For every 5,000 to 10,000 experimental compounds considered by the U.S. Food and Drug Administration (FDA), it is likely that only one will be approved by the agency, according to the Pharmaceutical Research and Manufacturers of America. Given the high odds against a new drug’s approval, pharmaceutical companies face tremendous pressure in making sure that their submissions are compliant. A pharmaceutical quality management system is a basic requirement and a critical element of regulatory compliance.
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Under 21 CFR Part 211, pharmaceutical companies are required to establish and maintain a quality control unit, which is responsible for a company’s quality management system. An essential part of a pharmaceutical quality management system is documentation (procedures, SOPs, policies, etc.) and controlling all documents that impact product quality and safety.
In addition, pharmaceutical companies also must comply with 21 CFR Part 11, a regulation that applies to all FDA-regulated companies. Its overall goal is to allow the use of electronic records as much as possible, but at the same time ensure product quality. A pharmaceutical quality management system should cover these critical aspects of Part 11: electronic records and electronic signatures, audit trails, validation, copies of records, and record retention.
Pharmaceutical companies under the jurisdiction of the European Medicines Agency (EMA) are required to establish and implement an effective pharmaceutical quality management system in order to comply with GMP. The requirement can be found in Article 6 of Directive 2003/94/EC and Directive 91/412/EEC.
The EMA adopted ICH Q10, which provides an example of a pharmaceutical quality management system designed for the entire product lifecycle. Under ICH Q10, a pharmaceutical quality management system must have these four elements: process performance and product quality monitoring system; CAPA system; change management system; and management review of process performance and product quality.
MasterControl quality and compliance software is an end-to-end solution that automates any paper-based or hybrid pharmaceutical quality management system and connects all quality and other critical processes to help accelerate compliance and time to market.
Here are some of the features of MasterControl that makes it an ideal platform for your pharmaceutical quality management system:
FDA Submission Templates: The system provides appropriate templates for NDA, BLA, CTD, and IND submissions to streamline document formatting and the dossier-creation process.
Virtual Workspace for Collaboration: A virtual workspace for collaboration is a critical component of a pharmaceutical quality management system, especially for global companies with geographically dispersed stakeholders. The system automates tasks related to cross-functional collaboration, including routing of documents, follow up, escalation, and approval.
Automated PDF File Generation: The FDA requires all electronic submissions to be in PDF format. MasterControl offers automatic PDF conversion of all documents, greatly increasing efficiency because users won’t have to generate PDF documents manually.
Centralized, Web-Based Repository for Documents: Using MasterControl as the platform for your pharmaceutical quality management system means you will have a single, centralized location for all of your submissions and critical documents. MasterControl is web based so your users and stakeholders will be able to access the system at any time from virtually anywhere.
Document Management Submission Tools: MasterControl offers robust tools for creating and publishing submission-ready documents early in the pre-clinical and clinical phases of the study.
Electronic Signatures: Under 21 CFR Part 11, the FDA specifies what it requires of an electronic pharmaceutical quality management system as far as electronic signatures are concerned. MasterControl addresses all FDA requirements, including signature manifestations that show the name, date, time, and meaning of an electronic signature.
Cloud Services: For small companies with limited funds to invest in an electronic pharmaceutical quality management system, MasterControl provides cloud services. A cloud-based pharmaceutical quality management system offers the same robust and secure QMS without the large upfront cost of owning a system, the required IT infrastructure, and without the need to hire a full IT staff.
Please feel free to contact us about questions you may have about Pharmaceutical Quality Management.