Quality Control for GMP Manufacturing

Quality Control (QC) is required in many critical steps of the GMP Manufacturing process. Raw materials used in the manufacturing of bio/pharmaceuticals must undergo QC prior to inclusion in the process. The entire production process requires a QC standard operating procedure (SOP) to ensure the possibility of contamination is neutralized as much as possible. Lastly, the final product must undergo QC to ensure it meets specifications and quality standards of the original drug manufacturer.

raw materials WFI treatment facility bioreactor production bulk drug product final product cleanroom drug stability formulation testing final product quality control

API / Excipient Powder Granule Sizing

Active Pharmaceutical Ingredient (API)/ Excipients Powder Granule Sizing pill drug powder

Formulations include APIs, excipients (non-active ingredients), such as diluents (an active filler to achieve a reasonable final pill size), and disintegrating agents to regulate the tablet’s dissolution time after administration. These materials need to be sized for consistency.

Bioprocessing / Cell Culture

bioprocessing cell culture mammalian cells

Within bioprocessing there are two QC processes. One is Production QC where technicians ensure the cells are growing and their media fits within specified ranges for cell growth. The other is Product Efficacy QC, where assays are run to test the efficacy of the drug prior to distribution.

Clean in Place (CIP) Processes

industry satandard usp 643

Keeping the bioreactor environment clean is critical so regulators insist that, where possible, bioreactors need to be cleaned in place (CIP) after production.

Environmental Monitoring

cleanroom technician using filter probe for environmental monitoring air particle counts

Good Manufacturing Procedure (GMP) mandates the air quality conditions for biopharmaceutical production in cleanrooms

Final Product Quality Testing

final product quality testing QC FOR INJECTABLES/PARENTERALS

QC for injectables/parenterals is critical because when performing final quality testing for injectable drugs, it’s easy to contaminate samples and produce costly errors in Pass/Fail calculations

Small Molecule Insulin Formulation

small molecule insulin formulation vial and needle

The bioavailability of insulin analogs is strongly dependent on not only the primary structure of the analog but also the formulation. Here, AUC can be leveraged as a potential tool to analyze the higher-order structure of insulin under typical formulation conditions.

Water Release Testing for GMP Manufacturing

industry standard usp 645 image

The quality of the water used in manufacturing is defined by the global Pharmacopoeias who have harmonized the parameters and requirements for Purified Water (PW) and Water for Injection (WFI).

Viral Vector Characterization

adeno associated virus aav viral vector

Analytical ultracentrifugation excels at determining the percent of viral capsids that are intact and how many of those intact capsids carry transgenic cargo.