Change Control Support

Pharma company with a large portfolio of prescription medicines with more than 160 active ingredients. This allows it to cover a large range of indications, which translates into astonishing numbers: In 2016, over 14 million packs of prescription medicines made it into the homes of patients. Each and every pack of the affordable medicines contributes directly to lowering the cost of the healthcare system.

About the project

The project involved ALTEN expertise with proven experience in Quality Assurance acquired over the years partnering with Key leading Life Sciences players.

After an initial analysis phase of the client’s business processes, part of the team focused on reducing process deviations already open, actively collaborating with the entire company organisation to obtain the necessary information and to process the related reports in accordance with internal client procedures

The focus later shifted to new deviations and implementing Change control and CAPA management ressources.

From ALTEN we have contributed our experience in GMP and quality assurance, in the review of batch records, in quality management systems, as well as our knowledge of the applicable standards and regulations.

  • Batch Record Review (BRR)
  • Batch release for sale (ACS, SAP)
  • Deviations management
  • Change control management
  • Complaints management
  • CAPAS management
  • Documentation management (including marketing authorization dossier updates)
  • Providing training on GMP, Quality Assurance and BRR