What It Is

NIS2 Directive (EU) 2022/2555 is an EU regulation replacing the original NIS Directive. It establishes a high common level of cybersecurity across member states, expanding scope to more sectors like energy, transport, and digital services. Applies to essential and important entities via size-cap rule (medium/large organizations). Employs a risk-based, all-hazards approach for resilience.

Key Components

• Four pillars: risk management, incident reporting, business continuity, corporate accountability.
• Strict reporting: 24-hour early warning, 72-hour notification, 1-month final report to CSIRTs.
• Continuous measures: supply chain security, access controls, encryption.
• Builds on standards like ISO 27001, NIST CSF; no formal certification but national enforcement.

Why Organizations Use It

• Mandatory compliance avoids fines up to 2% global turnover.
• Enhances cyber resilience against threats like ransomware, APTs.
• Builds stakeholder trust, ensures business continuity.
• Strategic benefits: harmonized EU-wide cooperation, competitive edge in critical sectors.

Implementation Overview

• EU states transpose by October 2024; 12-18 month grace periods in some.
• Targets medium/large entities in covered sectors EU-wide.
• Involves risk assessments, training, governance, audits.
• Proactive: dynamic registers, spot checks, board oversight. (178 words)

What It Is

Good Manufacturing Practice (GMP) is a regulatory framework establishing minimum standards for manufacturing controls in pharmaceuticals, biologics, and related products. Its primary purpose is to ensure products are consistently produced to quality criteria, preventing contamination, mix-ups, and variability through preventive systems rather than end-testing alone. It adopts a risk-based approach via Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
• Elements include quality management, personnel training, facility design, equipment validation, documentation, supplier controls, and continual improvement (CAPA, audits)
• Built on ICH Q9/Q10, FDA 21 CFR 210/211, EU EudraLex Volume 4, WHO GMP
• Compliance via inspections, no central certification but enforceable legally

Why Organizations Use It

GMP is mandatory for regulated industries to meet legal requirements, protect patients, avoid recalls/fines, and secure market access. It reduces risks, enhances efficiency, builds stakeholder trust, and supports global supply chains via harmonization (PIC/S, MRAs).

Implementation Overview

Phased approach: gap analysis, QMS design, validation (IQ/OQ/PQ), training, audits. Applies to manufacturers globally; intensive for pharma/biologics, scalable by size. Requires ongoing audits/inspections.