What It Is

Good Manufacturing Practices (GMP), including FDA 21 CFR Parts 210/211 and EU EudraLex Volume 4, is a regulatory framework establishing minimum standards for manufacturing controls. It ensures products like pharmaceuticals are consistently produced to quality criteria through preventive systems spanning people, premises, processes, and documentation. Core approach is risk-based via Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Key Components

• **5 PsPeople, Products, Procedures, Processes, Premises.
• Independent Quality Control Unit or Qualified Person (QP) oversight.
• Dozens of requirements across subparts like facilities, equipment, validation, records.
• Built on ICH Q9/Q10 principles; compliance via inspections, no central certification.

Why Organizations Use It

Mandated for market access in pharma/biologics; prevents recalls, contamination, mix-ups. Reduces liability, enhances supply reliability, builds stakeholder trust. Strategic benefits include efficiency, innovation enablement, global harmonization via PIC/S/ICH.

Implementation Overview

Phased: gap analysis, Validation Master Plan (VMP), training, qualification (IQ/OQ/PQ), audits. Applies to manufacturers globally; high complexity for pharma facilities. Ongoing via CAPA, management review; enforced by regulators like FDA/EMA.

What It Is

ISO 13485:2016, titled Medical devices – Quality management systems – Requirements for regulatory purposes, is an international certifiable standard establishing a risk-based QMS framework. It ensures organizations consistently meet customer and regulatory requirements across medical device lifecycles, from design to post-market surveillance.

Key Components

• Core clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
• Emphasizes validation, traceability, risk management (per ISO 14971), supplier controls, and medical device files.
• Built on process approach; requires documented procedures, records, and objective evidence.
• Certification model: accredited bodies conduct stage 1/2 audits, surveillance, recertification every 3 years.

Why Organizations Use It

• Facilitates market access (EU MDR, FDA QMSR 2026 alignment).
• Mitigates risks of recalls, non-conformities, liabilities.
• Enhances operational efficiency, supply chain resilience, stakeholder trust.
• Provides competitive differentiation via certification.

Implementation Overview

• Phased: gap analysis, documentation (eQMS), training, validation, internal audits.
• Applies to manufacturers, suppliers, distributors globally.
• 12–18 months typical; focuses on CAPA, design controls, post-market processes.