Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs.
To register a drug in China, the drug factory must meet China’s GMP standards. China initiated GMP requirements for drugs in 1988 but has revised these requirements several times with the latest update going into effect on January 17, 2011 (The 2010 Revision). The updated GMP guideline consists of 14 chapters including updates on the quality control system, which now includes the full process of drug design, testing, production, storage, distribution, and R&D. ICH regulations Q9 and Q10 were implemented to lower risk and guarantee quality. This updated GMP guideline will help China drug companies improve drug manufacturing standards.
Pacific Bridge Medical does quality drug GMP audits in China. Below is a sample China GMP audit plan that we will do on a two-day audit. Of course, for larger drug factories, we have spent as many as five days doing the initial on-site audit and many more days doing remediation.
Draft Audit Plan
- Background information
At this time, work thus far has been early phase development work. Factory 1 will be making XYZ-1, a precursor to XYZ-2, and potential future Regulatory Starting Materials. The first batch of XYZ-1 that will be used for GMP production of XYZ-3 is scheduled to be completed before the end of the 2nd quarter.
The plan is to perform a comprehensive Quality Systems audit prior to manufacture/release of GMP material. The Quality Agreement is in DRAFT and will be finalized soon, absolutely prior to the audit.
- Audit Purpose
The purpose of the audit is to evaluate the level of cGMP compliance of Factory 1 and Factory 2 plants as suppliers of Products for the Client.
- Audit Scope
The audit will focus on all the Quality systems, Facilities and Equipment, Material Control, Production, Packaging and Labelling, and Laboratory control systems that are directly or indirectly involved in the manufacture of API.
- Regulations
The audit will use as a reference the following regulations/guidance:
Applicable ICH: ICH Q7 and Q8
Guidelines: WHO GMP guideline
- Audit Agenda
A proposal for the audit agenda is outlined below. The audit agenda will be confirmed during the opening meeting:
- Documentation
Upon our arrival at the plant, we kindly ask you to provide us with copies of available certificates (e.g., GMP Certificate, CEP Certificate, ISO 9001, if applicable).
Furthermore, as applicable, we need to review the following documents during the audit:
- Master files and Plan
Site Master File and Quality Manual Validation Master Plan
Validation/Qualification Schedule Internal Audit Plan
Training Matrix and GMP Annual Training Plan Preventive Maintenance Plan
Calibration Plan
- Chart
Current Organizational Chart/Responsibilities and Quality System Organizational Chart Facility Layouts
Utilities Layouts
Areas Zoning Layouts
- List
SOPs list
List of Process Equipment, Laboratory Equipment and Utilities List of Computerized Systems
Supplier list (together with the qualification dossier), relevant Quality agreement with the
supplier
List of change for concerned products in last 2 years
List of deviations for concerned products in last 2 years List of OOS for concerned products in last 2 years
List of complaints for concerned products in last 2 years List of returns for concerned products in last 2 years
List of reprocesses and reworks for concerned products
The records for the above list.
- SOP
Deviation management Change Control
OOS/OOT
Complaints management CAPA management
Quality risk management Return management
Rework/reprocessing SOP Pest control SOP
Cleaning validation program Stability program
Concerned products process procedure
Water systems monitoring procedure and trending
Environmental monitoring procedures and trending for concerned production areas Other SOP upon request
- Report and record
Master Production and Control Records for concerned products Executed Batch Records for concerned products
Product Annual Quality Review for concerned products
Periodical re-Qualifications Protocol and Report of the involved equipment
Method Validation Protocol and Reports (method transfer document if applicable) Critical persons’ training record
- Other documents as requested
- Reporting
A report will be provided to the Client 3 weeks after the completion of the audit.
- Confidentiality
All information and documents received will be treated confidentially.
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:http://english.nmpa.gov.cn/2019-07/25/c_390613.htm