What It Is

Good Manufacturing Practices (GMP/cGMP) are legally enforceable regulatory frameworks, such as FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP, establishing minimum standards for manufacturing controls. Primary purpose: ensure products like pharmaceuticals and biologics are consistently produced to quality specifications via preventive systems, not end-testing alone. Key approach: risk-based with Quality Risk Management (QRM) and lifecycle controls.

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
• Elements: Pharmaceutical Quality System (PQS), validated processes/equipment, documentation, training, audits, CAPA
• Built on ICH Q9/Q10 principles
• Compliance via inspections, no central certification but enforcement through warnings/recalls

Why Organizations Use It

Mandated for market access; reduces recalls/liability, ensures supply reliability. Strategic benefits: operational efficiency, patient protection, global harmonization via PIC/S/ICH. Builds regulator/stakeholder trust.

Implementation Overview

Phased: gap analysis, Validation Master Plan, facility qualification, SOPs, training. Applies to pharma/biologics manufacturers globally; requires ongoing audits/self-inspections.

What It Is

The Federal Information Security Modernization Act (FISMA) is a U.S. federal law enacted in 2014, modernizing the 2002 act. It mandates risk-based security programs for federal agencies and contractors to protect information and systems' confidentiality, integrity, and availability using the NIST Risk Management Framework (RMF).

Key Components

• NIST RMF 7-step process: Prepare, Categorize, Select, Implement, Assess, Authorize, Monitor.
• NIST SP 800-53 controls (hundreds, baselined by FIPS 199 impact levels: low/moderate/high).
• Continuous monitoring, System Security Plans (SSPs), Authorization to Operate (ATO), annual Inspectors General (IG) assessments.
• Metrics aligned to NIST Cybersecurity Framework functions; no central certification.

Why Organizations Use It

• Mandatory for federal entities/contractors handling federal data.
• Reduces breach risks, enables contracts, enhances resilience/efficiency.
• Builds stakeholder trust, competitive edge in federal markets.

Implementation Overview

Phased RMF application: inventory assets, categorize systems, deploy controls, assess/authorize, sustain monitoring. Targets federal agencies/contractors; suits all sizes but resource-intensive with ongoing audits/reporting. (178 words)