What It Is

Good Manufacturing Practices (GMP/cGMP) is a regulatory framework enforcing minimum standards for manufacturing controls in pharmaceuticals, biologics, and related products. Its primary purpose is ensuring consistent production meeting quality, safety, and efficacy criteria through preventive systems rather than end-testing alone. Scope spans facilities, equipment, personnel, processes, documentation, and distribution. Key approach is risk-based via Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Key Components

• **5 Ps pillarsPeople, Premises, Processes, Procedures, Products.
• Core elements: independent Quality Control Unit, validated processes, ALCOA++ data integrity, CAPA, change control.
• Built on ICH Q9/Q10, FDA 21 CFR 210/211, EU EudraLex Vol. 4, WHO GMP.
• Compliance via inspections, no central certification but enforcement actions.

Why Organizations Use It

Mandated for market access; reduces recalls, liability. Strategic benefits: supply reliability, efficiency, innovation enablement. Builds regulator, patient trust; prevents historical tragedies like Elixir Sulfanilamide.

Implementation Overview

Phased: gap analysis, Validation Master Plan, training, qualification (IQ/OQ/PQ), audits. Applies to all sizes in pharma/biologics globally; ongoing inspections required.

What It Is

BRCGS Global Standard for Food Safety (Issue 9) is a GFSI-benchmarked certification framework for food manufacturers, processors, and packers. It ensures product safety, legality, authenticity, and quality through a structured management system combining senior management commitment, Codex HACCP-based food safety plans, and robust prerequisite programs (GMP/GHP).

Key Components

• Nine core clauses: senior management, HACCP, FSQMS, site standards, product/process controls, personnel, risk zones, traded products.
• Fundamental requirements (e.g., traceability, allergen management, internal audits) are non-negotiable.
• Built on risk assessments, environmental monitoring, and root cause analysis.
• Annual audits with grading (AA/A/B/C/D, + for unannounced).

Why Organizations Use It

• Mandated by retailers for market access and supply chain trust.
• Reduces recalls via controls on allergens, pathogens, labelling.
• Demonstrates due diligence, GFSI recognition, operational resilience.
• Enhances reputation, efficiencies, insurance terms.

Implementation Overview

• Phased: gap analysis, documentation, training, mock audits.
• Applies to manufacturers globally; 6-12 months typical.
• Requires certification body audits, continuous improvement.