Validation

An essential element in demonstrating manufacturing processes and its connected equipment, test methods, facilities, and utilities consistently produces product that meets the pre-determined specifications.

Biotech Solns Int’l validation services include developing and/or executing the Validation Master Plan, Equipment, Test Methods, Cleaning Validation, Computer Validation, and Facilities & Utilities Commissioning/ Validation.

Master Validation Plan

A document/or record that identifies a roadmap that outlines the process validation requirements and justifications for these requirements, and the interrelationships between processes requiring validations and timing for revalidations.

Equipment, Test Methods, Cleaning Validation, Computer Validation

Installation (IQ), Operation (OQ), and Performance (PQ) qualification protocols and reports which demonstrate that the equipment is properly installed for use and can consistently manufacture acceptable in-process and final products that meet specifications under all anticipated manufacturing process parameters including worst-case conditions.

Facilities & Utilities Commissioning/ Qualification

Commissioning protocols and reports which demonstrate that the facilities, systems, and equipment suitable for intended use performs properly meeting established design requirements.

Qualification protocols and reports which demonstrate that the facilities, systems, and equipment suitable for intended use performs properly meeting established design requirements and acceptance requirements with GMP impact consideration when applicable.

Process Performance Qualification

Protocol and reports which demonstrate the entire manufacturing process for a product from beginning to end, including sub-processes, can achieve specifications with a high degree of assurance to justify commercial distribution of the product.