Equipment and system qualification is a systematic and documented procedure aimed at demonstrating that a pharmaceutical manufacturing facility equipment, utilities and facilities are properly installed and function as designed and in a manner that meets validated parameters. Qualification is part of the DQ → IQ → OQ → PQ process sequence and is a very essential GMP requirement in EU GMP Annex 15, ICH Q7, FDA guidance and PIC/S PI 006 as well as WHO GMP guidelines. All manufacturing equipment, including a tablet compression, an autoclave or a water system has to be qualified before it can be used in production. Pharmaceutical Qualification Protocol & Report formats are provided for Equipment, Utilities, HVAC, Water system & Laboratory Instruments.
📋 Qualification Protocols and Formats
- AHU Performance Qualification (PQ) Protocol: Environmental Monitoring & Validation Guide
- AHU Operational Qualification (OQ) Protocol: Testing Procedures, Formats & Limits
- AHU Installation Qualification (IQ) Protocol: Complete Guide with Format & Checklist
- Performance Qualification of Purified Water System
- Design Qualification Purified Water Storage & Distribution System/ PDF
- Design Qualification of Purified Water Generation System as per USP Standards
- Design Qualification Of FBD in Pharmaceuticals
- Installation Qualification Protocol for Automatic four head Vial Sealing Machine
- Operational Qualification of Automatic High-Speed Linear Vial Washing Machine (Protocol)
- IQ of High Speed Linear Vial Washing Machine
- Operational Qualification of Automatic Injectable Powder Filling With Rubber Stopping Machine
- Installation Qualification of Automatic Injectable Powder Filling With Rubber Stoppering Machine
- Operation Qualification of Sterilizing and Depyrogenation Tunnel
- Installation Qualification of Sterilizing and Depyrogenation Tunnel (Protocol)
- Operation Qualification of Steam Sterilizer cum Bung Sterilizer (Protocol)
- Installation Qualification of Steam Sterilizer cum Bung Processor (Protocol)
- Performance Qualification of Automatic Capsule Filling Machine
- Operational Qualification of Automatic Capsule Filling Machine
- Installation Qualification Protocol for Automatic Capsule Filling Machine
- Performance Qualification Protocol for Blister Machine
- Blister Machine Operation Qualification Protocol/ Annexures
- Installation Qualification Protocol for Blister Packing Machine with Annexures
- Qualification and Types of Qualification (DQ, IQ, OQ, and PQ)
- Blender Installation Qualification Protocol/ Annexures
- Operational Qualification Protocol of Pillar Type Blender
- Blender Performance Qualification Protocol/ Annexures
- Auto Coater Operational Qualification Protocol/ Annexures
- Auto Coater Performance Qualification Protocol
- Auto Coater Installation Qualification Protocol/ Annexures
- Design Qualification of Electric Stacker
- Design Qualification Protocol for Vertical Laminar Reverse Flow
- Design Qualification in Pharmaceutical industry
In this Section you will learn about:
Qualification templates in this section cover all areas and type of equipment used in the GMP pharmaceutical manufacturing. All formats are designed to address today’s regulatory requirements and encompass the entire protocol-to-report process.
- User Requirement Specification (URS) templates are provided.
- Design Qualification (DQ) formats are to be used on the following:
- Installation Qualification (IQ) protocols and reports.
- Operational Qualification (OQ) protocols and reports have been developed.
- Performance Qualification (PQ) protocols and reports
- Validation Master Plan (VMP) templates are provided.
- Manufacturing equipment qualification — tablet presses, granulators, blenders, coating pans and filling machines
- HVAC & cleanroom qualification
- Water system qualification (PW, WFI)
- Qualification of autoclave and steriliser
- Qualification of lyophiliser (freeze dryer)
- Qualification of laboratory instruments, such as HPLC, dissolution, UV, balance.
- Computerised system validation (CSV) according to per GAMP 5 & 21 CFR Part 11
- Requalification / periodic review templates.