Regulatory & Compliance
GxP Audit Consulting.
We conduct GMP, GLP, and GCP audits for the pharmaceutical, biotech, and medtech industries—both internally and at suppliers’ sites—as well as in preparation for regulatory inspections.
What GxP challenges do companies face in practice?
GxP requirements (GMP, GLP, GCP, GDP, GVP) are complex and apply across industries. Audits often present challenges:
- Suppliers and CDMOs are not adequately audited for GxP compliance, or such audits are conducted too infrequently.
- Internal GxP audits are often missing or are not designed correctly, resulting in blind spots.
- GxP-critical findings from past inspections have not been fully resolved.
- GxP requirements are constantly evolving; internal auditors are not always up to date with the latest regulatory requirements.
When was the last time you conducted a comprehensive, systematic GxP audit of your most critical suppliers?
Our GxP audit services.
We cover the full range of GxP services—from internal process audits to complex supplier qualifications.
GMP Audits for Manufacturers & CDMOs
Assessment of the GMP status of manufacturing sites, contract manufacturers, and API producers. Review of QMS, batch records, validations, and CAPA systems against the EU GMP guidelines and FDA requirements.
GLP Audits for Laboratories & CROs
Audits of testing laboratories and CROs in accordance with OECD GLP principles. Review of study archives, equipment qualification, and protocols to prepare for regulatory authorities.
GCP Audits for Clinical Trials
Audit of clinical trial sites, CROs, and sponsor systems in accordance with ICH E6 GCP. Review of informed consent forms, randomization processes, monitoring reports, and Trial Master Files (TMF).
Supplier Audits & Qualification
Structured third-party audits for your critical GxP suppliers. We handle the development of audit plans, on-site execution, and the preparation of comprehensive assessment reports.
Frequently Asked Questions About GxP Audits.
What exactly does the term GxP mean?
GxP is an umbrella term for all regulatory "good practice" guidelines in the life sciences: GMP (manufacturing), GLP (laboratories), GCP (clinical trials), GDP (distribution), and GVP (pharmacovigilance).
Who is authorized to conduct official GxP audits?
GxP audits are conducted either internally (by the Quality Department), by qualified external consultants (such as ENTOURAGE), or by regulatory authorities or Notified Bodies. Supplier audits are typically conducted by the contracting manufacturer.
How often must GxP supplier audits be conducted?
This depends on the supplier’s criticality. Typically, critical suppliers (e.g., for APIs or sterile packaging) are audited every 1 to 3 years. New contract manufacturers must be audited prior to their first assignment.
What is the difference between a GxP audit and an inspection?
A GxP audit is a voluntary or contractual inspection (conducted internally or at suppliers’ sites). An inspection is an official review conducted by the relevant national or international regulatory authority (e.g., EMA, FDA) with direct legal consequences.
Additional expertise in the area of audit and compliance.
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