Foreword

　　The Center for Food and Drug Inspection (CFDI) organized to conduct a total of 431 inspections throughout the year, including pre-approval inspection, GMP certification inspection, GMP follow-up inspection, unannounced inspection, overseas inspection ,GSP unannounced inspection and inspection observation.

Part I Pre-approval Inspection

　　I. Overview of Inspections

　　A total of 29 inspection tasks were received in 2016, of which 21 tasks were from the Center for Drug Evaluation of CFDA (hereinafter referred to as CDE), 8 tasks were from the Department of Drug and Cosmetics Registration of CFDA and discipline inspection and supervision departments (for-cause inspection tasks). A total of 178 person-times, 43 inspection teams have been sent out to conduct pre-approval inspection on 34 varieties; 42 on-site inspection reports have been completed, of which 34 passed the inspection, accounting for 81%; and 8 failed or proactively withdrew registration applications, accounting for 19%.

　　II. Main findings

　　In the pre-approval inspections in 2016, such problems in data integrity as untraceable data and untruthful application dossier were still prominent while insufficient process validation and instable production process and inconsistency between production process or parameters with approved ones were also identified, which were specifically as follows: (All issues found in inspection have been dealt in accordance with the law.)

(I) Problems in data integrity

1. Testing data were untraceable. A few enterprises failed to retain samples as required and conduct stability investigation. No retained preproduction samples and retained samples for stability test of the inspected varieties were found in pre-approval inspection, and enterprises also failed to provide both the requisition and destruction records of corresponding retained samples and the samples for stability test and use records of the equipment for stability test.

2. Batch production records were untruthful and incomplete and inconsistent with application dossier.

(II) The process validation was insufficient and production process was instable

The process validation for the variety was insufficient. During the dynamic production of the enterprises, some procedure had serious deviation or batch product yield had a greater deviation from the validated batch.

(III) The production process or key process parameters and inner packaging materials were inconsistent with the approved ones and no study and assessment was conducted

1. The production process was inconsistent with that approved / under application.

2. Key process parameters were inconsistent with the production process approved / under application.

3. The manufacturer of inner packing materials was inconsistent with that under registration application, and the enterprise did not conduct comparison study.

(IV) Necessary deviation investigation was not conducted

There was significant abnormality in dynamic production, but the investigation was insufficient and the primary cause was not identified. The results of the process validation of three batches and dynamic production batch of the chemical APIs under application by an enterprise showed that there was significant difference in the rate of finished products among four batches, but the enterprise did not analyze and identify the reasons.

Part II Pharmaceutical GMP Certification Inspection

　　I. Overview of Inspections

　　Based on the spirit in the Announcement of China Food and Drug Administration on Relevant Issues of Halting the Production by the Enterprises Failing to Pass the Pharmaceutical GMP (revised in 2010) Certification and Decentralizing the Certification of Sterile Pharmaceuticals (2015 No.285), China Food and Drug Administration no longer accepted the application for pharmaceutical GMP certification as of January 1st, 2016. For the certification applications that have been accepted, on-site inspection as well as review and certificate-issuing continued to be completed.

In view of above situation, the inspections on 16 pharmaceutical manufacturers have been arranged, 16 copies of on-site inspection reports have been received and 14 copies have been reviewed throughout the year of 2016. Among them, 12 pharmaceutical manufacturers passed pharmaceutical GMP certification inspection, 2 pharmaceutical manufacturers failed to pass pharmaceutical GMP certification inspection and 5 pharmaceutical manufacturers were issued with Warning Letter; and another two pharmaceutical manufacturers have not yet received approval document for registration so the GMP certification process is suspended.

The dosage forms under application for certification included large volume injection of three enterprises, small volume injection of three enterprises, c of three enterprises, powder injection of one enterprise, radiopharmaceutical of one enterprise, vaccine of two enterprises and other biologics of three enterprises.