Biotech Industry: Life Science Sector and Compliance
The United States is the single most active developer of innovative medicines, with 3,500 new compounds being studied in this country. The Food and Drug Administration (FDA) oversees and enforces regulations that pertain to biopharmaceutical companies, biotech device companies, and organizations that manufacture combination products.
FDA regulations that apply to those companies stem from the Food, Drug, and Cosmetic Act. Biopharma and other life science biotech companies must comply with rules and guidances that pertain to their new drug application (NDA) or biologics license application (BLA) or new molecular entities (NME) or premarket approval (PMA) for novel medical devices.
Life science manufacturers in the U.S. biotech industry must comply with different sets of standards and regulations according to the product development stage they are in. In general they must comply with the following FDA regulations:
- Preclinical Research: Good Laboratory Practice (GLP) regulations and guidances.
- Research: Good Clinical Practice (GCP) regulations and standards.
- Stage: Good Manufacturing Practice (GMP) requirements.
Biotech Industry: Non-Life Science Sector and Compliance
Biotech companies that are not engaged in developing life science products and services, such as food and energy companies, are also highly regulated. Their products impact millions of people worldwide. Just like their counterparts in the life science biotech industry, these companies must ensure safe and high-quality products.
Food Industry: The Food Safety Modernization Act (FMSA) essentially overhauled the food safety system and significantly expanded the FDA's enforcement power over the food industry. Under this law, the FDA has the authority to order a recall of food products. Before this law, the FDA had to rely on the industry to recall harmful foods voluntarily.
The U.S. Department of Agriculture (USDA) is the primary authority for certain sectors of the food industry, namely companies involved in selling and distributing meat, poultry, and egg products. The USDA and the FDA are among the federal agencies responsible for regulatory oversight of the safety network for food and agricultural biotech products.
Energy Industry: The energy industry, which is overseen by the U.S. Environmental Protection Agency and the Federal Energy Regulatory Commission, typically complies with ISO 9001 and ISO 14001 standards, both of which are voluntary standards used throughout the world.
ISO 9001 standards for general manufacturers and other businesses set the international criteria for quality management systems. ISO 14001 standards focus on managing a company's impact on the environment.
How MasterControl Can Help the Biotech Industry
MasterControl is a leading provider of software solutions and services that enable companies in the biotech industry to get their products to market faster, while reducing overall costs and ensuring regulatory compliance. MasterControl quality and compliance software manages a company's quality information and processes throughout the entire product lifecycle.
If you belong to the biotech industry, MasterControl can help you attain the following:
Standardization through Automation: MasterControl will automate all document- and forms-based processes, which in turn will standardize the recordkeeping and documentation process. All stakeholders will be able to find the latest documents and information in one place: a secure, centralized web-based system, which will make searching, tracking, and retrieval easier.
Efficiency and Flexibility: MasterControl is web-based, which means users will be able to perform tasks virtually anywhere, anytime-greatly improving overall efficiency. With MasterControl Mobile, your users don't need to be in front of a computer to perform their tasks. This kind of flexibility is critical if your company's employees and operations are scattered in various locations and require high team coordination, or if your employees are out in the field.
Connected Processes: MasterControl connects all stakeholders by integrating different processes (e.g., CAPA, audit, change control, etc.) that could impact product quality under a single system. An integrated system reduces the risk that quality issues will fall through the cracks by bringing all departments together under one platform for a holistic approach to compliance.
Improved Processes: MasterControl's Quality and Compliance Consulting Team can help you improve your existing quality processes by identifying their strengths and weaknesses. MasterControl consultants can help you turn your individual processes into a cohesive, closed-loop quality system that will help ensure compliance.
Inspection Readiness: With MasterControl, all critical processes and documentation will be in one place and visible to auditors and inspectors. MasterControl provides a platform and a structure that makes compliance easier to manage on a daily basis-giving you the peace of mind and confidence that your organization is always ready for an audit or inspection.
Lower Compliance Costs: The combination of an electronic quality system's increased efficiency and accelerated compliance can dramatically lower your overall compliance costs. To help ease the financial burden of switching from inexpensive paper or hybrid systems to a fully automated system, MasterControl offers cloud-based services, which provides the same robust system in a secure environment without the need for a huge, up-front cost of an on-premise quality system.
For More Information on MasterControl Software for the Biotech Industry
To learn more about how MasterControl quality and compliance software can help companies in the biotech industry, contact a MasterControl representative.