Audit & Assurance
Good Manufacturing Practice Audits
Independent, risk-based GMP audits for pharmaceutical and biotechnology manufacturers, contract manufacturers and API suppliers, aligned to EU GMP, FDA 21 CFR 210/211 and ICH Q10.
Executive Overview
Good Manufacturing Practice audits form the foundation of any pharmaceutical quality assurance programme. Regulatory authorities, including the EMA, MHRA and FDA, expect organisations to maintain robust supplier qualification systems, demonstrate control of manufacturing operations and provide evidence that quality systems function as designed. Independent audit provides the objective evidence that internal review alone cannot reliably deliver.
Sthira Assure conducts GMP audits against current regulatory expectations, not generic checklists. Our approach draws on direct experience of regulatory inspection practices, industry trends in audit observations and the specific requirements of EU GMP Parts I and II, FDA 21 CFR 210/211 and relevant ICH Q-series guidelines. Every audit is scoped to reflect the risk profile of the site, the nature of the operations and your organisation's specific compliance objectives.
We work with pharmaceutical manufacturers, biotechnology companies, CDMOs, API suppliers and packaging material manufacturers. Whether you are conducting a single supplier qualification audit or managing a global annual audit programme, our structured methodology ensures consistent, defensible and regulatory-quality findings.
Regulatory Frameworks
- EU GMP Parts I & II
- FDA 21 CFR 210/211
- ICH Q7 (API)
- ICH Q10 (QMS)
- ICH Q9 (Risk Management)
- WHO GMP
- PIC/S GMP
Why GMP Audits Matter
Pharmaceutical manufacturers are legally obligated to ensure that medicinal products are consistently manufactured and controlled to quality standards appropriate for their intended use. GMP audits, of internal operations, contract manufacturers and material suppliers, are the mechanism through which organisations discharge this obligation.
Regulators view the quality of an organisation's supplier qualification and audit programme as a direct indicator of its overall quality culture. Organisations that cannot demonstrate a systematic, risk-based approach to GMP oversight regularly face warning letters, import alerts and suspension of manufacturing operations.
Beyond regulatory compliance, effective GMP audits identify systemic quality risks before they materialise as product failures, batch rejections or supply disruptions. The cost of prevention is invariably lower than the cost of remediation following an inspection observation or market recall.
Independent audit also provides the objectivity that internal quality teams cannot reliably provide. Audit teams embedded within an organisation develop familiarity with existing practices that can compromise critical assessment. External auditors bring fresh perspective, benchmarking against current regulatory practice and experience of findings from comparable organisations and sites.
For organisations using contract manufacturers and API suppliers, GMP audit is specifically required under EU GMP Chapter 7 (Outsourced Activities) and FDA CGMPs. Quality agreements must be backed by audit evidence, not just contractual commitments. Regulators expect that you have independently verified the GMP compliance status of the suppliers to whom you transfer manufacturing responsibility.
Common Compliance Risks
Inadequate Supplier Oversight
Many organisations approve suppliers based on questionnaire responses or historical relationships rather than evidence-based assessments. This leaves quality agreement gaps, undisclosed process changes and unverified CAPA effectiveness, each a common FDA warning letter trigger.
Data Integrity Vulnerabilities
Laboratory and manufacturing data integrity remains the single most cited area in FDA warning letters and EMA inspection findings. Poor audit trail design, shared login credentials and manual data transcription create systemic risk that standard QA oversight often misses.
Change Control Failures
Undocumented or inadequately assessed changes to manufacturing processes, equipment and computer systems are a persistent source of regulatory observations. Inspectors routinely find that change impact assessments lack sufficient rigor and that validation activities are poorly documented.
CAPA Ineffectiveness
Corrective and preventive action systems that address symptoms rather than root causes result in recurring deviations and inspection findings. Regulators expect evidence of systematic root cause analysis, defined timelines and effectiveness checks, not just closure entries in a tracking system.
Scope of Services
Our GMP audit services cover the full range of sites and systems within pharmaceutical and biotechnology supply chains and manufacturing operations.
Common Audit Findings
The following represent frequently observed findings during GMP audits of pharmaceutical manufacturers and their supply chains. These are not edge cases, they represent systemic gaps that independent audit routinely identifies.
Frequently Asked Questions
How long does a typical GMP audit take?
Supplier and third-party GMP audits typically take one to two days depending on site complexity, scope and the range of operations assessed. Internal audits across multiple departments may span two to three days. We provide a tailored scope document before each engagement.
Can audits be conducted remotely?
Remote and hybrid audit formats are available for document-intensive assessments including change control, CAPA and quality system reviews. Onsite presence is recommended for sterile manufacturing, laboratory operations and situations where physical facility walkthrough is essential to the audit objective.
What does the audit report contain?
Reports include an executive summary, audit scope and methodology, individual findings with risk classification (critical, major, minor), regulatory references for each finding, and recommended corrective actions. Reports are issued within 10 working days of audit completion.
Do you verify CAPA responses?
We offer CAPA response review and effectiveness verification as a follow-on service. This confirms that actions taken adequately address the root causes identified and that the corrective measures have been implemented as described.
Request a GMP Audit
Contact our team to discuss your audit scope, site type and timeline. We will provide a tailored proposal within two business days.