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FDA Compliance

Adopt a Configurable, Risk-Based Quality and Compliance Management Program

The FDA attributes paramount importance to pharmaceutical manufacturing and product quality. Its recent initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach", focuses especially on GMP enforcement on high-risk products. This approach endorses the adoption of advanced and innovative manufacturing technology, and high quality and safety of drugs through sound and consistent policies. While the new initiative also applies to medical devices and biotechnology sector, the Good Laboratory Practice (GLP) guides laboratories, and the Good Clinical Practice (GCP) pertains to the quality and performance of clinical environments.

FDA regulations set a standard which can be enforced by administrative and judicial actions such as issuing warning letters and 483 notices, product recalls, license revocations, civil money penalties, and even criminal prosecutions against violators.

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MetricStream FDA Compliance Management Solution

The regulations pertaining to the life sciences industry are codified in the Congressional Federal Register (CFR) under Title 21, which comprises nine volumes and includes section 1 to 1499.

A few significant sections pertinent to the life sciences industry are:

  • 21 CFR Part 11: It covers the practices, procedures and requirements relating to administration, computer technology, reporting and record keeping
  • 21 CFR Part 210: It lays down rules and guidelines for packaging drugs and containers
  • 21 CFR Part 211: It lists out the mandates on labeling drugs, packaging laboratories and containers, prescription drugs, reporting and recordkeeping , and warehouses
  • 21 CFR Part 600: It refers to the requirements in reporting and recordkeeping of biologics
  • 21 CFR Part 820: It defines the requirements for reporting and recordkeeping of medical devices

The guidelines and procedures for producing quality, effective and safe pharmaceutical and medical devices products have also been laid down by the FDA under the Current Good Manufacturing Practices (CGMPs).

The FDA has intensified its scrutiny of the life sciences industry in the light of the current bioterrorism fears.  The key is to adopt FDA regulations as a cornerstone to implement a configurable, risk-based quality and compliance management program.

MetricStream enables companies to adopt a risk-based approach to managing quality and FDA GXP compliance. The solution provides a common framework and an integrated approach to meet FDA GXP regulations through risk management, document control, compliance training, ongoing auditing, and recording and reporting of exception events and the resulting corrective actions.

The solution automates GXP compliance processes, and provides embedded best practices for ensuring ongoing compliance with FDA regulations. It also improves operational efficiencies in quality systems, thereby lowering the cost of regulatory compliance. In addition, it facilitates a transparent environment for proactively identifying, tracking, and resolving quality issues.

MetricStream uniquely combines software and content to deliver solutions for effective and sustainable FDA GXP compliance. The solution also offers access to training content from an expert community, and enables integration of business processes with regulatory notifications or industry alerts.

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