Trillyum Consulting

GMP auditing services

Independent GxP audits of facilities, quality systems, suppliers and subcontractors, conducted by experienced senior GMP auditors.

GMP audits and inspections are pivotal in the development and manufacture of medicines, and regulators expect GMP compliance across the entire supply chain.

Engaging with an increasingly complex network of suppliers, service providers and subcontractors is therefore an obligation, and an experienced GMP auditor who can evaluate and monitor your quality management system and supply chain provides insight that improves your control over quality.

Our team of senior GMP auditors has extensive experience conducting pharmaceutical audits aligned with GMP. We specialise in regulatory GxP audits against the applicable texts and standards, including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Our internal procedures, quality system and auditor-qualification process are themselves regularly audited by our clients.

What our audits cover

Expert GMP auditors

Seasoned auditors with a deep understanding of pharmaceutical operations and a keen eye for areas of improvement.

Regulatory compliance

Auditors stay current with the latest regulations and guidelines so your organisation meets all applicable requirements.

Supply-chain focus

Evaluation and monitoring of suppliers and subcontractors to identify risk and non-compliance across a complex global supply chain.

Comprehensive scope

Production processes, quality control, documentation practices and supplier management: a complete evaluation of GMP adherence.

Tailored approach

Audit scope and recommendations aligned with your organisation’s goals and specific requirements.

Continuous improvement

Actionable recommendations that strengthen quality systems, streamline processes and improve efficiency, not only a list of non-compliances.

Standards we audit against

Regulatory GxP audits

Audits adhere to the applicable regulatory texts and standards.

01

GMP

Good Manufacturing Practice for production, quality control and the quality system.

02

GDP

Good Distribution Practice across wholesalers, logistics providers and the supply chain.

03

GLP

Good Laboratory Practice for non-clinical and quality-control laboratories.

04

GCP

Good Clinical Practice for clinical trial conduct and oversight.

05

GVP

Good Pharmacovigilance Practice for safety monitoring and reporting.

06

Supplier and subcontractor audits

Qualification and monitoring of suppliers, service providers and subcontractors.

How an audit runs

A clear process from scoping to close-out

  1. Step 1

    Scope

    Agree the standard, site or supplier, and the areas to cover.

  2. Step 2

    Plan

    Audit plan and agenda shared in advance so the right people and records are available.

  3. Step 3

    Audit

    On-site or remote review of facilities, systems, documentation and interviews.

  4. Step 4

    Report

    Written report with observations graded by risk and a practical recommendation for each.

  5. Step 5

    Close out

    Close-out meeting, CAPA guidance and follow-up verification where required.

Audit questions

Q1What types of audits can a pharmaceutical audit consulting firm perform?

GMP audits, supplier audits, internal audits, mock audits, regulatory-compliance audits and quality-management-system audits, among others. The scope is tailored to your organisation’s needs and regulatory requirements.

Q2How often should a pharmaceutical audit be conducted?

Frequency depends on regulatory requirements, the complexity of operations, risk level and quality-management practices. Many companies audit annually; others more frequently or on specific triggers such as process changes or regulatory updates.

Q3Can an audit consulting firm assist with regulatory inspections?

Yes. Preparation can include mock inspections, identification of potential non-compliance, corrective action plans and support during the inspection itself, as well as strategies to maintain compliance afterwards.

Q4What are the benefits of regular pharmaceutical audits?

Improved regulatory compliance, enhanced product quality, reduced risk of non-compliance and recalls, identification of process inefficiencies, better documentation and record management, and greater overall operational excellence.

Plan an audit of your site or your suppliers.

Request a consultation

Related services

Auditing

Facility and system audits

Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.

Learn more

Auditing

Due diligence

Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.

Learn more