Regulations and Standards For Life Sciences Overview

FDA 21 CFR Part 11

“Part 11,” as it is commonly called, is the section of Title 21 of the United States’ Code of Federal Regulations that describes the FDA’s regulations on electronic records and electronic signatures. It outlines the conditions under which electronic records and signatures can be judged to be dependable and comparable to paper records. As such, it requires life sciences and other FDA-regulated industries to implement controls on software systems that are involved in processing and managing quality data. To learn more about FDA 21 CFR Part 11 and how MasterControl can help your company with compliance to it and to similar regulations, click here.

FDA 21 CFR Part 111

Specific to dietary supplements, Part 111 represents the FDA’s regulatory requirements for current good manufacturing practices (cGMPs). The final rule on Part 111 was established in 2007 in an effort to ensure that any foreign or domestic company that manufactures, packages, labels or holds dietary supplements implements proper controls. Such controls are in place for dietary supplements and ingredients with an expectation that they will be processed in a consistent manner (i.e., consistency in regards to identity, purity, strength and composition) and that they will meet the anticipated standard of quality.

FDA 21 CFR Parts 210-211

All pharmaceutical manufacturers need to be keenly aware of the particulars of FDA 21 CFR Parts 210-211. These regulations mandate that all drugs need to be made according to current good manufacturing practices, or cGMPs, which are intended to provide an assurance that companies have sufficient design, monitoring and control of manufacturing processes and facilities. Parts 210-211 are generally applicable to drug makers’ processes that involve the manufacturing, processing, packing, or holding of drugs intended for human consumption. According to the FDA, adherence to these regulatory guidelines helps assure the identity, strength, quality and purity of drug products.

FDA 21 CFR Part 820

Medical device manufacturers are intensely scrutinized by the FDA to ensure their products are safe and suitable for their intended use. The guidelines set forth in 21 CFR Part 820 are focused on the establishment of quality systems that safeguard manufacturers’ medical devices from inconsistency. The Part 820 quality systems regulation affords an “umbrella” approach to current good manufacturing practices (cGMPs) in that it provides a basic framework of guidelines within which manufacturers are allowed to fill in appropriate processes and procedures specific to their devices. To learn more about Part 820 and how MasterControl can help you comply with the regulation, click here.

FDA 21 CFR Parts 1270-1271

Organizations that deal with human cells, tissues and cellular- and tissue-based products are subject to FDA 21 CFR Part 1270-1271. These products, also known as HCT/Ps, are frequently used in life-saving medical procedures. The FDA enforces Good Tissue Practices (GTP) through the administration of Part 1270-1271 with the intention of guaranteeing the safety of HCT/Ps and preventing the introduction, transmission and spread of communicable diseases.

FDA 21 CFR Part 606

For the purpose of designating that blood and blood components are safe, pure and effective, the FDA has outlined the current good manufacturing practices (CGMPs) for blood establishments in 21 CFR Part 606. It provides guidelines for blood establishments’ facilities, processing procedures, compatibility testing, distribution methods, controls and more. Part 606 includes the accountabilities of the personnel involved in the aforementioned activities as well. To learn more about Part 606 and how MasterControl can help your company with compliance, click here.

ISO 9000

Perhaps the most widely known of the ISO family of standards, ISO 9000 provides direction in regards to general manufacturing and service organizations’ quality management and quality assurance systems. The Technical Committee (TC) responsible for ISO 9000 is TC 176. Many companies consider the standard to be the ultimate guide to excellence in product, service and management quality. In fact, there are approximately 350,000 companies throughout the world that are certified to the standard.

ISO 9001

The ISO 9001 quality management standard was originally published in 1987 and has continued to evolve since then. While process management has always been a core focus of the standard a greater emphasis has recently been placed on risk management and outputs than initially appeared in its first publication. With the recognition that quality demands are becoming increasingly more complex and challenging, ISO 9001 serves as a common means of communicating fundamental quality management system requirements to organizations of all sizes, types and industries. As is the case with organizations pursuing certification to any evolving standard, companies that seek adherence to ISO 9001 should continually evaluate their existing quality management systems for potential improvements and efficiencies.

ISO 13485

The primary intent of ISO 13485 is to create a unified global structure for medical device quality management in the international market. As such, compliance with the ISO 13485 guidelines requires that medical device manufacturers establish quality systems and procedures that are adequately documented, controlled and maintained. To stay competitive in a flourishing global medical device market, more and more manufacturers are abandoning inefficient paper-based quality management systems in favor of more robust and effective automated systems. In doing so, they are better able to meet customer needs and industry expectations.

ISO 14000

A family of international standards dedicated to environmental management, ISO 14000 provides a basic structure for the development of environmental management systems and the audit methodology behind such programs. ISO 14001, the cornerstone of the series of standards, offers criteria for the certification of environmental management systems. However, it serves as more of a general structure rather than a specified set of performance requirements. The intended befits of ISO 14000 include reduced waste, lowered costs, energy savings and enhanced corporate image.

ISO 14971

Medical device manufacturers must establish risk management processes that allow them to identify hazards, and evaluate and plan for risks, and to develop, implement and track the effectiveness of risk control measures. The internationally recognized standard for medical device companies’ risk management practices if ISO 14971. This risk-focused standard is particularly useful in helping medical device companies effectively manage vital documentation throughout a device’s lifecycle.

ISO 15189

With an aim toward promoting the harmonization of medical practices around the world, ISO 15189 outlines the requirements for quality and competence that are specific to medical laboratories. The standard is intended to protect the health and safety of both patients and healthcare providers. It supports the efficient exchange of information and protection of data, and also enhances the general quality of care. Laboratory clients, regulatory authorities, and accreditation organizations rely on ISO 15189 to ensure competence. The version of the standard updated in 2012 contains technical and quality management system requirements.

ISO/TS 16949

Based on existing German, French, Italian and United States standards, ISO/TS 16949 is a technical specification that globally aligns automotive quality system requirements under a single standard. It identifies quality system requirements for the design, development, installation, production and servicing of automotive products. Developed by the International Automotive Task Force (IATF), the technical specification encourages improvement in supply chain and certification processes. TS 16949 certification is a mandatory prerequisite to doing business for the majority of automobile manufacturers throughout the world. The specification is pertinent to all types of companies that supply automotive-related products, whether they are small manufacturers or multinational companies with multiple sites located across the globe.

CLIA

Clinical laboratories that implement web-based software solutions are able to save valuable resources and time but they must be able to demonstrate that their quality systems are safe and effective. The Clinical Laboratory Improvement Amendments (CLIA) were established to regulate and provide quality assurance of human specimens in clinical laboratory environments in order to ensure accurate and reliable test results. Approximately 244,000 laboratory entities are subject to CLIA regulations, which are directed by the Centers for Medicare & Medicaid Services (CMS). To learn more about how the CLIA program applies to your organization and how MasterControl can help with laboratory compliance, click here.

カナダ規格

The Standards Council of Canada (SCC), representing Canada as a member of the International Organization for Standardization (ISO), directs the country’s involvement in the ISO 9000 family of quality system management standards. The SCC also participates in international agreements intended to ensure foreign acknowledgement of Canadian management system certification. While Canadian quality standards do not provide conformity assessments, they are applied to the accreditation of certification bodies that conduct third-party assessments. Canadian quality standards are intended to support regulatory guidelines, ensure the safety of products sold to Canadian consumers, and help Canadian companies enrich their competitiveness throughout the world.

EU Annex 11

Different regulations specifying compliance standards for electronic quality systems apply to different regions of the world. Just as FDA 21 CFR Part 11 institutes compliance standards for ensuring the integrity of electronic records and data for the United States, EU Annex 11 applies similar standards to the European Union as well as to any foreign manufacturers that are seeking EU market approval. Unlike Part 11, however, Annex 11 is a recommended guideline and not a legal requirement. The scope of Annex 11 relates to good manufacturing practices (GMP) for medicinal products intended for human use, investigational medicinal products for human use and veterinary medicinal products. For additional information about how Annex 11 concerns computerized systems used in GMP environments and how MasterControl software can help facilitate compliance, click here.

GxP

GxP is a general term that refers to Good Practice quality guidelines and standards such as Good Clinical Practice, Good Manufacturing Practice, Good Clinical Practice and so forth. Manufacturers in a variety of industries are acutely familiar with the term and the requirements of GxP quality standards. More and more frequently manufacturers are turning to electronic quality management systems to better meet the demands of GxP regulations and maintain a competitive edge in the global marketplace. Electronic quality management systems can dramatically streamline GxP compliance and subsequently get manufacturers’ products to market sooner.

GAMP® 5

GAMP® 5 is the most current iteration of the Good Automated Manufacturing Practices defined by the International Society for Pharmaceutical Engineering (ISPE). The principles and procedures set forth in GAMP® 5 help ensure that automation equipment meets quality standards. Quality by design (QbD), one of the fundamental directives of GAMP® 5, advocates that quality should be built into each stage of the manufacturing process. Compliance with GAMP® 5 standards provides an assurance that manufacturers’ machines are designed and constructed within an all-inclusive total quality management system. GAMP 5 compliance requires methodical process steps, rigorous testing and accurate documentation in order to validate specifications. To find out how MasterControl software solutions can help your organization facilitate GAMP 5 compliance, click here.

508 Compliance Standards

To address access issues for people with physical, sensory, or cognitive disabilities, the standards outlined in Section 508 of the Rehabilitation Act stipulate the technical criteria specific to various types of technologies and performance-based requirements that focus on functional capabilities of covered products. The criteria cover software applications and operating systems, web-based information and applications, computers, telecommunications products, video/multi-media and self-contained closed products. U.S. federal agencies have an explicit statutory obligation to ensure that all electronic and information technology (EIT) that is used, developed, maintained or procured is compliant with Section 508. To meet and exceed the expectations of Section 508 standards, MasterControl has invested hundreds of man hours to design the most clickable, navigable and touchable quality management system software on the market. To learn how your company can use MasterControl to comply with Section 508 accessibility standards, click here.

FDA 510(k) and PMA Submissions

Prior to marketing a medical device, manufacturers must demonstrate to the FDA that the device to be marketed is safe and effective. New devices must be categorized and proven to be substantially equivalent to a legally marketed device that is not subject to premarket approval (PMA). To ensure such conditions are met, Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market such devices at least 90 days in advance. Given these rules, device manufacturers must first implement sufficient quality and change control practices in order to receive 510(k) clearance without any stumbling blocks. Inexact communication about device changes or modifications can have a significant negative impact on product safety and/or effectiveness and will likely slow the time it takes to get the product to market.

PMDL (Japan)

Japan’s medical device market authorization process has historically been considered one of the lengthiest and most rigorous in the world. Presently, even though regulations are still stringent, the Pharmaceutical and Medical Device Law (PMDL) that went into effect in November 2014 is intended to streamline Japanese regulatory requirements for medical devices. The PMDL replaces the Pharmaceutical Affairs Law (PAL), the prior mandate for medical device registration requirements in Japan. The goal of the PMDL is to make the process even faster than that of the U.S. FDA. Quick access to safe and effective medical devices and diagnostics is of particular importance since Japan represents the second largest market for medical technology products in the world.

PIC/S

PIC/S is an acronym used to describe two groups operating in parallel in the GMP (Good Manufacturing Practice) field: the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme). The PIC Scheme is a cooperative arrangement between the health authorities of various nations that seeks to continue and enhance the work of PIC, which is a formal treaty and has legal status. Since PIC/S standards are now applicable to Japanese markets, many pharmaceutical companies that serve those markets are turning to electronic quality management solutions like MasterControl to maintain PIC/S compliance.