Foothill Ranch, CA
ACTA offers method development, method validation, and method transfer when our clients need it for full cGMP compliance, to USP and ICH Q2(R2) requirements. Stability-indicating methods for pharmaceutical and medical device products, with a Validation Protocol written before the study and a Validation Report that meets FDA requirements.
ACTA's staff is highly experienced with method development for all dosage forms, both compendial and non-compendial, including stability-indicating methods. Our chemists develop rugged, accurate methods on the instrumentation the analysis actually calls for, then carry them through validation when you request it, so the method holds up under FDA review.
Most development work runs on HPLC and GC, with the detector matched to your compound. You receive a documented, validated procedure suitable for release testing or to support a regulatory submission.
Representative dosage forms. Tell us your material and we will confirm the development approach.
When you request cGMP method validation, ACTA performs it in accordance with USP and ICH requirements. We prepare a Validation Protocol before the study and furnish a Validation Report that meets the requirements of the FDA. The characteristics we validate follow ICH Q2(R2), the current revision, developed alongside ICH Q14 on analytical procedure development.
A method already published in the USP does not need full validation, it needs verification: confirmation that the compendial procedure performs as intended under ACTA's actual conditions of use, with your material, our analysts, and our instruments.
Verification is a focused subset of the validation characteristics, sized to the method and the risk, rather than a full revalidation. It is what the USP expects the first time an official article is tested by a compendial procedure in a new laboratory.
Method transfer qualifies a receiving laboratory to run a method that was validated somewhere else. As your receiving lab, ACTA follows the transfer approach that fits the method's complexity, the facilities involved, and your regulatory requirements.
Both laboratories test the same lot against pre-set acceptance criteria defined in a transfer protocol.
The receiving lab takes part in an inter-laboratory validation, so transfer and validation happen together.
The receiving lab performs a complete or partial validation of the method in its own hands.
A justified omission of formal transfer when the method is well established or already in use.
Prove a new or non-compendial method works, across the full set of characteristics.
New methodConfirm an existing compendial method performs in our lab, with a focused subset of checks.
USP method, new labQualify our lab to run a method that was validated somewhere else.
Moving a method between labs
Assay and impurities by HPLC with the detector matched to your compound.
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Volatiles and residual solvents by GC and GC-MS.
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cGMP storage with scheduled pull testing using stability-indicating methods.
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The compendial chapters behind validation, verification, and transfer.
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