Brand Inspection

Good Manufacturing Practice (GMP constitutes a critical component of quality assurance, ensuring pharmaceutical products are consistently manufactured and controlled to meet quality standards aligned with their intended use and marketing authorizations. It guarantees that products are safe, effective, and compliant with regulatory requirements, thereby safeguarding public health.

CAPA Consult operates under a framework analogous to regulatory authorities, empowered to oversee and regulate the manufacture, importation, exportation, distribution, advertisement, sale, and use of pharmaceutical products. This mandate emphasizes ensuring product quality, safety, and efficacy through the implementation of CAPA Consult Good Manufacturing Practice Regulations, which establish minimum standards for manufacturing processes, facilities, and controls.

Key aspects of the guidelines include:

Scope: Applies to pharmaceutical, biological, and veterinary products under marketing authorizations, including manufacturing processes in hospitals.

Exclusions: Does not cover pharmacist-led compounding in health institutions for individual prescriptions.

Responsibility: Requires top management leadership and organization-wide commitment, extending to suppliers and all operational levels.

Implementation Framework: Regulatory Alignment: Guidelines ensure products meet safety, quality, and efficacy claims through validated methods, controlled facilities, and rigorous documentation.

Operational Requirements: Covers manufacturing, processing, packaging, and storage, with emphasis on risk mitigation and adherence to standardized procedures.

Stakeholder Compliance: Provides actionable standards for manufacturers and distributors to maintain consistency and traceability across product lifecycles.

By integrating these principles, CAPA Consult reinforces a culture of quality, ensuring products remain fit for purpose while minimizing risks to end-users.

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