All Pharma validation services companies provide a comprehensive validation service at every stage of the project life cycle. These companies assist with all aspects of validation relating to equipment, facilities, GMP utilities and computer systems. Pharma validation services ensures support to clients in developing, implementing and achieving a validation strategy and programme that is designed to meet the customers’ timescales and budget whilst fully satisfying the cGMP requirements and the regulatory obligations of the licensing bodies.
It begins from the design stages of a project i.e. during User Requirement Specification (URS) development, Design Reviews right through Vendor Factory Acceptance Testing (FAT) to site Commissioning, Installation Verification and Qualification (IQ), Operational Testing and Qualification (OQ) and Performance Qualification (PQ).
Pharma validation services typically include:
- Validation Master Plans / Validation Plans.
- Design Qualification.
- Design Reviews Support.
- Computer Systems Report.
- Installation Qualification (IQ) Protocols.
- Site Validation Execution.
- Operation Qualification (OQ) Protocols.
- Final Validation Summery Reports.
- Performance Qualification (PQ) Protocols.
- Cleaning / Sanitation Validation Protocols.
All projects should be delivered by the engineering company with a precise level of Project Management, Scheduling and Cost Control Metrics to monitor progression.
The engineering company providing Pharma validation services has to carefully plan the entire process cycle of the project. The guiding document on qualification & validation of the object has to be the Validation master plan. Along with the technical expertise, the pharma validation services company cannot ignore the importance of including several specialists i.e. technologists, engineers, metrologists etc.
Qualification & Validation Areas of Pharma companies:
The qualification phase pertains to actions given how a specific equipment gives the expected results & works properly.
Qualification stages:
- Design qualification
- Installation qualification
- Operation qualification
- Performance qualification
Validation stages:
Validation phase relates to actions that in accordance with the principles of good manufacturing practice prove that a specific method, approach, process, equipment etc gives the expected results.
Validation services:
- Validation of sterilization process
- Media fills
- Process validation
- Cleaning validation
- Validation of the cold chain
- Validation of the monitoring, the automated control systems
List of activities:
Typical pharma validation services companies prepare the following reports:
Production premises:
- Clean rooms
- Isolators & other barrier systems
- HVAC systems
Sterilization:
- Steam sterilization
- Dry heat sterilization
- Ethylene oxide sterilization
- Formaldehyde sterilization
- Depyrogenation
- SIP systems
Washing & Cleaning processes:
- CIP systems
- Primary packaging & Auxiliary materials washing
- Cleaning validation
Pure media
- Water for injection
- Highly purified water
- Clean steam
- Compressed air, nitrogen & other gases
Other production processes / Production of equipments:
- Preparation of solutions, ointment bases
- Dry powder filling
- Lyophilization
- Decontamination of external surfaces
- Optical control
- Granulation
- Homogenization
- Tableting, coating, capsule filling
- Blister packaging
- Cartoner, group packaging
- Labelling
- Cross contamination
- Process validation
Sampling zones / Warehouses:
- Clean rooms
- HVAC
- Direct air flow zones
- Special storage conditions chamber
- Validation of cold chain processes
Monitored, automated control systems:
- Production premises
- Pure media
- Production equipment
- Production processes
- Production storage & warehousing
Laboratories, hospitals, clinics, pharmacies etc.
- Clean rooms
- HVAC systems
- Laminar boxes, isolators, biological safety cabinets
- Thermostats, incubators, refrigerators, freezers
- Stabilization boxes
- Sterilization & depryogenation processes
- Washing, cleaning & Decontamination processes
It’s a simple question, not always the easiest to answer. Which could be the best pharma validation services company? How to evaluate? Panorama’s pharmaceutical compliance and validation services combined with pharmaceutical consultancy services are all aimed at making this an easier question to answer.
