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, are all scrutinised. 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, 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.
Trusted by top-tier teams worldwide
Our Good Manufacturing & Distribution Practice auditing services include:
- API and Investigational Medicinal Product (IMP) audits
- Contract Manufacturing Organisations (CMO / CDMO)
- Storage and distribution centres
- Test laboratories
- Records
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.
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
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…
GMP Audits
GMP Audits Introduction UK Based Biotech The company is a worldwide large biotech with a vast portfolio of biotech products (mainly oncology). Apotech auditors: 3 auditors are involved in this partnership. Types of Audits Contracts/agreements between the clients and the provider GMP/GDP Client SOPs Local regulations Audit Locations Europe The audited sites are: Client manufacturing…