This area covers the implementation of pharmaceutical requirements for production equipment and its compliance.
Requirements of technical processes
In the development of pharmaceutical products life cycle management enters increasingly to the foreground. This includes in an early phase the transfer of pharmaceutical requirements from development to the technical implementation on the production equipment. Based on many years of experience at a drug manufacturer and a supplier for pharmaceutical equipment, the following services can optimize the implementation of pharmaceutical requirements.
- Consultancy for the development of machines and equipment with the aim to introduce the validation requirements.
- Assistance for implementation of validation requirements from Technical Specifications.
The understanding of the pharmaceutical process minimizes quality risks and creates the prerequisites for a good quality of the product at an early design phase of the manufacturing equipment- Quality by Design (QbD).
Confirmation of Functionality
The technical implementation of requirements for pharmaceutical processes often is within the responsibility of the machine manufacturer.
It is the task of teams with various professional background (mechanical design, automation, ventilation, etc.) to implement the specified requirements of pharmaceutical customers. It is necessary that the functionality of the process can also be demonstrated. This usually ensures the representative from the validation department as specific member of such the team.
Extensive knowledge in the validation of pharmaceutical manufacturing facilities and experiences from various fields enable the provision of these services:
- Training of employees from Validation departments (Basic education, SOP instruction, Training on the Job)
- Educational support for employees with the topic Management of Qualification and leadership for projects.
- Consultancy for Development of new Qualification services or review from existing ones with focus on bio decontamination and aseptic processes.
These services provide a benefit for the validation departments of equipment manufacturers, as well as for drug manufacturers performing the Qualification / Validation with the supporting documentation of the machine vendor by themselves.
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