Regulatory Compliance

As a responsible player in the life science and healthcare product manufacturing and services industry, BioChain adheres to various regulations that govern our quality operations and processes. Our laboratory is compliant to the OSHA and BioSafety Level II standards. Our manufacturing facility is registered under the ISO 13485:2016 & ISO 9001:2015. Our sample collection and handling process conforms to GCP regulations with the IRB process and informed patient consent forms being required for each sample. We are building the next level of compliance into our facilities and processes as we continue to move towards clinical diagnostic application development.

BioChain has established an Institutional Review Board (IRB) compliant to 45 CFR part 46, 21 CFR part 56.

The IRB is registered with the Office for Human Research Protections(OHRP) with the registration number of IRB00008283.

When handling biomaterials and related patient information, BioChain complies with the relevant regulations from the various governing bodies.

This includes the regulations on Good Clinical Practice (GCP) from the FDA, the Handbook For Good Clinical Research Practice from World Health Organization (WHO), and the Guideline for Good Clinical Practice from The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Good Clinical Practice includes approval of the protocol by the Investigation Review Board (IRB), the informed consent form for donors or participants, confidentiality/privacy of related information, and quality assurance in the process.

BioChain has registered with the Office of Diversion Control for using materials in Schedule II Narcotic, Schedule II Non Narcotic, Schedule III Narcotic, Schedule III Non Narcotic, and Schedule IV. Office of Diversion Control in Drug Enforcement Administration (DEA) is a component of the U.S. Department of Justice

BioChain has registered with the Environmental Protection Agency (EPA) and participates in the EPA program for protecting human health and environment.

The EPA is an agency of the federal government of the United States charged with protecting human health and the environment.

The agency is led by its Administrator, who is appointed by the president and approved by Congress.

BioChain has obtained the appropriate permits from the United States Department of Agriculture (USDA), the United States Fish and Wildlife Service (USFWS), the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), and the Centers for Disease Control and Prevention (CDC) for import and export of products to its customers.

BioChain has implemented the compliance procedures to legally import and export a variety of biomaterials from different species of organisms for research and development.

BioChain strictly adheres to all regulatory requirements when performing work involving bio-hazardous materials. All laboratory personnel are trained and proficient in Biosafety Level 2 practices. This includes regulations, guidelines and recommendations from DHHS, CDC, NIH, OSAH, and State authorities. Our high standards ensure the safety of our personnel and also prevent unwanted contamination of the final products.

BioChain has established facility and operating procedures compliant with OSHA Regulations (Standards – 29 CFR) Occupational exposure to hazardous chemicals in laboratories. – subpart 1910.1450.

Biochain is assessed annually by NSF-ISR to ensure compliance under ISO 13485:2016 & ISO 9001:2015 standard.

BioChain has also implemented and maintains a Quality Management System, which fulfills the requirements of the ISO 9001:2015.

International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations.

The organization promulgates worldwide proprietary, industrial and commercial standards.

BioChain is in the process of establishing compliance with more regulation requirements, including GLP, CLIA/HIPPA/PSQIA, and cGMP.

The Good Laboratory Practice (GLP) is the FDA regulation for non-clinical research. CLIA/HIPAA/PSQIA stand for Clinical Laboratory Improvement Amendments/The Health Insurance Portability and Accountability Act of 1996/The Patient Safety and Quality Improvement Act of 2005.

These are the DHHS regulations for clinical diagnostic services. The cGMP stands for current Good Manufacturing Practice, which is the FDA regulation for manufacturing products for clinical usage.