic Review of Systems and Processes
VAL-165 Packaging Trials
VAL-170 Guideline for the Validation of Excel Spreadsheets
Standard Operating Procedures, Manuals

VAL-175 Validation of Autoclaves, Autoclave Loads and

Cycles
VAL-185 Guidance for the use of Risk Assessment in
Validation
VAL-190 Guideline for the Validation of Aseptic Processing
VAL-195 Maximum Safe Carry-Over (MSCO) Determination
VAL-200 Selection and Use of Biological Indicators during
Validation Studies
VAL-205 Management of Validation Protocols and Reports
VAL-210 Computer Validation Master Plan
VAL-215 Cleaning Validation Master Plan – Non-Sterile Solid
VAL-220 Cleaning Validation Master Plan – Veterinary
Biologicals
VAL-225 Procedure for Performing Steam in Place (SIP)
Validation
VAL-230 Procedure for Cleaning Validation Coverage Testing
1.3.1: Validation Templates
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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
1.4: Quality Control Analytical Laboratory Procedures
LAB-005 Retest Dating of Raw Materials
LAB-010 Calibration Policies for Laboratory Instruments
LAB-015 Archiving Laboratory Documentation
LAB-020 Management of Reference Substances
LAB-025 Laboratory Workbook
LAB-030 Creation of Certificate of Analysis
LAB-035 Managing Analytical Reagents
LAB-040 Laboratory Waste Management
LAB-045 Retention Samples Management in Laboratory
LAB-050 Laboratory Supplier Approval
LAB-055 Laboratory Results Out of Specification
Investigation
LAB-060 Laboratory Testing and Documentation of Raw
Materials
Standard Operating Procedures, Manuals

LAB-065 Laboratory Testing and Documentation of Finished

Products
LAB-070 Preparation and Maintenance of Stability Protocols
for pharmaceuticals Products
LAB-075 Stability and Trial Testing Procedure for
pharmaceuticals Products
LAB-080 Preparation of Disinfactant solution IPA
LAB-085 Laboratory Analytical Determinations
LAB-090 HPLC Reproducibility, Column Performance and
Testing Guidelines
LAB-095 HPLC Method Development & Validation
Procedure
LAB-100 Laboratory in Process and Finished Product Quality
Control
LAB-105 Laboratory Housekeeping and Glassware Cleaning
LAB-110 Safety Procedure in Laboratory
LAB-115 Use and Control of laboratory Chemical Materials
LAB-120 Qualification of Laboratory Instruments
LAB-125 Sampling of Raw Materials, In-process and Bulk
Finished Product
LAB-130 Stability Management Procedure
LAB-135 Validation of Analytical Test Procedure
1.5: Microbiology Laboratory & Sterility Testing Procedures
MICLAB-005 Entry Procedure for Sterile Filling Areas
Standard Operating Procedures, Manuals

MICLAB-010 Validation of Aseptic Gowning Procedures

MICLAB-015 Microbiological Data Recording Procedure
MICLAB-020 Destruction of Biological Waste in
Microbiology Laboratory
MICLAB-025 Dehydrogenation 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
Standard Operating Procedures, Manuals

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
1.6: Standard Operating Procedure for Packaging Operation
MAN-005 Clothing Requirements Inside the Factory Area
MAN-010 Cleaning Responsibilities and Methods for
Employees
MAN-015 Factory Cleaning Procedure
Standard Operating Procedures, Manuals

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-075 Example of a Tablet Packing Machine -
Construction, Operation and Cleaning
MAN-080 Example of Manufacturing Instruction for Tablet
Packing
MAN-085 Mop Cleaning Procedure
MAN-090 Scheduling of Production Lines
MAN-095 Vacuum Leak Testing Procedure for Finished
Goods
MAN-100 Weighing Equipment – Checking and Calibration
MAN-110 Example of Operation of automatic Checkweigher
for Finished Packs
Standard Operating Procedures, Manuals

MAN-115 Machine Start up Challenges and In-Process

Testing Procedures
MAN-120 Finished Pack Sampling by Production Personnel
MAN-125 Component Return Procedure From Packaging
Floor
1.7: 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
Standard Operating Procedures, Manuals

WAR-075 Example of Tablet Dispensary Procedure

WAR-080 Example of Tablet Sampling Procedure as Raw
Material
WAR-085 Sampling and Inspection of Raw and Bulk
Materials
WAR-090 Sampling Inspection and Release of Packaging
Materials
WAR-095 Status Labels
WAR-100 Sampling of Raw Materials in Sampling Booth
WAR-105 Cleaning of Sampling Booths and Implements in
the Raw Materials Quarantine Store
WAR-110 Classification of Defects for Iincoming Packaging
Components
WAR-115 Storage or Handling Rules for Inventory Items
1.8: Environmental Health and Safety Procedures
EHS-005 Hazardous Chemical Substance Management
EHS-010 Environmental, Health and Safety Risk
Management
EHS-015 Waste Removal Process
EHS-020 Identifying EHS Issues
EHS-025 EHS Incident Management Procedure
EHS-030 First Aid Procedure
EHS-035 Blood and Body Fluid Spill Management
EHS-040 Blood Borne Pathogen Exposure
Standard Operating Procedures, Manuals

EHS-045 Building Cleaning Procedure

EHS-050 Environmental Management System Plan
EHS-055 Environmental Aspect Register
EHS-060 Fire Protection Impairment Handling
EHS-065 Hot Work Permit Procedure
EHS-070 Hazard Identification and Incident Investigation
Reports
EHS-075 First Aid Procedure
EHS-080 Industrial Hygiene Sampling for Airborne
Contaminants
EHS-085 General Security Procedure for GMP Manufacturing
Area
EHS-090 Occupational Medical Support Procedure for a GMP
Site
EHS-095 Pharmaceuticals Pest Control Procedure
EHS-100 Personal Protective Equipment (PPE) Policy for a
GMP Manufacturing Site
EHS-105 Environmental Health and Safety Training
EHS-110 Laboratory Spill Response
EHS-115 Process Safety
EHS-120 Industrial Hygiene Sampling
EHS-125 Selection of Personal Protective Equipment (PPE)
EHS-130 Environmental Health and Safety Risk Assessment
Methodology
Standard Operating Procedures, Manuals

Part 2: Quality and Validation 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 – 003 Certificate of Materials Supplied to Receiving
Manufacturing Site
Manual – 004 Quality Assurance Agreements
Manual – 005 Procedure for Quality Assurance Management
of Contractors
Manual – 006 Guidelines for Regulatory Inspections
Manual – 007 Quality and Compliance Auditing
Manual – 008 Auditor Training
Manual – 009 Facility Based R&D QA Audit
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 – 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
Standard Operating Procedures, Manuals

Manual – 018 Computerized Systems Risk Management

Manual – 019 Batch Confirmation Certification & Release by
a Qualified Person within the EU
Manual – 020 Cross Contamination Risk Evaluation Process
for Commercial Compounds
Manual – 021 Certificate of Analysis & Certificate of
Manufacture
Manual – 022 Pharmaceutical Product Reviews
Manual – 023 Warehousing and Distribution of Commercial
Products
Manual – 024 Utility Standards
Manual – 025 Conducting Investigations
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 – 029 Manufacturing Deviation Management
Manual – 030 Study Based GLP Quality Assurance Audit for
Critical Phases
Manual – 031 Guideline for Development and Contents of
Specifications
Manual – 032 R&D QA Audits for Suppliers and Vendors
Manual – 033 Manufacture Packing and Shipping of Materials
Ahead of Full QA Clearance
Standard Operating Procedures, Manuals

Manual – 034 Determination of Storage Periods for APIs

Excipients Intermediates and Raw Materials
Manual – 035 The Preparation of Process Validation Master
Plan
Manual – 036 Process Validation of Bulk Drug (API and
Intermediate)
Manual – 037 Process Validation for Formulated Products
Manual – 038 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&Dhy7777777777777777777777777
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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
Part 3: Quality and Validation Guidance
3.1: Analytical Test Method Validation Guidance
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
Standard Operating Procedures, Manuals

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
3.2: Cleaning Validation Guidance
Guidance 008 – Calculations of Residue Limits for Drug
Product 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 Practices
Guidance 013 – Cleaning Verification – Investigating
Unknown Peaks in Chromatography
Guidance 014 – Cleaning Evaluation Documentation and
Records for Cleaning Activities
3.3: Process Validation, Packaging and Equipment
Qualification Guidance
Guidance 015 – Critical Process Parameters for Drug Product
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
3.4: Quality Management Guidance
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
for Aseptic Operators and Support Staff
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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
3.5: Aseptic Operations 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
Standard Operating Procedures, Manuals

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
Standard Operating Procedures, Manuals

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
Guidance 126 – Establishing Reevaluation 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 – Labeling of APIs and API Intermediates
Guidance 130 – Post Approval Equipment Changes to API
Manufacturing Processes
Part 4: GMP Good Practices
Good Practice 01: Good Working Practice on Facilities and
Equipment
Standard Operating Procedures, Manuals

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 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
Standard Operating Procedures, Manuals

Storage and Distribution of Drug Products, Medical Devices,

and Related Materials
Subdividing Dispensing & Transferring Materials to
Production Areas
Quarantine Shipment
Good 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
Good 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
Standard Operating Procedures, Manuals

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.
Good 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
Standard Operating Procedures, Manuals

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
Microbiology Laboratory Investigations
Good Practice 6: Good Practice on Validation Requirements
Biological Test Methods Validation; Analytical Methods
Validation
Equipment Cleaning Validation for Active Pharmaceutical
Ingredients (APIs)
Equipment Cleaning Validation for Drug Products
Laboratory Equipment Qualification
Microbiological Methods Validation
Packaging Validation
Process Validation for Active Pharmaceutical Ingredients
(API)
Process Validation for Drug Products and Medical Devices
System Validation
Validating Aseptic Processing – Active Pharmaceutical
Ingredients (API)
Standard Operating Procedures, Manuals

Validation of Analytical Methods for Equipment Cleaning

Validation Requirements and Documentation
Part 5: List of All Quality Forms
Part 6: GMP Skill Booster Modules and Quiz
GMP Skill Booster: Quality Management Fundamentals
GMP Skill Booster: Cleaning Practices in GMP
GMP Skill Booster: Good Documentation Practice
GMP Skill Booster: Role of Warehouse in GMP
GMP Skill Booster: Good Laboratory Practice
GMP Skill Booster: Overview of Microbiology Tests
GMP Skill Booster: Overview of Packaging Operations
GMP Skill Booster: Preventing Contamination in GMP