Product & Process Division
Dedicated Team for able to offer a wide range of services
DOC global offers are not only limited to the qualification of equipment and systems; thanks to a dedicated Team of Project Managers consisting of Biologists and Biotechnologists with consolidated experience on the field, DOC is able to offer a wide range of services that encompass the Development and Validation of Sterile and non-Sterile Processes up to the Qualification of Pharmaceutical and Cosmetic finished forms.
For all these activities, DOC is fully capable of handling any kind of product formulation from the Active Pharmaceutical Ingredients (APIs) up to Cytotoxic and Controlled drug substances and their precursors. The laboratory structure in which our tests and studies are executed is GMP, GLP qualified and FDA approved since 1997.
Our Process Validations take into consideration the reproduction of the actual manufacturing operation from the small scale of Clinical and R&D processes to long and complex process campaigns.
For every project, a dedicated Project Manager is assigned and will be responsible to assist you in the job development up to its completion.
Our Project Management assistance includes:
- Logistic arrangement
- Study approach definition in compliance with the specific regulatory requirements
- Elaborate and development protocols and/or the necessary Documentation
- Plan, monitor timelines and supervise Project execution
- Provide regular updates
- Laboratory raw data collection, review and interpretation
- Out of specification support, troubleshooting, trendings, etc..
- Support to regulatory inspection/audit (if requested)
The division provides validation and qualification services focused on the main different areas:
- Process Validation
- Primary, Secondary and Tertiary Packaging
- Finished Pharmaceutical Product
Validation meets the international regulatory compliance requirements
DOC performs validation for new or already existing processes, in case of process improvements or changes to introduce into your manufacturing area. Our study approach is designed in order to meet the international regulatory compliance requirements for process validation. Each process validation will vary in its scope, based on the reason for the validation, criticality and complexity of the process and associated equipment.
Primary, Secondary and Tertiary Packaging
Validation for the packaging
Pharmaceutical Primary, Secondary and Tertiary Packaging are the final keeper of the pharmaceutical drug formulation and represent the physical barrier between the external environment and the final patient. It is fundamental, therefore, to qualify the performance and the features of the material constituent of the containers from the early stages of their developments up to the final verification at the end of product shelf life.
Finished Pharmaceutical Product
Expertise and Services capability supports you up to the final stage
DOC Expertise and Services capability supports you up to the final stage of your operations: the final pharmaceutical product release or the late phases of its developments. Studies or release analysis are carried out under the full GMP compliance to guarantee your same Quality Standards.