Value added services

Our analysis and certification activities for imported medicines

Movianto manages the entire supply chain for pharmaceutical products and has a department specialised in batch certification. This is an essential step in getting your imported pharmaceutical products onto the European market.

Movianto provides import, analysis and certification services for human and veterinary products throughout the European market, thanks to the status of some of its sites in France as pharmaceutical establishments.

To enable distribution on the European market, Movianto’s quality control laboratory analyses imported pharmaceutical products.

Additionally, Movianto has a dedicated batch certification service. Certification plays a vital role in ensuring that imported pharmaceutical products can be released on the European market in compliance with current pharmaceutical regulations (annexes 16 and 21 of the Good Manufacturing Practices).

Movianto manages the end-to-end distribution chain for medicines, from end of production by manufacturers outside the European Union to distribution. This is made possible by its interconnected activities as logistics provider, operator and certifier.

Our certifications

Our Saint-Amant-Tallende facility in France is accredited in accordance with Good Manufacturing Practice (GMP). It is also ISO 9001 and ISO 45001 certified.

Our team benefits from continuous training in healthcare industry processes, backed up by pharmaceutical mentoring and in-depth knowledge of the latest standards in force.

Saint-Amant-Tallende GMP certificate

Download the certificate

ISO 45001 certification for Saint-Amant-Tallende

Our expertise

With over 40 years’ experience and a highly qualified team of pharmacists and technicians, our quality control and batch certification laboratory services guide laboratory customers in entering the European market. Our portfolio today comprises 90 products in a variety of pharmaceutical forms (tablet, capsule, sterile, powder for oral suspension, etc.), giving Movianto a wide range of expertise.

As a key player, we offer bespoke solutions for our customers.

Contact our experts

Movianto Quality Control Laboratory

Movianto has its own quality control laboratory in France. This 300 m² facility is exclusively dedicated to analysing pharmaceutical products (human and veterinary). The analyses carried out in the quality control laboratory serve to guarantee the composition of pharmaceutical products.

Expanded in 2022, our quality control laboratory is packed with essential technologies to meet the very special needs of our customers.

At Movianto, we continually upgrade the skills of our dedicated team in all aspects of molecule-specific techniques and expertise. We also offer in-house training in Good Manufacturing Practice (GMP), in various analytical techniques, and in the European Pharmacopoeia. Our team deploys customised solutions by adapting our partnerships and equipment to our customers’ requirements.

300

10 HPLC units (UV and RID detectors)
2 gas chromatography (GC) units (liquid injector and head space)
3 spectrophotometers: 1 IR – 2 UV/visible
3 dissolution baths (type 1 and type 2)
Karl Fisher for semi-micro-dosing of water
Durometer
Automatic disaggregator
Friability apparatus
Class D controlled atmosphere area for microbiological controls

List of physico-chemical controls:
- Transfer of analytical methods
- Control in accordance with parts 3.2 P 5.1 and 3.2 P 5.2 of marketing authorisation dossiers for the release of batches of proprietary medicinal products manufactured outside the EU.
- Dissolution tests according to PE 2.9.3
- Disaggregation of tablets, capsules, suppositories and ovules
- Semi-microdosing of water in accordance with EP 2.5.12
- Galenical tests
- Full monograph in accordance with the European Pharmacopoeia

List of microbiological controls :
- Validation of microbiological control methods
- Microbiological control of non-sterile products in accordance with PE.2.6.12, 2.6.13 and 2.6.31)
- Titration of antibiotics by diffusion in accordance with PE 2.7.2
- Assessment of the effectiveness of antimicrobial preservation 5.1.3
- Microbiological control of cosmetic products in accordance with AFNOR standards (enumeration and search for specific germs)

Certification of batches

The batch certification procedure is used to ensure that lots are released throughout the European market in compliance with the marketing authorisation dossier. More than 1,300 batches are certified each year by Movianto’s team of pharmacists and quality managers.

Prior to certification by an authorised pharmacist, a physico-chemical and microbiological analysis of products manufactured outside the European Union is required. This analysis can be conducted by our quality control laboratory.

The certification process includes :

Drawing up technical agrements(upstream work with the laboratory)
Verification of compliance between the product manufacturing master and the marketing authorisation file, including a regulatory review of the product
Analysis of deviations and out-of-specification investigations
Verification of transport data
Checking packaging artworks(ADC)
Verification of physico-chemical and microbiological analysis certificates
Administrative release

1300

lots certified each year

Product quality review

Every year, Movianto undertakes a product quality review for each pharmaceutical product for which it acts as UE releaser. This review records all the events that have occurred at the manufacturer outside the EU and at Movianto for a product during the defined period. It meets the requirements of GMP chapter 1 and annex 21, thus providing our laboratory customers with a transparent overview.

Our team keeps close to the field: audit of a manufacturing site outside the EU

Movianto can also offer an audit service for manufacturing sites to qualify them for the market roll-out of a pharmaceutical product, or to carry out routine audits. This way, our team works directly with producers to ensure the smooth management of our laboratory customers’ products.

In January 2024, part of the Movianto team travelled to conduct an audit of a manufacturing site.