Assurance and Control

Our Quality Team combines Quality Assurance and Quality Control. The teams is comprised of 16 units, whose objective is to ensure the highest level of production quality through continuous improvement of our processes.

Our chemicals laboratory is fully equipped with all necessary equipment to conduct raw material, semi-finished, and finished product testing. Specifically, the lab is equipped with:

• HPLC
• UPLC
• GC
• UV
• FT-IR
• KF
• Potentiometric Titrators
• TOC Analyzers
• Dissolvers
• pH Meters

Stability testing takes place within climate-controlled environments compliant with ICH guidelines: 25°C/60% HR, 30°C/65% HR, 40°C/75% HR. Lower and higher temperatures and humidity may be used upon client request or for special validation procedures and different climatic zone.

The Quality Control department performs all of the following:

• Development and validation of analytical methods;
• Validation of cleaning processes;
• Holding‑time studies;
• ICH Stability study;
• In-use stability study;
• Stress test study;
• Archival and management of counter samples;
• Any further studies required for the technology transfer.

The Microbiology lab is responsible for conducting all testing as outlined in the client’s registration file and is responsible for conducting all necessary environmental sampling and analysis.

The microbiology lab:

• features an environment designed for handling pathogenic microorganisms required by the pharmacopoeia for microbiological testing;
• incorporates its own data into stability studies;
• performs microbiological method validation as requested by clients or prescribed by pharmacopoeias;
• conducts environmental analysis for the microbiological monitoring of the premises and air in the manufacturing departments, in addition to the water used in the manufacturing process.

Our Quality Assurance Department employs a team of highly skilled experts that specializes in the following key elements:

• SOP (Standard Operating Procedures) Management;
• Master Batch Record issuance;
• Batch manufacturing records review;
• Change control, Process Deviations, and CAPA;
• Process and Equipment Validation;
• Supplier Qualification;
• GMP Training;
• Client complaint management.

We also provide the following upon client request: Product Quality Review (PQR), ICHQ3D Risk Assessment, and Nitrosamines