Lutando para manter o controle de qualidade na fabricação biofarmacêutica?

In order maintain the quality control in any process there will be a standardized protocol upon following gmp there are other parameters to check & maintain the quality especially in biopharma sector with high quality products including stability,appearance,necessity and regularity.

When solid systems and controls are in place, success naturally follows. In biopharmaceutical manufacturing, it's critical to revisit any deviations through the lens of strengthening those systems. Transparency is key! Everyone involved needs to understand the "why" behind each process to drive improvement. Total Quality Management isn't just a buzzword... it's about embedding quality into everything we do, ensuring consistency, compliance, and ultimately, the success of our teams, business, customers, and end users.

Agree! To add, there are other elements as well such as inherent variability, Processes can work on a small scale often need to be adapted or completely re-engineered for mass production without compromising the quality, reliance on Global Supply chain for raw materials, manufacturing process also requires sophisticated technology and equipment, which must be operated by highly skilled personnel. Lack of talent and innovation and adaptation to new technologies adds to the complexity.

To maintain standards there should be proper SOPs and protocols prepared and followed strictly. Checks implemented after time of intervals.

People training, products design, written procedures, validated processes and well-design facility are the key challenges in GMP regulated biopharmaceutical industry. A special project team should be formed to do GMP analysis. Through this GMP gap analysis the team find out the root cause why quality control is having problem to maintain. Plan to work and work the plan toward your quality promised land.

Process analytics helps in improving the process and errors in mere future and adopting new technologies in PAT will improvise the quality & the quantity of the product.sustaining the quality and process control with upholding the procedure and the parameters to maintain according to changes made is important.

Real time monitoring and documentation may lead to accurate and reliable results.ALCOA+++ followed to avoid any deviation/difficulty.

Routine and strict check may lead to avoid any major risks. Identifying risks easy during routine and daily checks and may lead to control major disaster.

O gerenciamento de riscos é essencial para manter o controle de qualidade, pois permite identificar e abordar problemas potenciais antes que eles impactem o produto final. Ao mapear o processo de fabricação e entender as interações entre entradas e saídas, você pode antecipar e mitigar riscos mais eficazmente. A avaliação contínua e a adaptação das estratégias são cruciais para manter a robustez do processo e garantir a qualidade consistente do produto. Este ciclo de identificação, avaliação e resposta a riscos ajuda a criar um ambiente mais resiliente e de alta qualidade.

Process failure mode effect analysis (pfmea) is used to document possible failures that can occur during each step of the manufacturing process. Severity, probability and detection scores are summarized and appropriate actions are weighed according to the failures. Pfmeas are usually reviewed annually and process scores adjusted aligning to field evidence.

Analyst/team member performance is major role in team work.Proper training should be implemented for team members to understand things better.

Tener al personal capacitado y tener al personal con las competencias adecuadas al proceso mejoran la calidad del producto, siempre que se haga alguna modificación al procedimiento es necesario capacitar al personal y mencionar lo que se actualizó

Knowledge and Expertise: Continuous training of personnel to handle highly complex and regulated processes is essential to maintaining quality standards. Retention of Talent: Retaining a skilled and experienced workforce is challenging in such a specialized field. These challenges require an integrated and rigorous approach to quality control, combining technology, regulation, and continuous training to ensure the safety and efficacy of biopharmaceutical products.

Uma equipe bem treinada é fundamental para a manutenção do controle de qualidade, especialmente na produção biofarmacêutica, onde a precisão e conformidade com normas rigorosas são cruciais. Os programasde treinamento contínuo são essenciais para que a equipe esteja sempre atualizada e preparada para lidar com novos desafios e inovações. Investir na capacitação da equipe é, portanto, um passo estratégico para assegurar a qualidade e a integridade dos produtos.

Daily meetings with team members may lead to avoid difficulties in their work and help in continously improvement. Trainings should be implemented for improvement

Buscar siempre la mejora continua de los procesos nos ayuda a optimizar los recursos que se tienen, siempre teniendo 5 min con el personal involucrado para ver puntos de vista diferente e ir mejorando para ser más eficiente con las tareas diarias

Continuous improvement in the Pharmaceutical Industry is critical to ensure your facility and processes remain current with cGMPS. I have found that people get complacent and fall back on the statement "That is the way we have always done ...." forgetting the 'c" means current. cGMPs have evolved since their inception and will continue to evolve. Reviewing inspection reports from within the industry and from other sites and implementing corrective actions helps maintain a state of compliance and keeps your site ahead of the curve. This is the foundation of a proper continues improvement program. Remember to go back after the change is implemented to ensure the actions fixed the issue. Its ok if the change needs to be tweaked.

In order to maintain a good quality of product, training must be standardize before hands on, knowledge GD&T, know how to read print, and understand work instruction. Stability of the process in manufacturing will make a high quality of the product.

Estar siempre a la Vanguardia tecnológica como análisis de datos nos ayuda a visualizar mejor las tendencias de los procesos y mejorar los procesos, ser más eficaces