What It Is

CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation. It is a manufacturer's declaration that products meet essential health, safety, and environmental requirements. Scope covers categories like electrical equipment, machinery, and medical devices. Key approach is risk-based, using New Legislative Framework (NLF) modules A-H and OJEU-published harmonised standards for presumption of conformity.

Key Components

• Essential requirements from directives/regulations (e.g., LVD 2014/35/EU).
• Conformity assessment procedures (self-assessment or notified body).
• Technical documentation, EU Declaration of Conformity (DoC), and CE affixation.
• Post-market surveillance under Regulation (EU) 2019/1020. Compliance model is manufacturer-led self-declaration, with third-party verification for high-risk products.

Why Organizations Use It

Mandated for EEA market access; enables free circulation. Reduces trade barriers, ensures legal compliance, mitigates liability risks. Builds stakeholder trust, supports tenders, and leverages standards for efficiency.

Implementation Overview

Map applicable legislation, perform risk assessment, compile technical file, issue DoC, affix mark. Applies to manufacturers/importers in regulated sectors/EEA. No central certification; authorities audit files on demand. Typical for mid-large firms; 6-12 months with testing/notified bodies.

What It Is

Good Manufacturing Practice (GMP), also known as cGMP, is a regulatory framework of minimum enforceable standards for manufacturing pharmaceuticals, biologics, and related products. It ensures consistent production and control to predefined quality criteria via preventive systems spanning people, facilities, and processes. Core approach: risk-based with Quality Risk Management (QRM) and lifecycle Pharmaceutical Quality System (PQS).

Key Components

• **5 Ps pillarsPeople (training/hygiene), Premises (facility design), Processes (validation), Procedures (SOPs/documentation), Products (materials control).
• Over 100 requirements across FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, WHO GMP.
• Principles: independent quality oversight, data integrity (ALCOA+), continual improvement (CAPA).
• Compliance via regulatory inspections, no universal certification.

Why Organizations Use It

• Mandatory for market access, averts recalls/liability.
• Drives efficiency, supply reliability, global harmonization (ICH/PIC/S).
• Builds patient safety, stakeholder trust, competitive edge.

Implementation Overview

Phased: gap analysis, Validation Master Plan, qualification/training, audits. Suits all pharma sizes/industries globally; demands ongoing inspections. (178 words)