Pharmaceutical Release Testing Services (cGMP)

Compendial methods are standardized analytical procedures published in official pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). They are used to test a drug product or substance against its official monograph specifications.

Yes. Although the method is considered validated by the pharmacopeia, the receiving laboratory must perform a method verification to demonstrate that it can successfully execute the method and meet the acceptance criteria under its specific laboratory conditions (e.g., personnel, equipment, reagents).

The acceptance criteria for compendial methods (e.g., USP, EP, JP) are pre-established by the pharmacopeia itself and are not set by the testing laboratory. These criteria are defined in two categories: the Product Specification Limits found in the official drug monograph and the System Suitability Test (SST) Criteria found in the method itself. The testing lab verify that they can meet these existing criteria.

System Suitability Testing (SST) is a mandatory quality control check required by pharmacopeias to ensure the entire analytical system is working correctly at the time of analysis, using criteria like Relative Standard Deviation (RSD) for standards. In compendial method verification, meeting the SST acceptance criteria is the critical requirement that proves the testing lab can perform the method and that the resulting sample data are valid.

A custom validated method is required when a drug substance or drug product does not have an official compendial monograph, or when a compendial method is deemed unsuitable and a client-specific method is developed for better specificity, sensitivity, or workflow efficiency.

The method must be supported by a full method validation report, confirming its suitability for the intended use according to ICH Q2(R2) guidelines. This method must demonstrate accuracy, precision, linearity, range, specificity, LOD, and LOQ.

Yes. We specialize in de novo analytical method development and full validation using advanced techniques like NMR, HPLC, UPLC, LC-MS/MS, GCMS, and HRMS to establish methods suitable for cGMP-compliant release testing and stability studies.

Acceptance criteria for custom methods are scientifically derived, pre-defined, and fully validated according to ICH Q2(R2) guidelines. The criteria are set collaboratively: the client defines the required product specifications, and Emery Pharma's scientists develop a Validation Protocol that proposes specific, stringent acceptance criteria for each required validation parameter, such as Accuracy, Precision, and Linearity. The client must formally approve this protocol before validation begins, ensuring the method is fit for its intended use.

Data integrity is maintained through cGMP compliance, including 21 CFR Part 11-compliant electronic records, secure data audit trails, independent peer review of all data, and clear traceability from the sample receipt to the final Certificate of Analysis (CoA).