Biometics, LLC

Biometics
Biometics Design-Construction

Biologics • Pharmaceuticals • Specialty Chemicals • Medical Devices

CGMP/Regulatory Compliance

Audits to review the requirements of CGMP are completed during design, engineering and construction of facilities for licensed manufacturing. These audits focus on:

Segregation
Containment and Isolation
Flow of Materials, Personnel, Product, Glassware and Waste
HVAC Zoning, Pressurization and Filtration
Clean Utilities
Drain and Exhaust Systems
Aseptic Processing
Cleaning and Decontamination
Spill Containment
Validatability
Documentation

CGMP/Validation

Validation Document Preparation and Execution

Biometics is able to provide all or part of the following validation program management services to complement the client's in house capabilities:

Integrate the validation activities into the design and construction schedule to shorten the overall timeline to completion.
Maintain the schedule, that is, to coordinate the efforts of the team relative to changes in the project in order to meet time and budget goals.
Design and Implement Documentation Systems
Design and Implement Metrology Programs

Validation Document Preparation and Execution

Biometics provides complete validation of facilities, operating utilities, processing equipment and process. A full validation program includes:

Master Validation Plan

Summary of the philosophical approach and rationale

Summary of the methodology and techniques

Validation planning worksheet identifying individual tasks

Flow diagrams showing personnel, product and waste

List of available resources, internal and external

Resource leveling method schedule to project the time required for the project based on the available resources

Biometics combines the Master Validation Plan with the construction schedule to ensure that:

Validation is a focus of the total effort.

Documentation is available as necessary.

Validation documents are prepared concurrently with construction.

The overall time to complete validation is minimized.

Validation Protocol Preparation:

Installation Qualifications

Operational Qualifications

Performance Qualifications

Standard Operating Procedures (SOPs) for operation, maintenance, cleaning and sanitization
Validation Protocol Field Execution/Data Collection
Final Reports