Pharmaceutical Guidance Complete Pharma Solution
Validation
- User requirement specification (URS) of Tablets Automatic Coating Machine
- HVAC systems for non-sterile pharmaceutical as per WHO TRS. 937, 2006 ,Annex 2
- Temperature mapping of storage areas – TRS 961, Annex 9
- VIAL WASHING MACHINE PQ PROTOCOL
- Design Qualification of Gelatin Colour Mixer
- Installation Qualification of Gelatin Storage Vessel
- Principles of HVAC Duct Design in Pharma Industry
- Process Validation: General Principles (USFDA) in Pharma Industry
- Establishment of a Control Procedure in Pharma for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals
- Qualification of existing facilities, systems, equipment and utilities
- All Post URL of Drugs formulations
- Qualification & Validation of Equipment, Systems, Utilities in Pharmaceuticals
- PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM
- Guidance Document Cleaning Validation
- Non-sterile process validation
- Performace Qualification Protocol of Dispensing Booth
- Pharma Factory Acceptance Test for Automatic Strip Packing Machine
- SOP for Performance Qualification for Automatic Strip Packing Machine
- SOP for Performance Qualification for Auto Coater 48’’ GMP Model
- SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN
- SOP For Factory Acceptance Test for Tablet Compression Machine
- OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT
- INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT
- DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM
- Validation Observations Recording Format -I for steam steriliser and load Pattern
- Performance Qualification Report for steam steriliser
- Load Pattern & Justification for steam sterilizer
- Protocol for steam sterilizer and load Pattern
- Installation qualification for purified water generation system
- Alu Alu Blister Pack Machine
- Process Validation Guidance: FDA and Global
- New EU Requirements for Qualification & Validation
- Concept of URS,DQ,IQ,OQ,PQ in Pharma
- Documentation in cleaning validation
- Validation of Cleaning Processes
- Levels of Cleaning in cleaning Validation
- Validation of Sterilization Process in Autoclave
- Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)
- DISINFECTANT VALIDATION
- PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM
- Prospective Process Validation
- USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL
- Installation Qualification for Pass Box
- Operational Qualification for Pass Box
- DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)
- PERFORMANCE QUALIFICATION PROTOCOL
- Design Qualification of Pre-treatment & Purified Water Generation System
- Factory Acceptance Test of Automatic Capsule Filling Machine
- PILOT SCALE-UP AND PROCESS VALIDATION
- WHAT IS PROCESS VALIDATION?