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Quality at the heart of our processes

Quality at the heart of our processes

Arkopharma Laboratories strives above all to offer innovative, safe, high-quality products that are designed, manufactured and distributed in compliance with a range of procedural standards and regulations. The Group’s activities involve a series of innovative processes, driven by its quest for progress, meaning that its standards are constantly improving, along with the overall quality of its products.

Manufactured according to the most stringent standards

The purpose of process-based management (defined by an AFNOR standard) is to break down an activity into a series of processes and apply checks to those processes in order to bring them into line with the company’s strategic objectives. There are three types of process:

Processus de Management

“Management” processes, 
which define the strategic choices made by the company, analyze and allocate the required resources;

Processus de Réalisation

“Production” processes,
also known as operational processes, which involve direct contact with customers;

Processus Supports

“Support” processes,
which are an essential part of product manufacture but do not involve the customer directly;
 

Each process is covered by a detailed process sheet and a designated leader. The measuring and monitoring resources are defined in this process sheet. Quality management documentation is represented by the documentary pyramid consisting of—at the top—the Quality Policy Manual, cascading down via the process sheets, procedures, instructions and records.

“This approach to quality aims to instigate good practices that take us beyond the checks made on finished products.” Head of the Quality team

In practice, then, the notion of quality is incorporated right from the start of the design and development process, for all products regardless of type.

The low-down on our quality control laboratory

Arkopharma Laboratories considers its quality control process to be an essential part of its job, in addition to the traditional assessment and inspection activities. It provides independent technical and scientific expertise regarding the quality of our healthcare products and their safety.

Arkopharma’s quality control service currently employs over 60 people, all working towards a common goal: to offer and guarantee high-quality, safe products.

Quality control standards and regulations

  • European regulations and directives for foodstuffs;
  • Pharmacopeias; European, French or other countries (e.g. USP, etc.);
  • Forms and records;
  • ISO and AFNOR standards and procedural documents, Codex Alimentarius, etc.;
  • ICH and EMEA Guidelines.

Analyses carried out

  • Identification (compliance);
  • Concentration of active ingredients (quality);
  • Concentration of any contaminants (pesticides, heavy metals);
  • Microbiological analysis (health and safety compliance).

Techniques used

  • Thin-layer chromatography;
  • High-performance liquid chromatography;
  • Gas chromatography;
  • Infrared spectrometry;
  • Atomic absorption spectrometry.