SpecGx LLC
- GMP_EXCIPIENTS, GMP_API
- St. Louis, USA
- PLANNED
- Qualifyze
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Human-centric approach
Feel supported by our team of audit experts with decades of combined experience. Let people you trust take the entire audit burden off your plate.
Centralized audit management
Centralize all audit-related communications including CAPA follow ups, document signings, invoicing and more. All in one secure, digital platform.
Audit reports, made simple
Expertly designed to deliver you information in a crisp, clear format. Impeccable english and traffic light CAPA follow up system for an easy, actionable review process.
Think global, act local
We can facilitate better communication with auditees, more flexible audits and less C02 emissions thanks to our large network of international, multi-lingual auditors.
FAQs
What is a GMP audit?
A GMP audit is an evaluation of a pharmaceutical manufacturer or supplier to verify compliance with Good Manufacturing Practice (GMP) regulations. These audits review quality management systems, documentation procedures, manufacturing controls, and data integrity processes. Pharmaceutical companies conduct GMP audits to ensure that suppliers consistently produce safe and compliant products that meet regulatory requirements.
Why do pharmaceutical companies audit suppliers?
Pharmaceutical companies audit suppliers to verify that external manufacturers, laboratories, and service providers comply with regulatory and quality standards. Supplier audits help identify potential compliance risks, confirm GMP adherence, and ensure that materials and services used in drug production meet strict quality requirements. These audits are a critical part of supplier qualification and ongoing risk management.
What is included in a pharmaceutical audit report?
A pharmaceutical audit report typically includes the audit scope, observations, compliance findings, and recommendations for improvement. It may also document the supplier’s quality management system, laboratory controls, manufacturing processes, and corrective and preventive actions (CAPA). Audit reports help pharmaceutical companies assess supplier reliability and regulatory compliance.
How often are pharmaceutical suppliers audited?
The frequency of supplier audits depends on risk level, regulatory requirements, and supplier criticality. High-risk or critical suppliers may be audited every one to two years, while lower-risk suppliers may be audited less frequently. Risk-based audit programs help pharmaceutical companies prioritize resources and focus on suppliers that have the greatest impact on product quality.
What is the difference between a GMP audit and a supplier audit?
A supplier audit evaluates a third-party organization that provides materials, manufacturing services, or testing services. A GMP audit specifically focuses on verifying compliance with Good Manufacturing Practice regulations. In the pharmaceutical industry, supplier audits are often conducted under GMP standards to ensure that external partners meet regulatory quality requirements.
Why are third-party audit reports useful?
Third-party audit reports allow pharmaceutical companies to access independent assessments of supplier compliance without conducting a full audit themselves. These reports can significantly reduce supplier qualification time and eliminate duplicate audits across the industry. Shared audit models help companies maintain compliance while optimizing resources.