Skip to main content

Pharmaceutical Testing

Pharmaceutical cGMP Testing for Release and Stability

USP-NF compendial and monograph testing for drug substances, excipients, and finished products with documented data integrity.

USP-NF Methods cGMP Compliant Part 11 Audit Trails Release + Stability

Common project paths

  • Raw material identity and purity confirmation
  • Finished product release and stability support
  • USP-NF monograph and general chapter testing
  • OOS, deviation, and impurity investigation support
USP-NF Compendial method alignment
cGMP Documentation and review practices
Part 11 Audit-trail-aware workflows

Standards & Certifications

USP-NF cGMP 21 CFR Part 11 ALCOA+ data integrity

Common testing needs

Typical questions teams bring to the lab.

Release testing

Assay, identity, related substances, dissolution, and content uniformity support.

Raw material qualification

API and excipient identity, purity, and monograph compliance testing.

Investigation support

OOS, impurity, degradation, and deviation support with traceable documentation.

Compliance and documentation

Documentation designed for regulated decisions.

Compendial context

USP-NF methods and acceptance criteria are treated as the controlling method reference where applicable.

Data integrity

Electronic records, review trails, and calculations are handled with ALCOA+ expectations in mind.

Audit readiness

Reports include method references, acceptance criteria, and supporting data needed for review.

Product and sample examples

Representative material types we routinely scope.

APIs

Drug substances, reference materials, and impurity standards.

Excipients

Raw materials and compendial excipient samples.

Finished products

Tablets, capsules, liquids, and stability samples.

Ready to scope pharmaceutical testing?

Tell us the monograph, material type, and deadline. We will confirm method fit and turnaround.

Request Analysis