Deliverables
- Author protocols and final reports for validation processes
- Validation Master Plan
- Functional requirement specifications
- Design specifications
- Identification of Critical Operating Parameters and defining Acceptance Criteria
- Testing execution
- Technical transfer assistance
- Employee training
- Change control management
- Project management
- Implementation of a Risk-Based Validation Program
Benefits
Benefits to using LexaMed Validation Services
- Highly qualified and experienced associates
- Reliable service
- Tailored to customer’s needs
- Cost effective
- Quality driven
- Adherence to FDA and other regulatory agency compliance
- Knowledge of current validation and compliance topics by keeping abreast through industry conferences by organizations such as IVT, ISPE, PDA and AAMI
- Ability to satisfy regulatory requirements enforced by various regulatory bodies which include ISO, MHRA, FDA, USP and EMEA
Medical Device & Pharmaceutical Validation Services
Validation Experience
LexaMed offers validation services in many aspects of the pharmaceutical and medical device industries, including process, product, facility, equipment and analytical methods. Projects have been scoped at more than US$15M and ranging in size from qualification of a single piece of equipment to complete turnkey validation of equipment, critical utilities, and greenfield projects for facilities located both domestically and internationally. Locations where we have operated include the United States, Puerto Rico, India, Australia, The Netherlands, Ireland, Denmark and Korea. LexaMed experienced associates are not only contemporary in industry knowledge but are also influential in establishing industry practice and regulatory expectations utilizing a risk-based approach.
Capabilities
Our team of validation associates has expertise in all aspects of pharmaceutical and medical device operations, including, but not limited to:
Process Equipment Qualification
►Qualification includes IQ, OQ, PQ, design qualification and impact assessment
involving a variety of equipment such as autoclaves, refrigerators, freezers,
environmental and stability chambers
Clean Room Qualification including automated controls systems (SCADA, BMS)
Qualification testing includes:
►HEPA filter leak testing
►Temperature and relative humidity mapping and monitoring
►Differential air pressure and direction tests
►Environmental monitoring
►Viable and non-viable particulate testings
Cleaning Validation Utilize equipment cleaning procedures to remove residues to levels of acceptability by:
►Establishment of residual limits and acceptance criteria
►Sampling selection
►Analytical method selection
Cleaning validation studies conducted via analysis and sample recovery methods include bioburden,
detergent residuals, drug substand/product residuals, protein. Equipments include blending tanks,
fillers and tablet compression, sonic cleaners, medical devices
and components.
Process Validation
►Validation of critical systems and processes in the manufacturing area which include aseptic
processing and clean room qualification to support manufacturing and processing of cytotoxic
injectables, lyophilization, solid dose forms, vials/ampules, bottles, and bags.
Product Validation
►Validation studies for solid dosage form, parenterals, and liquid products
Critical Utilities System Qualification
►Qualification includes systems such as HVAC, RO, WFI, Chillers and Isolators for utility and facility
start-up, commissioning, and re-commissioning
►Validation of compressed air and gases
Sterilization Methods
►Methods include EO, Steam, VHP, Radiation, UV, Ozone, Pulsed-Light, Dry Heat, Liquids, and Novel
Processes.
Analytical Methods
►Chemistry and Microbiology - method validation, verification and confirmation
►USP and customized methodologies, stability methods
►Method Transfers
