The CFDI GMP Inspection Consulting Service of Drugs/Medical Devices

Background Introduction

As the implementation of the 2010’s version GMP in China, CENTER FOR FOOD AND DRUG INSPECTION OF NMPA (CFDI) strengthens the overseas GMP inspection on imported drugs and medical devices. Since 2011, every year dozens of overseas pharmaceutical/medical devices companies had been audited by CFDI. There are many companies among them failing to pass the CFDI inspection because they are not adept at Chinese GMP, and finally lost Chinese market.

In order to help these pharmaceutical/medical devices companies understand Chinese GMP, fill the gap with Chinese regulatory requirements, and successfully pass the GMP inspection of CFDI, our company launched the service of providing GMP consulting for overseas pharmaceutical/medical devices companies.


CANNY’s Introduction

Founded in 1998, Beijing CANNY Consulting INC. has been focusing on GMP compliance consultation and registration consultation of health products in 22 years, helping more than 600 companies to improve the level of GMP or provide registration agency services, and hence the service quality has been praised by the industry. From 2011, CANNY began to provide drug registration and overseas GMP inspection consulting services for overseas pharmaceutical/medical devices companies, providing strong supports for these companies to successfully entry into China.


Services Introduction

In the CFDI overseas GMP inspection services of pharmaceutical/medical devices, we provide the services as below.

Number

Service Name

Service Items

1.             

Overall GMP Gap Analysis

- Evaluate the gap compared to Chinese GMP requirements

- Evaluate manufacturing process consistency

2.             

Mock Audit

- Simulate CFDI inspection process and characteristics to inspect the pharmaceutical/drug   devices companies

- Training GMP Translators

3.             

Supports during official inspection

- Pre-training before CFDI official inspection

- Arrange the workflow and the venue before the inspection

- GMP technical support during the inspection

- Provide professional GMP translation service during the inspection

- Non-technical   support before and after the inspection, such as shuttle the inspectors

4.             

Training  

- Chinese GMP Training

- Chinese Pharmacopeia Training

- Chinese Culture Training

- Official Inspection Preparation and Skills Training

- CAPA report training

5.             

On-site GMP Translation

- Provide professional GMP translation service during the inspection, including oral   and written translation

- Provide audit material, audit report and CAPA report translation service

6.             

CAPA Consulting Services

- Provide CAPA methods, strategy and skills after the inspection

- Review CAPA report

- Translate CAPA report

7.             

CFDI Audit Failure Renew Service

- Clients: who have been found with critical deficiencies after official inspection or have been determined as audit failure or have been issued an import ban by CFDI

- Help companies finish CAPA and regain the qualification of importation by compliance, CAPA and consulting services

8.             

Package Service Solution

- The above services can be provided separately or together.

9.

Imported   Products registration Agency/Consulting

- Provide filing/registration agency or consulting service for overseas pharmaceutical companies (Drug products and API)


Achievements

CANNY has provided CFDI overseas GMP inspection consulting service to more than 20 overseas companies or groups, making CANNY becomes the most professional and largest consultancy for overseas companies in China. And CANNY:

  • Provided gap analysis and mock audit services for 16 overseas companies.

  • Provided training services for 18 overseas companies.

  • Provided translation services for 18 overseas companies.

  • Provided audit failure renew services for 4 overseas companies.

  • Provided imported filing/registration services for more than 100 companies’ 200+ products.

  • Part of Overseas GMP Inspection Cases


Our Advantages

CANNY has 23 years of GMP consulting experience, and CANNY is:

  • The first consultancy in China to provide GMP compliance consulting services;

  • The first consultancy in China to help overseas companies pass the NMPA inspection.


CANNY has helped our clients to successfully pass:

  • NMPA certification over 400 cases;

  • US-FDA inspection over 50 cases (10 of them are zero-deficiency);

  • National Authorities of the European Union and EDQM inspection over 50 cases;

  • TGA inspection over 10 cases.