Product & Process Division
A dedicated team that can offer a wide range of services.
A dedicated team that can offer a wide range of services.
At DOC, our global offering isn't just limited to the qualification of equipment and systems. Thanks to a dedicated team of Project Managers, who are all Biologists and Biotechnologists with considerable experience in the field, we can offer a wide range of services that include the Development and Validation of Sterile and non-Sterile Processes, up to the Qualification of Pharmaceutical and Cosmetic finished forms.
In all these enterprises, DOC is capable of handling any kind of product formulation, from the Active Pharmaceutical Ingredients (APIs), through to Cytotoxic and Controlled drug substances and their precursors.
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.
Our Project Management assistance includes:
- a-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, trends, etc..
- Support to regulatory inspection/audit (if requested)
The division team provides validation and qualification services focused in the following main areas:
- Process Validation
- Primary, Secondary and Tertiary Packaging
- Finished Pharmaceutical Product
Process validation
Process validation
Our validation meets the international regulatory compliance requirements.
DOC carries out validation for already existing processes, as well as those that are new. This is in case there have been improvements or changes made in those particular manufacturing processes. Our study approach is designed 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, and the importance and complexity of the process and the equipment involved.
Focusing mainly on pharmaceutical and cosmetic liquid applications, DOC is able to offer the following Validation Services:
Process Qualification Study
- Tubing
- Connection
- Process equipment, or material in contact with the pharmaceutical formulation
- Single Use System Validation
Process Optimisation Study
- Screening
- Filterability
- Scale-up studies
Product and Process Filter Validation
- Compatibility Studies
- Extractables and Leachables Studies
- Adsorption Studies
- Viability Studies (using reference standard and bioburden isolate microorganisms)
- Bacterial Retention Studies (using reference standard and bioburden isolate microorganisms)
- Toxicological Evaluation and Assessment
Cleaning Validation
- Validation Master Plan
- Risk Assessment
- S.O.P. Development and Review
- Cleaning Validation Protocols and Reports
Validation for the packaging
Pharmaceutical Primary, Secondary and Tertiary Packaging are the final stages of the pharmaceutical drug formulation, protecting the product from the environment and providing the touchpoint with the patient. It is therefore important to test every aspect of package performance, including the material used, from the beginning of development to final verification at the end of product shelf life.
