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 & Finished Goods
QMS-120 Quality Concern Investigation Process
QMS-125 Change Management System
QMS-130 Cross Functional Investigation
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GMP Audit Training 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
GMP 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
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
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
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 Method
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 OOS Results
MICLAB-115 Operation and Calibration of Sievers 820 TOC Analyser
MICLAB 120 IPA Contamination Testing Procedure
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-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 forFinished Goods
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-120 Finished Pack Sampling by Production Personnel
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 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
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