What It Is

Good Manufacturing Practices (GMP/cGMP) are legally enforceable regulatory frameworks, such as FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP, establishing minimum standards for manufacturing controls. Their primary purpose is preventing contamination, mix-ups, and variability in pharmaceuticals, biologics, and related products through preventive, risk-based systems rather than end-product testing alone.

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
• Elements include Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), validated processes/equipment, independent quality oversight, documentation, training, and audits
• Built on ICH Q9/Q10 principles; no fixed control count but comprehensive subparts/chapters
• Compliance via inspections, no central certification but site approvals

Why Organizations Use It

Mandated for market access; reduces recalls, liabilities, and enforcement actions. Enhances supply reliability, operational efficiency, and reputation. Strategic for global trade via harmonization (PIC/S, MRAs).

Implementation Overview

Phased approach: gap analysis, Validation Master Plan, system design, qualification (IQ/OQ/PQ), training, audits. Applies to pharma/biologics manufacturers globally; requires ongoing inspections and continual improvement.

What It Is

APRA Prudential Standard CPS 234 (Information Security) is a binding prudential regulation issued by the Australian Prudential Regulation Authority, effective 1 July 2019. It mandates APRA-regulated entities—such as banks, insurers, and superannuation funds—to maintain an information security capability commensurate with threats and vulnerabilities to their information assets. The approach is risk-based, emphasizing proportionality to asset criticality, sensitivity, and potential impacts.

Key Components

• **GovernanceBoard ultimate responsibility, defined roles, policy framework.
• **Risk ManagementAsset identification, classification by criticality/sensitivity, commensurate controls across lifecycle.
• **OperationsIncident detection/response plans (annually tested), third-party assessments.
• **AssuranceSystematic testing, independent internal audit, notifications (72 hours for material incidents, 10 business days for weaknesses). No fixed control count; built on CIA triad (confidentiality, integrity, availability).

Why Organizations Use It

• Mandatory for APRA-regulated entities to avoid enforcement, penalties, remediation.
• Enhances operational resilience, reduces incident impacts, builds customer trust.
• Strategic benefits: competitive differentiation, better vendor terms, cost avoidance.

Implementation Overview

Phased approach: gap analysis, governance/policy, asset register/controls, testing/assurance, continuous monitoring. Applies to all sizes of APRA entities in Australia; requires evidence for APRA supervision, no formal certification.