GMP Certification in Singapore:

GMP Certification in Singapore, Vertex Certifiers is a trusted global GMP consulting and certification partner, delivering end-to-end GMP implementation support across Singapore, Jurong, Tuas, Woodlands, Tampines, Changi, and One-North. We support organizations in the pharmaceutical, biotechnology, food, medical device, and cosmetics sectors—from GMP gap analysis and facility readiness assessment to SOP development, staff training, internal audits, and inspection support aligned with HSA, PIC/S, WHO, and SFA requirements. Backed by experienced GMP auditors and a strong global presence, Vertex enables Singapore-based companies to achieve audit-ready, compliant, and internationally recognized GMP systems efficiently.

What Is GMP and Its Regulatory Framework in Singapore

Good Manufacturing Practices encompasses principles and practices preventing contamination, mix-ups, and errors during production, ensuring product quality from raw materials to final packaging. In Singapore, HSA enforces GMP for pharmaceuticals, medical devices, and biologics under the Health Products Act, harmonized with WHO GMP and PIC/S standards for international reciprocity. SFA mandates GMP for food processing under the Food Regulations, while cosmetics align with ISO 22716 where applicable, supporting ASEAN harmonization. This framework positions Singapore firms for seamless exports to EU, US FDA, and ASEAN markets.

Who Needs GMP Certification in Singapore

Pharmaceutical manufacturers and importers require GMP to license operations and export APIs or finished drugs.[prior industries]

• Biotechnology and Active Pharmaceutical Ingredient (API) producers comply for clinical trial materials and commercial supply.
• Medical device manufacturers follow HSA’s GMP Annex 1 for sterile and non-sterile products.
• Food and beverage processors secure SFA approvals for HACCP-integrated GMP.
• Nutraceutical, supplement, and cosmetics firms meet voluntary yet market-essential standards.
• Contract manufacturers and packaging units demonstrate compliance for client audits.

Process to get GMP Certification in Singapore:

Initiate with a GMP gap assessment against HSA/WHO guidelines, evaluating facilities, processes, and documentation.

Conduct facility readiness reviews, develop SOPs, validation protocols, and records, followed by staff training on hygiene and compliance.

Perform internal audits and mock inspections to simulate HSA scrutiny, then apply for official inspection leading to GMP approval.

Core GMP Requirements in Singapore

A robust Quality Management System (QMS) with GMP policy sets oversight, including organizational charts and responsibilities.[prior requirements]

Personnel must maintain hygiene, undergo GMP training, and demonstrate competency; facilities feature controlled environments, cleanrooms, and utilities validation.

Equipment requires qualification (IQ/OQ/PQ), calibration, and maintenance; materials demand controlled receipt, storage, traceability, and batch records.

Deviation handling, CAPA, and change control ensure continual improvement per PIC/S pharma GMP.