GxP Audit Services
As one of the life sciences industry's leading Quality and Audit Consulting firms, Apotech uses a modern and flexible approach to meet all of our client’s global audit requirements.
Embrace a modern approach to auditing
Global complexity, simplified locally
From managing your full auditing program to delivering a single audit on an ad hoc request, we provide tailor-made audit offerings across a wide range of areas within the life sciences industry.
These include Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Computer System Validation (CSV) auditing services – all of which are designed to ensure complete compliance.
Trusted by top-tier teams worldwide
Good Clinical Practice (GCP)
We maintain a thorough awareness of the latest GCP requirements to ensure compliance. Our team possesses the necessary expertise to assess whether other organisations adhere to GCP standards.
GCP audits are an essential component of the quality assurance system in clinical trials for both medicinal products and medical devices. But, if your resources are limited, we can help.
With audits able to be conducted either remotely or on-site, our team at Apotech boasts a qualified team of GCP auditors that can independently assess any CROs pre-selected to conduct clinical trials or evaluate ongoing trials.
Our GCP auditing services cover a range of areas, including:
- Investigator sites
- Clinical Research Organisation (CRO)
- Vendors
- Mock Inspections
- Documentation
- TMF
- Systems and internal processes
- Data Management
- Statistics and programming
Good Laboratory Practice (GLP / GCLP)
Maintaining good laboratory practice is essential for laboratories and research facilities in the life sciences sector, as they not only ensure compliance with regulatory requirements but also enhance the credibility and reliability of the data generated.
Unlock the full potential of your laboratory operations with our specialised GLP auditing services.
Designed to meet the unique demands of the life science sector, we can provide:
- Study audits
- Facility inspections
- Critical phase/processes
- Data audits
- Archive audits
- Document reviews
- Study report and raw data
- Animal laboratories
Good Pharmacovigilance Practice (GVP / GPVP)
Pharmacovigilance regulations mandate Marketing Authorization Holders (MAHs) to conduct audits of their pharmacovigilance systems, incorporating risk-based assessments of their quality frameworks.
As outlined in GVP Module I, a GVP audit is a structured, rigorous, independent and documented process aimed at gathering and objectively evaluating evidence to determine the fulfilment of audit criteria. This process contributes to enhancing risk management, control and governance procedures.
Pharmacovigilance audit tasks involve scrutinising the implementation and operation of a pharmacovigilance system, including its quality framework for pharmacovigilance activities, by assessing objective evidence.
If you’re looking to outsource your GVP audits, we are a trusted partner with a track record of conducting audits for numerous domestic and international clients.
Our GVP auditing services include:
- PV system audits
- Partners and distributors
- Medical Information
- Call centres
- Market Research Programs (MRP)
- Patient Support Programs (PSP)
- Compassionate Use Programs (CUP)
- Speciality pharmacy
- Risk Evaluation Mitigation Strategies (REMS)
- QPPV and LSO
- Affiliates and local operating companies
- Internal process
- Patient support programs
- Post-authorisation Safety Studies (PASS)
Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP)
Manufacturers of drug substances and drug products are obligated to adhere to Good Manufacturing Practice (GMP) regulations via a GMP audit. These audits investigate quality control and warehouse facilities to assess whether manufacturing sites adhere to an extensive array of GMP rules, as outlined in the Pharmaceutical Quality System.
Various aspects, such as manufacturing processes, quality control procedures, personnel practices, raw material oversight, outsourced activities, self-inspection, handling of deviations, complaints and product recall, for example, are all scrutinised, while separate GMP guidelines can also be applied for Active Pharmaceutical Ingredients (APIs) or medicinal products used in clinical trials.
For medicinal product manufacturing sites, GMP compliance is confirmed through a Manufacturing and Import Authorisation (MIA) and/or a GMP certificate from a Competent Authority. Active substance manufacturers, on the other hand, including intermediates, depend on a QP declaration by the Qualified Person (QP) to affirm GMP adherence.
Our team at Apotech can provide both of these options: a manufacturing site audit by our QP or an evaluation of external audit documents.
Having successfully conducted numerous audits, we have helped numerous companies implement GMP principles in their manufacturing sites and achieve favourable outcomes in inspections by regulatory agencies.
Our GMP auditing services cover a range of areas, including:
- API and IMP audits
- Contract Manufacturing Organisations (CMO / CDMO)
- Storage and distribution centres
- Test laboratories
- Records
Computer System Validation (CSV)
Our Computer System Validation (CSV) Audit Services at Apotech Consulting are tailored to ensure that computerised systems are compliant with relevant regulatory standards and industry best practices.
Through our range of services, our team can meticulously assess the accuracy, consistency and repeatability of systems, ensuring they perform as intended in a controlled and predictable manner. This involves comprehensively evaluating system life cycle documentation, validation plans, testing protocols and data integrity measures.
Our CSV auditing services include:
- Software suppliers
- Electronic records and signatures
- Infrastructure & IT service providers
- Statistics and programming
- GxP-related systems
- Internal Process
Excited to work together on your next project?
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
Audits conducted in 2023
A network of Auditors / GxP areas
Coverage of countries
Why choose Apotech’s auditing services?
At Apotech, our onsite or remote audits help pharmaceutical, biotechnology and medical device companies maintain the highest standards of quality and safety. Thanks to our in-house auditing experience, we provide tailor-made solutions that you can trust.
We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
We’re experienced
Our auditors have a minimum of 20 years of experience and have individually led over 100 audits for various companies across the life sciences sector.
We provide competitive pricing
Our pricing model is competitive and keeps the costs required for expenses and travel purposes at a minimum.
We speak your language
Wherever you are in the world, our auditors can perform audits in a wide variety of countries and communicate with you in your local language.
The benefits of an onsite audit
Onsite audits are pivotal for GxP pharmaceutical practices.
Not only do they ensure regulatory compliance but they also play a key role in verifying documentation accuracy, conducting risk assessments and inspecting facilities to maintain optimal conditions.
By evaluating personnel competency and assessing supplier performance in this way, onsite audits contribute to the continuous improvement of processes and systems, helping ensure only the most reliable information is submitted to regulatory authorities.
FAQs on Audits
We provide a modern approach to auditing that offers full transparency. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, our team can provide comprehensive CAPA (Corrective and Preventive Action) Management support.
Our modern and flexible approach ensures effective handling of CAPA processes, helping not only address and prevent any non-conformities but also contribute towards the continual improvement of both quality and compliance.
Featured case studies
GCP Audits – Europe
Seagen is a global biotechnology company dedicated to revolutionizing cancer care. They are Headquartered in the US & Switzerland with a large footprint in the EU.
Outsourced internal GMP & GVP Audits
Outsourced internal GMP & GVP Audits Introduction Multinational biotech The French affiliate of a multinational Biotech company has its own QMS. Upon the QP responsibility, they conduct their internal audit with a 3-year plan (at the end of a 3 year cycle, they have audited all of their processes). Apotech consultants 2 External auditors Both…
GVP Audits Worldwide
GVP Audits Worldwide Introduction US Biotechnology Our client is a global Biotechnology company dedicated to genetics and molecular biology. They are Headquartered in the US, with offices in most major economies. Apotech auditors Our Auditors have 20+ years’ experience in the industry and have all conducted over 100 GVP audits. Types of Audits Affiliate Distributor/…