Quality Assurance

Consulting Services

Current FDA standards require that quality systems ensure safe drug manufacturing, distribution and clinical trial oversight; these systems must include established processes for regulatory compliance and risk mitigation.

Often, warning Letters from the FDA or observations noted during an FDA inspection regarding noncompliance or nonconformance are a result of a dysfunctional quality system. Regardless of the specific situation you are experiencing, you need to respond quickly in order to protect the future of your product and company. FSI is able and ready to help you overcome these roadblocks that can occur in the course of your operations.

Major elements that input into the QA system are as outlined in the table below:

Function	Input
Environmental and Occupational Health	• Raw water quality data • Production water quality data • Production area air quality data • Effluent and emissions data • Wall and ceiling swab analyses records • Settler plate assay records
Production	• Production validation data • Batch records • Cleaning validation records • Change control records
QC/QA	• Raw material acceptance and rejection record • Product approval for release and rejection records • Rework approval records
Business Development	• Product distribution records • Customer Service complaint records
Regulatory Affairs/QA	• Self-inspection records • Voluntary inspection records • Mandatory inspection records • Regulatory compliance actions

Water System

A schematic representation of the water supply system is shown below.
The final RO water, used in production, is stored and distributed via an RO loop system, as shown, to the points of use.
The points of use are fitted with zero dead-leg outlets as described below.

Detail of typical RO water loop drop with zero dead leg outlet

Schematic Representation of Material Handling

Schematic Representation of Manufacturing Process

Activity	Documentation for Batch Processing Record