Quality Control in the Pharmaceutical Industry – far beyond inspection

Quality Control is a vital part of the Pharmaceutical Industry, a process that must be involved in all decisions regarding product quality. This is why a robust Quality System is essential for anyone producing pharmaceutical and healthcare products. Read the article below to know more about this process and how RC REDOL can make a difference in your company.

As we said, Quality should encompass all decisions regarding product quality. More specifically, Quality Control refers to the process of verifying compliance with certain quality standards and specifications regarding a product or service. This requires inspecting and testing the product or service in order to identify any defects or deviations from the required quality and, where necessary, to take corrective action.

In the Pharmaceutical Industry, Quality is not limited to laboratory operations but must be involved in all decisions that may influence the quality of the product. It is therefore necessary for each entity to have an independent Quality Control Department under the authority of a person with qualifications and experience appropriate to the technical needs of the process to ensure that the quality of the products or services is not compromised.

Adequate resources must also be made available to guarantee the performance of the quality control procedures. In fact, the pharmaceutical quality control laboratory performs one of the most important functions in pharmaceutical production and control and this is reflected in the cGxP regulations, where a significant part of the 21CFR and Eudralex Volume 4 legislation relates to the quality control laboratory and product testing.

Quality Control as a whole also has other functions. Part of these functions is to put the quality control procedures into practice, but also to supervise the control of reference and/or retention samples of materials and products, to ensure the correct labelling of material and product containers, and also to ensure the monitoring of product stability. This department also participates in the investigation of complaints related to product quality and also performs various other functions related to the control of the manufacturing, packaging, and dispatch processes of the products. All these operations must be carried out and recorded in accordance with written procedures so that all the data can be used to manage the quality of a pharmaceutical product and to support the processes to be inspected.

Also, in Quality Control there is not just one need or form of assessment, as the laboratory inspection may be limited to specific issues or include a comprehensive assessment of the laboratory’s compliance with cGxP. Each pharmaceutical quality control laboratory should receive a comprehensive cGxP assessment as part of the legal obligation to inspect and in general, these inspections should include:

– The specific methodology that will be used to test a new product

– A comprehensive assessment of the laboratory’s cGxP compliance

– Specific aspects of the laboratory’s operations

The creation, management, and performance of an effective and efficient Quality Control Department is a demanding activity, which needs specialized knowledge. It is also necessary that those who carry out production, analysis, and decision-making tasks obtain the information required for the smooth running of that department. RC Redol can play a decisive role in this scope so that your operations have a robust Quality Control Department and Quality System, that performs Quality Control with high performance and is adapted to the particularities of your company and your production process.

From the outset, we assist in implementing the Quality System and preserving data integrity, activities with high technical requirements in which the know-how and experience of our technicians can be decisive. Also, in the several Quality System implementation tasks, RC REDOL can make the difference, giving basic training to analysts in several techniques, establishing procedures for document review, creating personalized logbooks, and creating the necessary procedures for the preservation of data integrity.

RC REDOL team is composed of specialized technicians with vast experience and knowledge, who make a difference in our partner companies. Count on us to achieve the same exceptional result.

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