ATC Corporation
When Direction Matters
When Direction Matters
Validation Systems
Validation Planning
Companies that manufacture medicines, drug related products, parenteral/oral/ topical/ophthalmic solutions, blood related products, biotechnology products, clinical supplies and medical devices for human or animal use are required by law to meet specific regulatory standards for the development, manufacture and distribution of these products.
One aspect of regulation is the inspection of the manufacturing facility by governmental regulatory authorities for compliance with specific standards including, cGMP’s and cGLP’s as dictated by such agencies as the Food & Drug Administration [FDA] in the U.S., Health Protection Board [HPB] in Canada and EU Directives in Europe.
ATC offers guidance and "hands on" support for pharmaceutical, medical device and OTC companies in the following critical compliance areas:
Validation Approach
ATC’s approach is intended to achieve integrity throughout the life of a facility in addition to ensuring rapid regulatory compliance for specific submissions, applications or in response to inspections. Our objectives are implemented by the application of the ‘Life Cycle concept. This concept integrates the efforts of the validation team with engineering design, construction, production and quality teams.
The Life Cycle concept achieves project completion with optimum schedule and cost. For existing facilities, concurrent and retrospective validation programs can be developed for the requirements of imminent or existing systems to meet compliance standards.
ATC’s program is designed to provide the client with a facility which can easily be maintained in a validated state. This is achieved by providing mechanisms for ongoing change control and evaluation of validation requirements. This allows for effective determination of the impact on the validated facility and the need for revalidation.
A typical validation project, which may be provided turnkey by ATC Corporation or in coordination with the client’s overall validation program, includes the following activities:
Areas Of Expertise
ATC delivers the following services:
cGMP Services
ATC delivers validation support programs in the following areas:
Relevant Project Experience
ATC Key Services
Web Based Productivity Solutions
ATC Corporation delivers:
Companies that manufacture medicines, drug related products, parenteral/oral/ topical/ophthalmic solutions, blood related products, biotechnology products, clinical supplies and medical devices for human or animal use are required by law to meet specific regulatory standards for the development, manufacture and distribution of these products.
One aspect of regulation is the inspection of the manufacturing facility by governmental regulatory authorities for compliance with specific standards including, cGMP’s and cGLP’s as dictated by such agencies as the Food & Drug Administration [FDA] in the U.S., Health Protection Board [HPB] in Canada and EU Directives in Europe.
ATC offers guidance and "hands on" support for pharmaceutical, medical device and OTC companies in the following critical compliance areas:
- Quality Systems and compliance development
- FDA 483 and Warning Letter responses and action plans
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Development and review of individual compliance documents and record-keeping systems, including:
- Master Batch Records [MBRs]
- Device Master Records [DMRs]
- Device History Records [DHRs]
- Device History Files [DHFs]
- Standard Operating Procedures [SOPs]
- Standard Test Procedures [STPs]
- Development and implementation of complaint handling systems
- Development and implementation of Corrective and Preventive Action [CAPA] systems
- Design control process development, implementation
- Process automation and control
- Process analysis/methods improvement
- Method and process validation
- Software and computer systems validation
- IQ/OQ/PQ of equipment and systems
- Development and implementation of Validation Master Plans
- QS Regulation, GMP, GLP and GCP
- Development of training programs for personnel at all levels
- Internal Audit and clinical audit training
Validation Approach
ATC’s approach is intended to achieve integrity throughout the life of a facility in addition to ensuring rapid regulatory compliance for specific submissions, applications or in response to inspections. Our objectives are implemented by the application of the ‘Life Cycle concept. This concept integrates the efforts of the validation team with engineering design, construction, production and quality teams. The Life Cycle concept achieves project completion with optimum schedule and cost. For existing facilities, concurrent and retrospective validation programs can be developed for the requirements of imminent or existing systems to meet compliance standards.
ATC’s program is designed to provide the client with a facility which can easily be maintained in a validated state. This is achieved by providing mechanisms for ongoing change control and evaluation of validation requirements. This allows for effective determination of the impact on the validated facility and the need for revalidation.
A typical validation project, which may be provided turnkey by ATC Corporation or in coordination with the client’s overall validation program, includes the following activities:
- Training and Consultation
- Preparation of Validation Master Plan
- Engineering & Construction Review
- Regulatory Authority Liaison/Meeting
- Development and Implementation of Calibration and Preventative Maintenance Programs
- SOP Development and Review Process
- Support Program Development
- Validation Protocol Preparation and Execution (IQ/OQ/PQ)
- Validation Summary Report Preparation
- Facility Inspection/PAI/FDA Review
Areas Of Expertise
Experienced ATC Corporation employees have performed validation and cGMP compliance services in conjunction with in-house BioPharmaceutical engineering services. ATC’s Validation Services Department was established in 1995 as more requests came in for these specialty services in response to evolving government regulations. ATC continues to accumulate experience via hands-on validation and compliance consulting projects for our clients.
ATC delivers the following services:
| Batch Organic Synthesis | HVAC, Water & Utility Systems | Biocontainment |
| Laboratory Services | Calibration/Metrology | Product Finishing |
| CFR Interpretation | Bulk Chemical Production | cGMP/cGLP Compliance |
| Computer Systems/PLC | Product Formulation | International Regulations |
| Biological Production | Medical Devices | Medical Gases |
| Sterile Dosage/Parenterals | Isolation Technology | Validation/Support Program |
| Solid Dosage Forms | OTC Compliance |
cGMP Services
ATC’s Validation Services Department has provided contract services to pharmaceutical, biotechnology, medical device, diagnostic and bulk manufacturers. ATC Corporation has successfully completed projects world-wide, including projects for companies located in South American, Puerto Rico, Korea, Canada and the United States.
ATC Corporation provides validation personnel to support projects ranging from full facility validation to individual equipment qualifications. The Validation and cGMP Compliance Services organization is structured to meet the exacting requirements of each of our clients. ATC approaches each project with the perspective of adding value to the project while recognizing budget and schedule requirements.
ATC Corporation provides validation personnel to support projects ranging from full facility validation to individual equipment qualifications. The Validation and cGMP Compliance Services organization is structured to meet the exacting requirements of each of our clients. ATC approaches each project with the perspective of adding value to the project while recognizing budget and schedule requirements.
ATC delivers validation support programs in the following areas:
- Equipment Qualification
- Utility Qualification
- Process Validation
- Cleaning Validation
- Computer Validation
- Methods Validation
Relevant Project Experience
ATC Corporation has worked with engineering companies, support service organizations and other contract validation groups. Our organization advocates a team approach in order to achieve successful project execution. ATC consistently strives to establish a team rapport with all organizations to assure successful completion of the project and goals. This approach allows us to work successfully on projects with companies, such as FMC, Glaxo-SmithKline and Astra-Zeneca.
ATC has provided validation and regulatory consulting services to clients worldwide. We have successfully written and executed validation protocols from the most commonly seen manufacturing and laboratory equipment (such as autoclaves and incubators), to the most unique manufacturing and process applications. In all cases, ATC has worked with both the client and regulatory authorities to develop effective and acceptable qualification programs.
ATC has provided validation and regulatory consulting services to clients worldwide. We have successfully written and executed validation protocols from the most commonly seen manufacturing and laboratory equipment (such as autoclaves and incubators), to the most unique manufacturing and process applications. In all cases, ATC has worked with both the client and regulatory authorities to develop effective and acceptable qualification programs.
ATC Key Services
ATC Validation continues on the cutting edge of technology by providing hands-on validation of the latest, most sophisticated equipment and systems including the following areas:
- High Level Computer Systems Management
- Fully Automated Visual Inspection Machines
- Aseptic Filling Lines
- Isolation Technology
- Blow-Fill Seal Technology
- Microwave Sterilization
- Transdermal Technology
- Solid Dosage Technology
- Microbial Containment
- Chemical Decontamination
Web Based Productivity Solutions
ATC offers AUTOTASK a proprietary Web based project management tool that improves productivity, communications and profitability. AUTOTASK will help monitor and schedule projects, assign resources and build project teams from roles, billing rates and allocation codes. This unique web-based product includes Gantt charts, real-time status reports, and controlled client access to streamline the process from start to end.
ATC Corporation delivers:
- Easy viewing of what's due, done and overdue
- Monitoring of anticipated cost overruns against budget
- Creation of improved time estimates and proposals
- Instant Status reports, eliminated whiteboards and spreadsheets
- Better accountability and response time
- Increased billable hours and resource utilization
- Cross Project reporting; do in seconds what took hours to do by hand.
- Elimination of costly manual paperwork and processing
- Access real-time information for review or planning
- The ability to analyze performance to identify problems
- Extensive reporting to keep projects on track
- Controlled accessibility to various levels with secure, user-specific log-ins
- Improved communications with project teams and customers
- Viewable real-time reports on time and expenses for one or all projects
- A system which allow for the management of billable hours efficiently
