Sample Handling and Environmental Policy
GMP/FDA Compliant Sample Handling and EPA Compliant Sample Disposal
The chain of custody with regard to sample handling is a key component of clinical research. All samples at VCS are logged in a secure room with limited keypad access control.
Samples are documented, labeled, blinded (if requested), and logged in the Sample Handling room prior to distribution to respective lab departments.
The sample handling department has its own temperature and humidity control that follows Pharmacopeial standard practices for non-hazardous sample storage and retention.
Sample Reception and Submission
Please submit samples to:
Attn: Sample Reception
Validated Claim Support
400 Frank W. Burr Blvd.
Teaneck, NJ 07666
Client shall be solely responsible for all liability relating to or arising out of the sourcing, manufacturing, labeling, packaging, shipping, and supplying of products (the “Products”) for which VCS will perform certain claim validation services pursuant to separate agreements, purchase orders, or any other documents (the “Services”).
Representations and Warranties
Client represents and warrants that: (i) it has all corporate, limited liability, or other entity authority and power to enter into and perform its obligations under this Agreement; (ii) entering into and performing under this Agreement will not violate or conflict with any agreement to which Client is a party, or any judicial or arbitral order or judgment applicable to Client; (iii) it will strictly comply with all applicable state, federal, local, and foreign laws, statutes, rules, regulations, and ordinances, including, but not limited to, those promulgated by the United States Food and Drug Administration (“FDA”), the Fair Packaging and Labeling Act (“FPLA”), the United States Food, Drug and Cosmetics Act (“FDCA”), and those which regulate any raw material, components, or ingredients as an actual or potential danger to health, reproduction, or the environment, and those which regulate packaging, labeling, or contents of products (collectively, “Applicable Laws”); and (iv) it has and shall maintain in effect all licenses, permits, authorizations, and consents necessary to conduct its business.
Product Safety Testing
Client further represents and warrants that it has conducted and shall conduct all relevant and required safety testing, including, but not limited to, HRIPT, patch testing, toxicology testing, preservative efficacy testing, challenge testing, container and storage compatibility testing, and stability testing, to ensure that all Products are non-hazardous, bio-compatible, and non-irritating (“Product Safety Testing”). Upon VCS’ request, Client shall provide certificates evidencing the performance and successful completion of Product Safety Testing.
Client agrees to indemnify, defend, and hold harmless VCS, its affiliates, and their respective equity holders, directors, officers, employees, and agents (collectively each an “Indemnified Party”) from and against any and all claims, actions, causes of actions, judgments, costs, losses, liabilities, damages, or expenses, whether actual or alleged, including, but not limited to, reasonable attorney’s fees, court fees, interest, and penalties (collectively “Claims”), asserted against or incurred by an Indemnified Party relating to or arising out of the Products, including, but not limited to, any and all Claims relating to or arising out of (i) an alleged failure to adequately warn or label the Products with regard to exposure to substances contained in the Products; (ii) any claimed injury (including Claims arising from any challenged injury), illness, or death of any person or property damage which is caused or alleged to have been caused by the handling, application, consumption, or use of the Products (each an “Injury”), including, without limitation, any Injury arising during, or otherwise in connection with, the Services; (iii) any violation of Applicable Laws by Client, its employees, or agents, or (iv) any breach of the terms of this Agreement by Client, its employees or agents.
All controlled sample handling and retention areas are designed around International Pharmacopeial standards for temperature and humidity.
Access is restricted with keypads and combinations are updated regularly to ensure security in isolation.
Upon completion of a study, the minimum required amount of sample is retained by VCS for a period not to exceed 2 years (depending on the nature of the product). Samples returned by panelists are stored separately and earmarked for disposal.
If requested, samples can be returned to sponsor OR they can be marked for standard VCS Disposal.
Ethically and Environmentally Conscious Sample Disposal
VCS utilizes a third-party professional non-hazardous waste disposal service, and samples are clearly marked and labeled for destruction while stored onsite. Receipt of Disposal/Destruction is available on request upon completion, and VCS is committed to ensuring that samples are disposed of in an environmentally friendly fashion.
VCS currently uses Radiac Research Corp. as our official sample disposal partner.
Green Policies in Practice
At VCS we have implemented a number of policies that ensure we consider the well-being of the environment. We are committed to the following principles:
- We reuse and recycle all relevant materials wherever possible
- We employ management systems and procedures specifically designed to minimize the use of hazardous materials, energy, and other natural resources and to minimize the generation of waste
- We have installed LED, low voltage high efficiency lighting throughout the lab site
- Third party environmentally friendly Sample Disposal utilized (Radiac Research)
- We encourage our suppliers to adopt relevant environmental policy
- We will continually seek opportunities to improve our environmental performance by establishing objectives and targets, measuring progress, and reporting our results; including but not limited to energy, water, paper, and fuel consumption
- Our QMS and study documentation system is all digital, so physical printing is reduced by thousands of pages per week in comparison to competitors
- All waste is collected daily from the site via building management
- We communicate our commitment to responsible environmental management to staff members and contractors, and we will implement the necessary training and support to help them achieve these practices
- We can implement secondary controls and procedures at sponsor discretion