Your client doubts the quality of your biopharmaceutical product. How will you address their concerns?

A few other key verification points to ensure Quality are the following: Equipment design and operational qualification Cleaning validation Process validation Ongoing monitoring of process and cleaning

Primeiramente e ter fornecedores de confiança e ter uma rastreabilidade da matéria prima desde sua produção no fornecedor até chegar a alinha de produção mantendo sempre um rigoroso sistema de rastreabilidade no processo de formulação, esterilização, inspeção e embalagem e na entrega do produto assim garantindo sua integridade e qualidade até chegar ao paciente.

we emphasize our use of SAP, LIMS, and TrackWise to ensure real-time documentation, traceability, and adherence to standardized procedures. SAP provides visibility into production data, ensuring compliance from raw materials to final output. LIMS captures lab test results and quality checks, ensuring transparency. TrackWise manages deviations and corrective actions, enabling continuous improvement. These systems allow us to provide full documentation, ensuring that our product meets regulatory and client quality standards.

Regulatory compliance will plays a crucial role to helps address client concerns over the quality: #1. Compliance with Regulatory Authorities such as the FDA (U.S.), EMA (Europe), and Health Canada (Canada) have stringent guidelines and standards for development, manufacturing, and marketing. #2. QA and Testing: Detailed QC data ensuring consistency in each and every production batch. #3. GMP and Quality Systems. #4 Risk Management to build quality into the product design and manufacturing process. #5 Post-Market Surveillance to monitor the long-term safety and efficacy once they are available to the public. This will builds trust and provides assurance that the product is safe, effective, and of high quality.

Para garantir esse qualidade temos que seguir todos os padrões de formulação, esterilização inspeção e embalagem seguindo todas as especificações que a ordem de fabricação.

We ensure strict adherence to global standards such as Good Manufacturing Practices (GMP). With a team experienced in filing and managing audits from FDA, EMA, NMPA, and many others, we can assure customers of the product quality.

We ensure strict batch consistency throughout production. This is achieved through well-established protocols that control every step, from raw material sourcing to final packaging. We utilize advanced systems like SAP to monitor each batch in real time, ensuring uniformity in ingredients, processes, and conditions. Regular in-process testing through LIMS verifies that quality standards are met at each stage. Any deviations are captured and resolved immediately using TrackWise, ensuring consistent quality and reproducibility across all batches, reinforcing product reliability. Staff are trained in batch handling and data entry, and the use of digitized form/logbook minimizes error in data entry

Quality of the raw materials is very essential step since it determines the end product. Adhering to laid procedures ensures consistency in batch manufacturing. Having In process checks throughout the production process is very key to ensure quality of the product. Stability studies also help in monitoring the product behavior throughout its shelf life.