Achieving Compliant Batch Release – Sterile Parenteral Quality Control

Demonstrating compliant final product release for a sterile parenteral batch requires the use of Quality Control (QC) instrumentation that share certain common key elements. Of course each QC instrument must complete the requirements laid down in the pharmacopoeias or GMP, but in addition each instrument should be optimized to underpin compliance, help reduce human error and maintain data integrity for the test results. This paper describes those common QC instrumentation elements and gives examples of best practice for instruments used for compliant QC batch release.