APG obtains ISO 15378 certification, the first in Italy for secondary packaging of pharmaceutical products

Due to the many risks of contamination, packaging materials for pharmaceuticals require great care in production and controlled manufacturing processes. Implementation of a more sector-specific management system to ensure that Good Manufacturing Practices (GMP) are employed allows packaging manufacturers to comply with their clients’ needs, increasing the level of trust.

Hence, APG’s decision to integrate its ISO 9001 certification with the ISO 15378 (Primary packaging materials for medicinal products) standard in its specialized division for production of boxes and labels for the pharmaceutical, food and consumer packaged goods market, making it the only secondary packaging company in Italy to have it.

ISO 15378 certification requires compliance with some very restrictive key principles regarding:

  • human resources (organizational structure, training, hygiene and health);
  • management, cleaning and maintenance of the workplace and equipment;
  • purchase and control of raw materials and packaging materials;
  • production, packaging and release of the product;
  • management of nonconforming, reworked and recalled products;
  • management of errors and change control;
  • improvement plans based on analysis of data concerning errors and complaints;
  • documentation (procedures / process instructions / data recording) necessary for proper management of work processes.