Validation Services & Solutions
BGF consultants possess hands on experience developing and implementing compliant Validation programs for various sized business across a range of product types in the regulated industries. Our approach to validation systems allows your organization to meet regulatory requirements and expections, while providing a cost effective and sustainable program. Utilizing a risk based approach; our consultants can help you achieve your internal requirements and regulatory mandates, while providing efficient and robust validation solutions.
Validation Master Plan
This overriding plan is the foundation of a validation program and details your company’s approach to validation management and compliance. The plan s tailored to achieve the appropriate levels of qualification activities for your organizations’ products and processes.
DQ, IQ, OQ, PQ: Whether at the beginning stages of equipment purchase and design, or implementation and qualification of laboratory or manufacturing equipment; BGF experts can design, implement and qualify equipment for use in your operations.
Cleaning Validation Program
Cleaning procedures and their suitability are a must to ensure the safety and purity of drug products and medical devices. BGF can provide the expertise your organization needs to meet regulatory scrutiny and provide sound, effective procedures for your team.
Developing, identifying and qualifying the critical process parameters of your manufacturing process allows for a smooth transition from technology transfer to commercialization. BGF can assist your team in designing a robust an efficient operation that meets regulatory requirements.
BGF consultants have experience developing and qualifying a broad breadth of Environmental Monitoring programs; including traditional classified clean rooms, aseptic and advanced aseptic processing, potent compounds and biologics.
Our consultants offer Sterility Assurance program development for aseptic filtration, steam in place, gamma, ETO, and steam sterilization, as well as depyrogenation.
Facility & Quality Qualification
From design review to commissioning and qualification; BGF’s consultants provide essential knowledge to expedite the commissioning, qualification and acceptance of your organization’s facilities and utilities.