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The
manufacturing world turns more competitive everyday, thus, requiring
resources to response in a suitable manner. Quality Consulting
Services has the top qualified personnel for these needs. We draw strength
from the technical expertise of our personnel. These exchanges of technical
knowledge and expertise will assist your organization in reaching your
goals.
The staff at Quality Consulting Services has a vast experience in validation
and in providing a complete, reliable and regulatory compliant documentation
package as the evidence to support the validation exercises. Combining
the expertise and knowledge of our team, we can truly help make a difference
in your organization. At Quality Consulting Services, we strive for
excellence.
Our Regulatory &
Compliance division will assist you in key areas such as: Audit programs,
Pre-audit activities in preparation to corporate, clients or agencies
visits, design and implementation of Change Control System, Suppliers
Certification Program, Corrective Action/Preventive Action process,
Reduce Testing Improvements, Investigations, Audit reports addressing
and observations resolution and many other services.
The Documentation Team
is ready and available to support you in documents and data review,
write up of procedures/working instructions/forms, design and implementation
of electronic documents tracking system, trainings, refresh seminars
and more.
Quality Consulting Services can provide validation services in the following areas:
Cleaning Validation:
Lead, development and execution of validation documentation related to the following cleaning processes:
- Manual Wash
- Clean in Place (CIP) Process for Formulation Equipment
- Ultrasonic sinks washers
- Development of Standard Operating Procedures (SOP)
- Tanks CIP Cycle Optimization
Lead, development, execution and/ or revision of validation documentation related to:
Equipment:
- Freeze Dryers
- Depyrogenation Ovens
- Depyrogenation Tunnels
- Autoclaves
- Cold Rooms/Freezers
- ICOS Stopper Processing Machine
- Incubation Rooms
- Stopper Placement Units
- Syringe Filling Equipment
- Vial Filling Equipment
- Formulation Tanks: (Buffers, Mixing and Storage Tanks)
- Label Counters
- Clean in Place Portable Units
- Ultrasonic Sink Washers
- Tray Loaders
- Vial Washer
- Vial Capper
Utilities Validation:
- Water for Injection
- Purified Water
- Clean Steam
- Compressed Clean Air
Process Validation:
- Product Transfer/New Products
- Introduction
- Formulation Process
- Filling Process
- Filter Validation
- Batch Size Increase
- Water and Media Fills
Facilities:
- Vial Formulation and Filling Area
- Heating, Ventilating and Air
- Conditioning (HVAC) Systems
- Clean Rooms Qualification
Other:
- Process Capability Studies
- Audit
- Master Plans
- Programming Logic Controllers (PLC)
- Development of equipment requirements for manufacturing equipment
- 21 CFR Part 11 Compliance
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