ISO 13485 certified, FDA registered and GMPlicensed
At Valuepack, everything starts with quality. The culture of quality at Valuepack permeates the whole company, from top management to the employees in every department. It is the foundation of all our actions. Valuepack’s quality management oversees all the activities and tasks necessary for maintaining the quality of orders, products, processes, and lead-times. It is made up of three parts: Quality Management System (QMS), Quality Assurance (QA), and Quality Control (QC).
Certifications
Valuepack works according to the highest quality standards that comply with internal policies, national and international standards and regulations. Valuepack is ISO 13485 certified, GMP licensed, and FDA registered. This guarantees a high degree of consistency in the quality of our services, which enables us to meet all our customer’s needs and expectations.
Quality Management System (QMS)
Our quality management system is uniform across all Valuepack locations, and it defines all harmonized processes and procedures with protocols, instructions, and records.
Our QMS is built on the principles defined in GMP guidelines and is in accordance with the international standard ISO 13485. It provides a systematic and risk-based approach that guarantees consistent, efficient, safe, and quality products.
Quality Assurance (QA)
Quality Assurance works on improving quality by taking a risk-based approach. To achieve this, an ongoing training program ensures that qualified personnel work to the highest quality standards. QA also conducts thorough investigations into every occurrence that affects the quality of the product, process, or client satisfaction. Internal audits and quality controls are performed to gain objective information on the performance of the QMS and every process. Finally, all changes in processes are controlled, investigated, and documented.
Quality Control (QC)
Quality control monitors the infrastructure, production, and quality of the product. The main task of QC is to ensure compliance and correctness, and to find any potential issues. Thanks to the checks and reports throughout the production process, every issue is detected early on and solved before it can affect processes further down the line. This ensures we deliver on time.
Quality starts in the parking lot
Infrastructure: Everything starts at the entrance. At Valuepack, our focus extends to everything: not just production and our warehouse. Our constant checks of the surroundings help maintain the outside of our facilities so you get a fantastic first impression of what you can expect as soon as you enter the building.
IQOQPQ Protocol
Calibrated and validated equipment ensures the proper performance and safety of the packed products, which is vital for sterile packaging.
QC is responsible for final product review. All data collected by QC is also used by QA to improve the overall quality of the processes.
Temperature controlled
Production - GMP and medical devices areas
- CNC – Controlled Not Classified – usually used in box packing.
- ISO 7 and ISO 8 – mostly used to handle the products intended to be sterilized.
Since everything starts with the employees, it is important for us to control that through constant environmental monitoring. This includes the proper cleaning of the production areas and correct gowning. We have achieved great microbiological results, showing that our Team follows the procedures to the letter: proof of their commitment.
Checks on the temperature and humidity in our online, validated system help us to ensure the proper conditions for the products being handled at our facilities. Additionally, Valuepack’s conditioned trailers mean we can support our customers with temperature-controlled transportation services.
