How can you integrate quality control into biotechnology R&D?

Es algo crítico también tener en cuenta el balance entre los objetivos de calidad que fijemos y la productividad. Debemos asegurarnos bien de sincronizar y conseguir los llamados compromisos de calidad, que nos aporten valor y hagan que desarrollemos soluciones a necesidades. Plantear unos buenos objetivos nos permitirá alcanzar la excelencia a través de una mejora continua.

This is a broad topic. QC plays a role in multiple GxP. I will focus on GCP as my specialty, although GMP requires strong QC too. For GCP, you need a Quality Plan for your clinical trial. Part of the plan is QC. For example, you will want to have QC check of critical clinical documents. That would be included in your Quality Plan as an objective and action. Ensure you have an SOP or Work Instruction to provide a process for QC before starting a clinical study.

It is important to determine what level of accuracy and precision is needed for each particular assay. There is no need to reduce error by 10% of gene editing assay if the error is already negligible. Some assays may have high error due to the inherent chemistry of the assay.

Clearly state the requirements and standards of quality for your biotechnological processes or products. Setting requirements for safety, potency, purity, and other pertinent factors is part of this.

Before you establish metrics, the most important question is whether an assay is needed at all. In my experience in biologics production, sometimes things were measured that had no impact of patient safety or efficacy. Once an assay is deemed necessary, the key is to measure relevant parameters. There is no point to have a highly reproducible assay that has poor accuracy.

Los indicadores deben marcarnos patrones y tendencias. Esto nos permitirá la evolución del proceso y a la vez controlarlo. Establecer una métricas útiles requiere de conocimiento y experiencia. Si las conseguimos, aseguraremos y mejoraremos el proceso.

Definir acciones correctivas y preventivas adecuadas pasa necesariamente por haber definido y establecido correctamente las responsabilidades en el equipo. Es importante que cada uno sepa que datos debe tratar y como complementar las contribuciones de los distintos miembros del equipo. Sólo yendo en la misma dirección, como equipo, se lograran objetivos que conduzcan a la excelencia.

Executing a QC plan in biotechnology R&D involves several critical steps: adhering to regulatory standards, ensuring management commitment, defining and communicating quality policies, managing resources, maintaining effective internal communication, and conducting periodic system reviews. This ensures the integrity and safety of research and products, aligning with industry practices like the FDA's guidelines for good manufacturing practices. Such rigorous QC protocols are essential in maintaining the quality and reliability of biotech innovations.

Create procedures for preserving the documentation and data integrity. Maintain thorough and precise records of all experimental setups, outcomes, and departures from accepted practices.

Establish a reliable system for managing and tracking samples in order to guarantee traceability all the way through the R&D process. To find the source of any quality problems, this is crucial. Encourage a culture that is always improving. To improve the effectiveness and caliber of research and development procedures, solicit input from colleagues, examine data patterns, and make necessary adjustments.

You may improve the repeatability and dependability of your biotechnology research and development by incorporating these quality control procedures, which will ultimately aid in the creation of secure and useful biotechnological goods.