Engineering & Validation
Defining the User Requirements Specifications (URS) for facilities, Utilities and equipment.
Conceptual Design of manufacturing facilities and production lines including personnel, material and waste flow.
Design new facilities and redesign existing facilities in order to suit the GMP and operational needs.
Submitting the Design to the Ministry of Health (or other regulatory authority) to obtain the GMP approval.
Writing the Basis of Design(BOD)
The BOD document describes the basic concept of the facility/system and provides the required rationale for it.
Supporting the detailed design of critical utilities
Supporting the detailed design of critical utilities: HVAC systems, Clean rooms, PW, WFI, Pure Steam, Compressed Air, N2, CO2, O2, Ethanol and solvents supply.
Perform detailed design review for critical systems and participate in the design review process.
GMP supervision of facility construction
Perform GMP inspections during the Establishment phase of the facility to ensure the detailed design is met prior to handover.
Writing and performing commissioning protocols prior to the validation in order to ensure proper handover by the supplier.
Process Design and development
Develop commercial scale process design.
Design of production lines including choosing the right equipment and utilities.
Supporting Tech Transfer.
Defining critical aspects of the process and design of the necessary means of control.
Writing SOP's for utilities and systems
Writing SOP’s for operation, cleaning and maintenance of systems and equipment.
Performing risk analysis in order to identify and mitigate all the risks within the facility/process/systems/equipment. The analysis supports the conceptual design and defines the extent and scope of the validation.
Defining the Validation Policy and Master Plan (VMP)
Identifying all validation activities within the manufacturing facility throughout the validation life cycle.
Defining the overall validation strategy and procedures. The outcome of this process is the validation plan of the facility.
Performing Design Qualification (DQ)
Reviewing all the detailed design documents and specifications in order to verify compliance with the relevant regulatory requirements as well as the user specifications.
Plan and execute qualification activities for systems and equipment
Writing all validation protocols, execution and writing validation reports for systems and equipment.
Coordinating all the activities involved in the validation process,managing the whole operation including subcontractors, deviation resolution and quality impact assessment.
Process Validation(PV),Cleaning Validation
Design and develop the process validation protocol and plan.
Accompany the execution and write the validation report.
Instruction and training of validation engineers at all levels
Customized validation training courses for engineers and validation/engineering managers at all levels.
Inspection mock audit and Gap analysis
Preparing validation departments from a subjective point of view for external audits by FDA/MOH.
Performing mock audits / Gap analysis for engineering and validation departments.
Studying the existing activity of the department from an external point of view and preparing a gap analysis and mitigation plan.
Accompany the client through external audits.