PHDS in the CFDA on-site GMP Inspection

PHDS is a leading service provider of GMP audits for manufacturers of excipients (excipient audit), active substances (API audit) and finished medicinal products. On behalf of our customers worldwide, PHDS’ auditors verify whether suppliers work in accordance with the principles of Good Manufacturing Practice (GMP).

PHDS audits compliance with the GMP guidelines for medicinal products; PHDS’ GMP audits follow a systematic process to create audit trails and their objective assessment. This allows for adequate and risk-based auditing of system-specific and product-specific aspects. PHDS’ auditors have versatile hands-on professional experience in auditing, for instance of active ingredients and excipients, packaging as well as of final medical products. Hence, they contribute a transdisciplinary dimension to GMP audits. 

Since 2011, the CFDA has launched the on-site inspection on overseas pharmaceutical firm in accordance with the national GMP standard of China. Relying on the result of which, the CFDA will decide whether permit importation (Drug License Application) assuring the medication safety. PHDS helps our clients on the correction and improvement of both the facility and quality management system in accordance with the submitted application documentation, updated GMP regulation, and other applicable requirements/guidelines. PHDS is your strong support in preparation of NMPA’s on-site inspection.

What we do:

1.   Offering guidance regarding China’s updated GMP certification

2.   Comparison between EU/US GMP, solution provided

3.   SMF(Site Master File) or PMF(Plant Master File) preparation guidance

4.   QM system audits

5.   GAP analysis/identifying defects

6.   Onsite training