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Third-party GMP Auditing

GMP Audits for API/Dosage Form

The independent third-party GMP audit service provided by BBC is to evaluate GMP compliance status of the manufacturer
in accordance with the current GMP requirements set forth in 21 CFR Part 210 & 211 with its interpretations.
The compliance status will be evaluated in terms of hardware, software, and personnel. All deficiencies identified during
the GMP audits will be noted in the audit report with gap analysis and proposed corrective actions.

The GMP audits for API/dosage form will be conducted by two BBC auditors for three days. A GMP audit report of
Chinese or English version or of both Chinese and English version will be provided.

Remedial actions should be taken to rectify these deficiencies indicated in BBC’s GMP audit report.
You can formulate your own remedial action plan or retain BBC as GMP consultant to assist you in the project to improve your GMP compliance status.

QSR/GMP Audits for Medical Device

The independent third-party QSRGMP audit service provided by BBC is to evaluate GMP compliance status of the manufacturer
in accordance with the current GMP requirements set forth in 21 CFR Part 820 with its interpretations.
The compliance status will be evaluated in terms of hardware, software, and personnel. All deficiencies identified during
the QSR/GMP audits will be noted in the audit report with gap analysis and proposed corrective actions.

The QSR/GMP audits for medical device will be conducted by two BBC auditors for three days. A QSR/GMP audit report of
Chinese or English version or of both Chinese and English version will be provided.

Remedial actions should be taken to rectify these deficiencies indicated in BBC’s QSR/GMP audit report. You can formulate
your own remedial action plan or retain BBC as QSR/GMP consultant to assist you in the project
to improve your QSR/GMP compliance status.