Good Manufacturing Practice (GMP) audit
Good Manufacturing Practice (GMP) is the most fundamental set of compliance standards for pharmaceutical, dietary supplements and cosmetics industries to ensure that manufacturers are producing safe and quality products. GMPs are critical to protect consumers, especially for medicinal products and raw materials such as active pharmaceutical ingredients (APIs) and excipients.
Scope of Good Manufacturing Practice
GMP is commonly adopted by multiple markets including EU, USA, Brazil, Canada, Mexico, India, China, Japan, Korea and Taiwan as a regulatory requirement for pharmaceutical industry to evaluate the quality and safety of a pharmaceutical manufacturing facility, both for sterile and non-sterile products.
For the dietary supplement and cosmetic industries, while there are some exceptions, GMP compliance, is broadly required, with new GMP regulations and rising retailer standards raising the bar each year. To ensure continued compliance, manufacturers must be prepared to proactively monitor and improve their safety and quality performance continuously.
Requirements of Good Manufacturing Practice
GMP audit requirements vary for pharmaceutical, medical, dietary supplements and cosmetics markets. Nevertheless, all of them have a common structure, tailorized more specifically depending on the criticality and market of destination.
Depending on the scope of the audit, our GMP Audit report covers main quality topics such as:
- Quality management, Organization and personnel, Documentation and records
- Complaints - Recall
- Deviations - Corrective Action & Preventive Action (CAPA)
- Product Quality Review (PQR), Audits
- Rejection and Re-Use of Materials, Validation, Change Control
- Suppliers and Service Providers, Quality Risk Management, Facility tour, Storage and Warehouse, Production and packaging areas, QC laboratories, Distribution.
A Product Quality Review (PQR) is typical assessment of a pharmaceutical audit concerning APIs and finished products manufacturers. The Validation program is normally more rigorous in a pharmaceutical audit.
A QP declaration can be easily performed by using our audit reports, when the pharma regulations require it.
In a dietary supplements audit, the focus also includes HACCP system, management of allergens, and food safety.
Good Manufacturing Practice audit by Eurofins
Eurofins has been conducting GMP audits for different customers in the past two decades in different domestic markets.
As a reputable independent audit services provider, our GMP auditors carry out on-site audits that consist of document review, facility assessment, as well as process and policy evaluation to identify gaps against GMP requirements. Both our office and frontline teams are well-versed of GMP requirements and relevant local regulations, customers can expect their professional GMP audit report with detailed findings that provide intrigue insights on the facilities’ performance.
Why choose Eurofins for your GMP audit?
We possess over 25 years of experience in the pharmaceutical and healthcare industry, supporting customers around the world on their compliance journeys. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.
In addition to on-site audit services, thanks to our expertise, we can deliver training and advisory services to better support customers who need extra help in reaching compliance goals. Shared GxP audits and purchase of GxP audit reports are both available online to offer fast and streamlined experience.
When working with us, our professional and customer-centric teams assist you along your GMP audit, and provide your GMP audit reports on time.
Auditing activities are compliant with international regulations such as EU, US, Brazilian, Canadian, and more.
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