Purpose
Method validation confirms that an analytical procedure is suitable for its intended purpose and consistently produces accurate, precise, and reliable results.

Our Validation Approach
QACS Labs perform pharmaceutical testing services during and after drug development to ensure GMP compliance and product safety.
Validation studies include the evaluation of key parameters such as:

• Accuracy & precision

• Specificity

• Detection and quantitation limits

• Linearity & range

Regulatory Standards
QACS is a GMP-certified laboratory developing, validating, and issuing analytical methods according to EMA and ICH guidelines. Quality planning ensures all studies are carried out on optimized, calibrated equipment by skilled analysts experienced in pharmaceutical method validation.

Purpose
Method transfer ensures that a validated analytical method can be reliably reproduced by another laboratory, with equivalent performance and consistent results.

Our Process
QACS transfer method protocols verify that results generated by the sending and receiving laboratories meet predetermined acceptance criteria.

• The transfer protocol is prepared by the Project Coordinator.

• Reviewed by the Laboratory Manager and QA Manager.

• Approved prior to execution.
  The final report summarizes the study results, confirming the method’s successful transfer.