GMP

Capsulit operates in the full respect of GMP (Good Manufacture Practice)

Norms, following carefully all the rules, procedures and guidelines, object of ISO 15378 certification.
In the same context, every aspect of the production process is documented in detail, thus ensuring a level of quality that meets the demanding requirements of the pharmaceutical industry.

GMP procedures (Certification ISO 15378)

Quality Assurance (change control, management of documents, CAPA, audit, regulatory support)


Production areas (double doors, pest control, personal wearing, premises cleaning)


Line clearance and labels reconciliation


Validation of machines, validation of processes, risk assessment


Training

Batch release

Batch record re-examination
Batch approval
Quality Certificate


Traceability

Batch-record traceability guaranteed for 6+1 years
10 years for CDE Marking
Countersamples kept in proper store rooms for 5+1 years