As advanced therapeutics and biological products continue to reshape the future of healthcare, organisations developing innovative therapies are facing increasing regulatory expectations around manufacturing quality, sterility assurance, validation, and data integrity.
SeerPharma was recently engaged by a Singapore-based Contract Research, Development and Manufacturing Organisation (CRDMO) to conduct a mock GMP audit in preparation for voluntary certification by the Singapore Health Sciences Authority (HSA).
The client is a vertically integrated CRDMO founded in Singapore with a strong scientific foundation and a growing focus on clinical manufacturing capabilities, the organisation is preparing for future expansion into later-stage clinical manufacturing activities.
Preparing for HSA GMP Certification
The engagement forms part of the client’s strategic initiative to achieve voluntary GMP certification for the manufacture of clinical trial material, specifically for products classified as Biological Medicinal Substances and Products.
As biological and sterile medicinal products continue to attract heightened regulatory scrutiny globally, organisations manufacturing investigational products are expected to demonstrate robust compliance with international GMP requirements, particularly those relating to contamination control, aseptic processing, validation, and computerised systems.
To support this objective, SeerPharma was requested to perform a comprehensive mock GMP audit of the client’s Singapore manufacturing operations. The assessment focused on the manufacture of Phase I clinical trial material, while also considering the organisation’s future plans to expand into Phase II manufacturing.
Assessment Scope Aligned with PIC/S and HSA Expectations
The mock audit was designed to assess the organisation’s readiness against key Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP requirements adopted by HSA.
The scope of the assessment included:
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PIC/S Guide to GMP for Medicinal Products PE009-17 Part I
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Annex 1 – Manufacture of Sterile Medicinal Products
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Annex 2B – Manufacture of Biological Medicinal Substances and Products for Human Use
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Annex 11 – Computerised Systems
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Annex 13 – Manufacture of Investigational Medicinal Products
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Annex 15 – Qualification and Validation
Given the complexity of biological manufacturing and sterile processing operations, the assessment focused not only on procedural compliance, but also on practical implementation, facility controls, validation strategies, contamination control measures, and data integrity practices.
Hybrid Audit Approach
To maximise efficiency while enabling a detailed review of systems and operations, the assessment was conducted using a hybrid audit model combining both remote and onsite activities.
This approach included:
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Remote review of core Pharmaceutical Quality System (PQS) documentation
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Assessment of computerised systems and electronic records
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Onsite inspection of facilities, manufacturing operations, utilities, and process flows
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Review of qualification and validation documentation
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Evaluation of contamination control and sterile manufacturing practices
SeerPharma utilised its structured GMP audit checklists and risk-based assessment methodologies to identify strengths, potential compliance gaps, and areas requiring remediation prior to formal regulatory engagement.
Supporting Clinical Manufacturing Readiness
For emerging biologics manufacturers, preparing for GMP certification involves far more than documenting procedures. Regulators increasingly expect organisations to demonstrate mature quality systems, effective contamination control strategies, validated systems and processes, and a strong culture of quality oversight.
Particular attention is often placed on:
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Sterility assurance and contamination control
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Environmental monitoring programs
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Qualification and validation lifecycle management
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Data integrity controls
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Computerised system governance
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Investigational medicinal product management
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Personnel training and aseptic behaviours
Mock audits play a critical role in helping organisations evaluate their operational readiness before formal regulatory inspections, enabling issues to be identified and addressed proactively.
Supporting the Growth of Advanced Therapeutics Manufacturing
As the biologics and advanced therapeutics sector continues to evolve across the Asia-Pacific region, organisations developing innovative products must navigate increasingly complex GMP and regulatory expectations.
SeerPharma continues to support pharmaceutical, biotechnology, and advanced therapy organisations through GMP auditing, quality system development, contamination control strategy support, validation, computerised systems compliance, and regulatory readiness programs across the broader APAC region.
For organisations preparing for regulatory inspections, GMP certification, or clinical manufacturing expansion, mock GMP audits can provide valuable insight into operational readiness and help reduce compliance risks before formal agency engagement.
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