Pharmaceutical Industry and Compliance with U.S. FDA Regulations
In the United States, the Food and Drug Administration (FDA) serves as the primary regulator responsible for ensuring that the thousands of medicines sold in the country are safe and of the highest quality.
The FDA's Center for Drug Evaluation and Research (CDER) evaluates and approves all new drugs before they can be sold, provides health care professionals and the public with information about using medicines safely, and monitors existing drug products in the marketplace. Within the FDA, CDER has primary jurisdiction over the pharmaceutical industry.
Title 21 of the Code of Federal Regulations (21 CFR) contains a number of rules outlined by the FDA for the pharmaceutical industry throughout the various stages of drug discovery, research, manufacturing, and marketing. These regulations are well known in the pharmaceutical industry such as Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP) to name a few.
Pharmaceutical Industry and International Regulatory Bodies
The European Medicines Agency (EMA), the hub of 40 regulatory bodies that constitute the European Medicines Network, evaluates applications for new medicines and grants centralized marketing authorization for certain types of medicines. Drugs that don't fall under the EMA jurisdiction are evaluated by individual member states using their national authorization procedures.
National regulatory bodies in Europe include Germany's Federal Institute for Drugs and Medical Device (BfArM), the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA), and Switzerland's Swissmedic.
In Asia, Japan's Ministry of Health, Labour and Welfare (MHLW) enforces regulations affecting the pharmaceutical industry in that country, while the China Food and Drug Administration enforces the People's Republic of China's Drug Administration Law.
In addition to complying with rules enforced by national or regional regulatory bodies, pharmaceutical companies that compete in the global marketplace also typically comply with international standards such as the ICH Q10, a harmonized guidance for the pharmaceutical industry, the ICH E6 GCP Consolidated Guidance, and European Union GMP guidelines.
How MasterControl Can Help the Pharmaceutical Industry
Hundreds of pharmaceutical companies throughout the world use MasterControl quality and compliance software, an end-to-end solution designed to facilitate compliance with GxP regulations (FDA, MHRA, EMA, MHLW) and standards (ICH Q10, ICH E6 GCP, European Union GMP).
MasterControl provides an effective framework for a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a web-based, centralized location for all documents.
In addition to automation, MasterControl offers two key advantages:
- Mobile Access: MasterControl allows users to access information and perform tasks using a tablet or a smartphone. Mobile access offers greater flexibility for users and helps boost overall efficiency and productivity.
- Services: For companies concerned about the high cost of owning a QMS system, MasterControl offers cloud-based services. A cloud-based QMS system offers the same robust system in a secure environment without the need for a huge, up-front cost or a large IT staff. Companies can deploy faster using less resource.
MasterControl offers the following modules:
MasterControl Documents: For many pharmaceutical companies and CROs serving the industry, this module typically serves as a centerpiece for an effective QMS that greatly increases efficiency and productivity. It automates tracking, searching, retrieval, routing, review, and approval of documents. MasterControl can consolidate document management and document control with other quality processes such as training control, audit management, CAPA, and change control. MasterControl Documents is a highly configurable and flexible document management system that enables an organization to implement a single Electronic Document Management Solution (EDMS) throughout the enterprise while allowing each group to define its own level of securities and access control over its content.
MasterControl Process: Many pharmaceutical companies use MasterControl Documents and MasterControl Process together as their framework for a robust QMS. MasterControl Process automates any forms-based process and offers best-practice forms that prompt users with selected data to reduce data entry and avoid common data-entry mistakes. This module gives process designers the choice to configure all aspects of workflows, including users, tasks, tracking, escalation, and approval.
MasterControl Training: MasterControl Training automates distribution and monitoring of training tasks. It provides the capability for online grading of tests and sequencing of courses, so upon completion of a prerequisite course, the next course in the sequence will be automatically launched.
MasterControl CAPA: This module automates and streamlines the CAPA process by giving users the capability to launch a CAPA form from another form, such as customer complaints or non-conformances. Based on industry best practices, MasterControl's electronic 8D process will guide the quality team throughout the CAPA process, from root-cause investigation through implementation of preventive action.
MasterControl Audit: MasterControl Audit automates all audit-related tasks and schedules. It offers robust reporting tools and the capability to connect the audit management process with other critical quality processes.
MasterControl Supplier: This one-stop shopping solution integrates supplier management with the quality management system and provides a single repository for all supplier quality data and documentation. It allows users to create scorecards for effective evaluation of suppliers. It also provides robust tools for tracking and trending supplier quality events, such as deviations and SCARs.
MasterControl Regulatory Suite: This is a complete regulatory solution designed to manage all documents, project tasks, and electronic submissions by Regulatory Affairs functional areas. The suite includes MasterControl EDM JumpStart, based on the DIA EDM Reference Model, which is an industry best-practice standard for ensuring completeness of Common Technical Document (CTD) formatted submissions. It provides a CTD-centric project management tool, a versatile platform that allows the storage of fully functional published output (including external hyperlinks, bookmarks, and xml file navigation) generated by publishing tools, and a secure, web-based environment for all regulatory submissions.
MasterControl Clinical Suite: This is a complete clinical quality management solution designed to streamline clinical research processes by managing all documents, tasks, training, relationships, and audits throughout the clinical trial. The suite includes MasterControl TMF JumpStart, based on the DIA TMF Reference Model, which is an industry best-practice standard for ensuring completeness of clinical trial documentation. The suite also includes clinical quality forms to assist in the execution of clinical monitoring visits, clinical deviation, and clinical CAPA.
For More Information on MasterControl
To learn more about MasterControl solutions, contact a MasterControl representative