Quality2

The holder of an authorization for the manufacture of medicinal products must produce them in accordance with the intended use, the standards of the registration dossier and without constituting a risk to patients due to lack of safety, quality or efficiency.

The concept of security has evolved significantly over the last years.

In the past, it was essentially an activity of analytical chemistry (Quality Control, QC), initially only on the finished product, and then also on samples during production. When the QC detected a result outside the specifications, the anomaly had already occurred. Quality Assurance (QA) has been introduced gradually as an approach based on total quality.

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This approach guides operational activities and participates in the suppliers qualification, inspection and sampling of raw materials, monitoring of manufacturing, packaging and distribution to wholesale distributors, validations, managing non-conformities, changes and risks, internal/external audits, quality reviews, ensuring the maintenance and respect of the quality management system. It sets up a quality management system that will proactively be able to have confidence in the results to be achieved and will ensure the reproducibility through process control.

The laboratory work remains important and analyses are carried out on all the materials that make up the medicinal product, including the packaging. Physical, chemical and microbiological tests are carried out to verify that the products are made in compliance with the specifications filed at the registration.
The physiognomy of the laboratories is rapidly evolving: the automation of measuring methods is applied to the different tests done on the product.
The computer system manages the devices, which makes it possible to eliminate the most routine part of the work and to better process the many data available.

It should be noted that computer systems must be validated. This is an additional task for quality assurance services.

Like production, quality is an activity that is well in line with the polyvalent training of the industrial pharmacist. He will have to face many challenges encountered in the laboratory or in the factory.

Frequently, pharmacists define the company's quality strategy and make it possible to implement it. As already mentioned, this strategy is increasingly based on risk which means that high-risk operations are the most controlled. The multidisciplinary training of the pharmacist is an asset to quantify the various risks and to optimize the validation efforts within the company.