Pharmaceutical Validation Services
High-quality reports, experienced staff, and efficient processes
Pharmaceutical Validation Services
Pharmaceutical Validation Services
High-quality reports, experienced staff, and efficient processes
Pharmaceutical Validation Services
Overview
Our 21 CFR Part 11 compliance checklist assessment and remediation services help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures and that those functions are in conformance with the requirements of 21 CFR Part 11 compliance. Our extensively trained professionals evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 compliance checklist and assessment determines the effectiveness of a client's process within a highly regulated environment and suggests appropriate remedial actions as necessary.
We can give our clients an unmatched, in-depth, and thorough inspection of their systems and procedures. We ensure compliance with the requirements of 21 CFR Part 11 through our years of experience and solutions that are unique to you and your company's needs.
Stellar Automation
Services
Our pharma validation services 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 Summary Reports.
- Performance Qualification (PQ) Protocols.
- Cleaning / Sanitation Validation Protocols.
Qualification & Validation Areas of Pharma companies:
The qualification phase pertains to actions given how specific equipment gives the expected results & works properly.
Qualification stages:
- Design qualification
- Installation qualification
- Operation qualification
- Performance qualification
Validation stages:
The 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 equipment
- 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
- Labeling
- Cross-contamination
- Process validation
Sampling zones / Warehouses
- Clean rooms
- HVAC
- Direct airflow 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
