• Validation Master Plan
Our Validation Master Plan, outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility.
• IQ support
Our IQ service verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. We also provide complete support for installation of systems
• OQ Support
Our Operational Qualification service includes a review of the Standard Operating Procedure (SOP's) for start-up, operation, maintenance, safety, and cleaning / sanitization as applicable, all in a fully approved format.
Our service includes verification of a given equipment and checks consistently if it produces the product (or product part) within defined specifications.
• Process Validation
Our Process Validation service includes analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products as per given regulations.
• Cleaning Validation
Our Cleaning Validation service assures that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.