GMP

Good Manufacturing Practices

GMPs are regulations that guarantee products are always manufactured and monitored according to the quality standards applicable to their intended use, as required by the marketing authorization. GMP regulations address sampling procedures, specifications, analyses, documentation, and distribution, thus ensuring that materials are not used and products are not offered for sale or stored if their quality is deemed unsatisfactory.

Good manufacturing practices (GMPs) in quality control

The purpose of GMP regulations is to help us ensure that products meet marketing authorization requirements and pose no risk to consumers. To meet this objective, we have implemented a total quality assurance system that guarantees all stages of our manufacturing process are documented. This allows us to monitor their efficiency.

Here are two examples of the quality control process:

  1. Reception of raw materials
    Raw materials are not unloaded until our quality control team has performed the required tests. Samples of each batch we receive are kept for six years.
     
  2. Dye monitoring of pharmaceutical products
    We perform strict tests to monitor the percentage of dye added during container production in order to protect the integrity of the products the containers will come into contact with.

Good manufacturing practices (GMPs) in production

From raw materials purchase to finished product delivery, every stage of our manufacturing process complies with operating procedures and standards inspired by good manufacturing practices.

Here are a few examples:

  • Our staff take part in a training plan aimed at efficient container production.
  • We also ensure that their training files are monitored.
  • We manufacture our products in facilities that are kept clean and insect-free.
  • We use certified equipment and tools to manufacture our containers.
  • The raw materials we use are tested by the Quality Control Department, labeled, and then stored in designated areas.
  • The work methods we use to produce our containers are certified and approved.
  • We ensure batch traceability.
  • We document the testing and measurements of finished products during production, before shipping.
  • We have a reliable preventative maintenance system for our plant and equipment.
  • We have a closed-loop system to prevent cross-contamination.
  • Our hygiene program requires that employees wear hair and beard nets, wash their hands, and keep the workplace clean.
  • Work that generates dust, such as regranulating, is performed in a room separate from the production area.
  • To ensure the integrity of finished products and prevent commingling, products are stored in a clean, well-organized area.
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