A GMP audit is the examination of a manufacturer for compliance with Good Manufacturing Practice. Pharmaceutical companies carry it out at every contract filler before entrusting sterile products to them, and repeat it at fixed intervals. The audit decides whether the site is added to the approved supplier list. This article shows how a GMP audit works, which documents are reviewed and which findings occur most often.
Key takeaways
- A GMP audit at a contract filler usually takes one to two days and follows an agenda agreed in advance.
- It covers the quality system, personnel, premises and equipment, documentation, production, quality control and outsourced activities.
- Lubeca fill provides auditors with the site master file, hygiene concept and qualification documents beforehand.
What is a GMP audit?
GMP stands for Good Manufacturing Practice. In the EU it is laid down in the EU GMP guide, and for sterile medicines additionally in Annex 1. A GMP audit differs from a regulatory inspection. The authority checks whether a site obtains or keeps its manufacturing authorisation. The customer, on the other hand, checks whether the site is suitable for its specific product. Both are part of supplier qualification, which chapter 7 of the EU GMP guide requires for outsourced activities.
How does a GMP audit at a contract filler work?
First the client sends a questionnaire, which the filler answers with documents. Then comes the on-site visit with an opening meeting, a walk-through and a document review. The auditor follows the material flow, from goods receipt through the cleanrooms to dispatch. At the end, the auditor names deviations, classified as critical, major and minor. The filler then receives a report and submits an action plan.
Checklist: areas covered by a GMP audit
| Area | Typical checkpoints |
|---|---|
| Quality system | Quality manual, deviations, CAPA, change control, self-inspections |
| Personnel | Organisation chart, training records, hygiene training, deputies |
| Premises and equipment | Cleanroom grades, pressure cascade, qualification IQ OQ PQ, maintenance, calibration |
| Documentation | Manufacturing instructions, batch records, data integrity, archiving |
| Production | Line clearance, process parameters, media fill, environmental monitoring |
| Quality control | Test methods, sampling, retained samples, stability programme |
| Outsourced activities | Supplier evaluation, contracts with laboratories and packaging suppliers |
| Complaints and recalls | Procedures, deadlines, mock recall |
Which documents should the filler provide in advance?
- Site master file describing site, equipment and products
- Manufacturing authorisation or status of the licensing procedure
- Organisation chart and responsibilities
- List of standard operating procedures
- Qualification reports for cleanrooms and equipment
- Results of the latest media fills and environmental monitoring
- Reports of previous audits and inspections
The most common findings in audit reports
Auditors most often object to incomplete documentation, for example missing signatures or changes that cannot be traced. Next come weaknesses in deviation management, such as deviations without root cause analysis. Overdue calibrations and training records are also frequent. Critical findings, on the other hand, usually concern sterility assurance, meaning media fills, environmental monitoring or behaviour in the cleanroom.
How Lubeca fill prepares for your GMP audit
Lubeca fill was founded in 2019 and operates a plant in Çorlu near Istanbul with equipment from Groninger, Bausch + Ströbel and Syntegon. EU GMP certification is currently in preparation, and customer audits are part of this path. We provide you with the site master file, hygiene concept and qualification documents in advance and accompany you on site through production and cleanrooms. Istanbul can be reached from Germany in around three flight hours, so an audit is possible in one day. Read more about the requirements in the article on contract filling according to EU GMP and about site selection in the article on nearshoring.
Frequently asked questions about GMP audits
How often is a contract filler audited?
An initial audit before approval is standard, followed by a re-audit every two to three years, or annually for critical products.
Does a GMP certificate replace the customer audit?
No. The certificate documents the regulatory inspection. The customer audit checks suitability for the specific product and is the client’s duty under chapter 7 of the EU GMP guide.
Can a GMP audit be carried out remotely?
A remote audit is possible for re-audits. For the initial qualification of a sterile site, most clients prefer an on-site visit.
Would you like to audit Lubeca fill? Arrange an appointment and we will send you the documents in advance.
