Quality assurance services

QUALITY management system (QMS) and quality ASSURANCE (QA) SERVICES for medicines, medical devices and IVDs

Quality management is an absolute necessity to survive as a pharma, medical device (MD) or in vitro diagnostic medical device (IVD) company today. Inspections are carried out by the competent authorities to monitor compliance with quality standards.

If you are in need of consultation regarding quality management systems or quality-related processes, Medfiles’ dedicated Quality Assurance Team is happy to help you. The team has expertise in quality management systems of clinical trials (GCP), pharmacovigilance (GVP), good manufacturing practice (GMP), medical devices and IVDs. Additionally, we offer GxP training and consultation, as well as support in writing SOPs and quality instructions.

By choosing Medfiles you will also receive GDP-compliant expertise and extensive knowledge of pharmaceutical wholesale activities. Our legalised licensed pharmacists can act as responsible pharmacists of pharmaceutical wholesale in Finland, including short-time assignments.

When you need bath certification services for releasing medicines for sale in the EU, please contact us. Our experienced Qualified Persons (QPs) and support teams have extensive knowledge in the pharmaceutical industry. QPs handle various product types and dosage forms, ensuring the consistency and safety of your products.

Pharmaceutical products imported from the so-called third countries are re-analysed in our laboratory, and our QPs can certify batches before they are released to the EU market. Our QP service include QP declaration writing. Our licence also covers manufacturing and certification of investigational medicinal products (IMPs).

Batch certification for IMP and commercial batches is part of our everyday tasks. Having released over 1000 commercial batches, we collaborate with multiple marketing authorisation holders (MAHs) across almost all EU countries.

9

marketing authorisation holders

450+

Released
batches / year

6

QPs and
co-ordinators

20

countries
served

In addition to commercial batches, our QPs release all IMP batches of our own production.

Our QPs have experience of variety of non-sterile products:

  • Tablets
  • Capsules; hard and soft shell
  • Liquids
  • Creams
  • Inhalers
  • Powders
  • IMPs
  • Packaging materials

We can support you with GCP, GDP, PV or GMP audits by providing audit services, assistance and consultation. Medfiles has a pool of internal qualified GxP auditors, available to act as lead auditors or help you as an expert.

Our experienced auditors offer a range of audit services, including:

The entire Medfiles staff is dedicated to maintaining quality standards and undertake a specific and personalised training program. We are always up to date with GxP requirements and aware of coming changes, taking pride in delivering the best quality to our clients.

To ensure a high standard of quality, we organise regular GxP (including GMP, GVP, GCP, GDP) training for our staff related to their responsibilities.

All operations of the business units are based on standard operating procedures – i.e. the SOP system and company policies. Medfiles quality system is maintained, developed and updated in accordance with GxP guidelines and applicable regulatory requirements.

We have an electronic validated quality management system (QMS) in place including SOPs, deviation and complaint handling and change control. Our harmonised quality system ensures that quality work extends to all our operations. In this way, non-GxP functions are also within the scope of the system according to quality standards.

Our quality operations and quality management system are regularly audited by the authorities and our clients.

The experts within our Quality Assurance Team take care of our quality system and collaborate with unit experts to ensure the delivery of high-quality work to our clients.

Our QA Director and QA Managers with decades of GxP experience make sure that the requirements of the regulations are met. The QA Director also works as Medfiles’ responsible director in Finland.

We have a designated QA manager for each GxP area which ensure that the monitoring of GxP requirements remains in expert hands. In addition, we have QA coordinators and assistants taking care of the daily operations.

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