What's in the Virtual Quality Manager
GMP|Manufacturing|Quality Assurance (QA) Management|Compliance Management|Quality Control (QC) Laboratory|Process Validation|ISO 9000 Quality Management Systems|Procedures and Manuals for Pharmaceuticals
Step by step pre-written operating procedures and manuals in the area of GMP (Good Manufacturing Practice), Manufacturing, Quality Assurance Management, Quality Control Laboratory, Process Validation for small and medium size pharmaceutical manufacturing and R&D businesses
All manuals and procedures are written by area experts to comply with the regulatory agencies like FDA, EU, MHRA, ISO 9000 series international standards, cGMP, HACCP, Workplace safety etc
Our goal is to provide a complete GMP & GLP model with a set of ready procedures and manuals which are easy to understand and readily applicable. All procedures are written with practical instruction examples and linked with other relevent procedures to have the clear understanding. Pocedures are grouped into seperate categories and prepared to guide you through how to establish a GMP Manufacturing Environment, Quality Assurance Management, Quality Control Laboratory Management, Process Validation System, Warehouse Management, Environmental Health and Safety Systems in your pharmaceutical manufacturing site
Content of our procedures are not only guidelines but a complete set of operating Instructions, Forms and Templates that will help you to build up your systems from today
Following is a list of Sample manuals and procedures from all categories for you to free download. For full version of manuals and procedures, browse the relevant sections on the category column. All procedures are written with practical examples devised with forms, visual aids and templates based on the guidelines of relevant manuals
GMP Manufacturing & Quality Assurance Manuals
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
Quality Auditor Training
Facility Based R&D Quality Assurance 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 EU
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 Materials
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
Sterilization Process Validation
Cleaning and Cleaning Validation For Formulated Products
Analytical Laboratory Procedure Validation
Water Quality Standard
Sterility Testing Procedure
Endotoxin Testing Procedure
Guideline for Stability Testing for R&D
Storage and Expiry Dating of Analytical Reagents in Laboratory
Preparation & Maintenance of Stability Protocols and Stability Master Plans
Commercial Stability Testing of API (Pure Bulk Drug)
Commercial Stability Studies at Contractors
R&D Laboratory Quality Assurance Record Retention Procedure
Microbiological Testing for Non Sterile Drug Product
Reference & Retention Samples
Laboratory Equipment Qualification
Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
Commercial Stability Testing For Formulated Products
Environmental Monitoring
Trending of Stability Data
Laboratory Out of Specification Results Investigation
Lean Manufacturing Documentation
Maintenance and Calibration of GMP Critical Items in Manufacturing Operations and R&D
Retreatment and Blending of API & Formulated Product
In-Process Testing, Checks and Sampling
Management of Returned Goods
Receipt Handling and Storage of Starting & Packaging Materials
Control of Packaging Operation
Requirements of Facilities For Sterile and Non-sterile Drug Manufacturing
Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
Principles and Responsibilities for The Management of Change in Manufacturing Operations
GMP Quality Assurance and Compliance Procedures
How to Write Standard Operating Procedure
All Documents - Classification, Definition and Approval Matrix
GMP Quality Documentation Management and Change Control
Documentation Rule for GMP Documents
GMP Quality Documentation - Control, Tracking and Distribution
Preparation, Maintenance and Change Control of Master Documents
Pharmaceutical Deviation Report System
Shelf Life of Product
Vendor Selection and Evaluation Procedure
Vendor Certification Procedure
Pharmaceutical Product Complaint Procedure
Annual Product Review
Manufacturing Rework Procedure
Responsibility of Authorized Person
Procedure for Product Identification and Traceability
GMP Audit Procedures
Example of Checklist for Batch Documentation
Evaluation of Batch Documentation and Release for Sale
GMP Training
How to Write GMP Training Materials
House Keeping Audit Procedure
Management and Control of Contract Work
Criteria for Sourcing of Raw Materials, Critical Packaging Components and Imported Finished Goods
Quality Concern Investigation Process
GMP Manufacturing Procedures for Tablet Packing
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 of a Tablet Packing Machine -Construction, Operation and Cleaning
Example of Manufacturing Instruction for Tablet Packing
Scheduling of Production Lines
Vacuum Leak Testing Procedure forFinished Goods
Example of Operation of automatic Checkweigher for Finished Packs
Machine Start up Challenges and In-Process Testing Procedures
Finished Pack Sampling by Production Personnel
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Quality Control Laboratory Procedures
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 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
Process Validation Procedures
Validation -Concept and Procedure
Revalidation Procedure
Method Validation Procedure
Procedure for Cleaning Validation
Validation of Laboratory Instruments
Equipment Specification and Qualification
In-House Trial Procedure
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 of Validation Plan
Example of Validation Report
Example of User Requirement Specification
Warehouse Management Procedures
Generation of Purchase Order For Inventory and Consumables
Procedure for Receipt of Incoming Goods
Incoming Raw Materials and Components-Handling by QC Sampler
Warehouse Processing Issues, Returns and Rejects
Dispatch of Goods From Warehouse
Warehouse Inventory Management Procedure
Design of Warehouse Locations and Storage Area
Finished Goods Transfer to Quarantine and Distribution Warehouse
Sampling Procedure of Raw Materials
Sampling of Components and Printed Materials
Safety Procedure of Warehouse Racking
Forklift Operation in Warehouse
Example of Tablet Dispensary Procedure
Example of Tablet Sampling Procedure as Raw Material
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Environmental Health and Safety Procedures
Hazardous Chemical Substance Management
Environmental, Health and Safety Risk Management
Waste Removal Process
Identifying EHS Issues
EHS Incident Management Procedure
First Aid Procedure
New Book From Us
"How To Get a Packing Operator Job in Pharmaceutical Industry"
USD 8
76 pages long, downloadable pdf file. Very popular unique guide for those who want to start their career in Pharmaceutical industry. Nicely explained with pictures althrough the book. To read the sample pages click on the link below
Read Sample Pages from the Book
To purchase this book browse the catagory "Machine Operator Job Book"
Thank you for your interest in ‘Your Virtual Quality Manager’ and Good luck to your business
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