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Laboratory analysis in line with GMPs
Your needs : to call on an analytical laboratory working in a GMP environment providing various services for the pharmaceutical industry
What are GMPs ?
GMPs (good manufacturing practices) are defined by the WHO (world health organization) as “the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification”.
In the pharmaceutical industry, GMPs are very important given the high level of quality that is required during the development, production and monitoring of products.
GMPs cover the notion of quality assurance throughout the development, production and monitoring processes of pharmaceutical products and not just on the finished product.
GMPs apply to pharmaceutical products intended for both human or animal consumption.
For years, competent authorities have been looking to harmonize GMPs worldwide
The ICH Q7, Q8, Q9, Q10 can be fully integrated into GMPs on different levels, such as ICH Q7 which specifies the GMPs for active ingredients (API) or even ICH Q8, Q9 and Q10 which mention the “quality by design” approach for GMPs.
What criteria does an analytical laboratory have to fulfil to fall in line with GMPs ?
A laboratory working in accordance with GMPs must abide by certain guidelines :
- A location up to standards
- Trained and qualified personnel
- Qualified equipment
- Complete traceability via a reliable registration system
- Procedures written out and validated by quality assurance
- A regular internal audit system
Are you looking to cooperate with a reliable and reactive analytical laboratory, working in line with GMPs and abiding by the above guidelines ? Call on FILAB !
Our solutions : to assist pharmaceutical industrialists with expertise services in line with GMPs
At FILAB, we have been carrying out various analyses for the pharmaceutical industry in line with GMPs and regulations for many years. We have ISO 17025 accredited (www.cofrac.fr accreditation n°1-1793) for the analysis of elemental impurities in pharmaceutical matrices. Our clients regularly audit our laboratory in relation with GMPs.
From analysis to expertise, FILAB laboratory is able to provide the following services for the pharmaceutical industry :
- Custom chemical analyses of pharmaceutical products
- Detection of elemental impurities in accordance with the USP 223
- Expertise of pharmaceutical packaging materials
- Problem solving (ICH Q3D)
- Analysis of residual solvents in accordance with the USP 467 (ICH Q3C)
- Analysis of nitrosamines in pharmaceutical products
- Analytical development
- Analytical training and validation (ICH Q2)
- Forced degradation studies on pharmaceutical products or packaging
- Stability testing
- Dissolution testing
- Powder characterization and granulometric analysis
- Extractables and leachables testing
- Analysis of particulate contaminates in injectable drugs
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²