What It Is

Good Manufacturing Practice (GMP), including FDA 21 CFR Parts 210/211 cGMP, is a regulatory framework establishing minimum standards for manufacturing controls in pharmaceuticals and biologics. Its primary purpose is preventive quality assurance across people, premises, processes, and documentation to ensure product identity, strength, purity, and safety without relying solely on end-testing. It employs a risk-based approach via ICH Q9 QRM and lifecycle systems like ICH Q10 PQS.

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
• Key areas: personnel training, facility/equipment validation, material controls, documentation (SOPs, batch records), CAPA, audits
• Built on ALCOA+ data integrity, QRM, and continual improvement
• Compliance via inspections, no central certification but enforceable by regulators (FDA, EMA, WHO)

Why Organizations Use It

GMP is legally mandatory for market access, preventing recalls and liabilities from historical tragedies like Elixir Sulfanilamide. It reduces risks, ensures supply reliability, builds stakeholder trust, and enables global harmonization via PIC/S and ICH.

Implementation Overview

Phased approach: gap analysis, Validation Master Plan, training, qualification (IQ/OQ/PQ), eQMS deployment. Applies to pharma/biologics firms globally; requires ongoing audits and management review. (178 words)

What It Is

ISO 19600:2014 — Compliance management systems — Guidelines — is a Type B guidance standard from the International Organization for Standardization. It provides recommendations for establishing, developing, implementing, evaluating, maintaining, and improving a Compliance Management System (CMS). Applicable to all organization sizes and sectors, it adopts a risk-based, proportionate approach integrated with existing frameworks like ISO 9001.

Key Components

• 10 clauses mirroring Annex SL structure: context, leadership, planning, support, operation, performance evaluation, improvement.
• Core principles: good governance, proportionality, transparency, sustainability.
• Focuses on risk assessment, obligations identification, controls, training, monitoring; non-certifiable benchmarking tool.

Why Organizations Use It

• Reduces legal penalties, operational disruptions, reputational damage.
• Drives efficiency (10-20% cost savings), better decision-making, integrity culture.
• Meets regulator expectations, enhances market access, prepares for ISO 37301 certification.
• Builds stakeholder trust across industries.

Implementation Overview

• **Phased roadmapleadership commitment, gap analysis, design/documentation, rollout, continuous improvement via PDCA.
• Scalable for SMEs/startups to multinationals; all geographies/sectors.
• No formal certification; internal audits and self-assessments suffice.