WHO PUBLIC INSPECTION REPORT (WHOPIR) - Active Pharmaceutical Ingredient (API) Manufacturer - Anhui Biochem United Pharmaceutical Co., Ltd - Part 1 General Information - 19-22 January 2016

Sep 13, 2026

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WHO Prequalification Public Inspection Report (WHOPIR) documents the 19–22 January 2016 routine GMP inspection (new site) of Anhui Biochem United Pharmaceutical Co., Ltd in Anhui, China. The report records site details, facilities, staffing levels, and the scope covering production and quality control activities for zidovudine and lamivudine APIs. It summarizes manufacturing lines, stored materials and utilities, and identifies the relevant inspected areas including documentation, validation, change control, laboratory controls, storage and distribution, and complaints and recalls.

LanguageEnglish

CategoryPaper Templates

FormatPDF

Pages14

Reading Time5 min

AccessFree to download

PART 1: GENERAL INFORMATION

PART 2: General information about the company and site

History of WHO and/or regulatory agency inspections

Focus of the inspection

Inspected Areas

PART 3: INSPECTION OUTCOME

3.1 QUALITY MANAGEMENT (QM)

3.2 PERSONNEL

Prequalification Team WHO PUBLIC INSPECTION REPORT (WHOPIR) Active Pharmaceutical Ingredient (API) Manufacturer PART 1: GENERAL INFORMATION | Name of Manufacturer | Anhui Biochem United Pharmaceutical Co., Ltd | | --- | --- | | Buildings | No 3 and No 5 | | Physical address | Zone B, Innovation Avenue, Taihe Industrial Park, Anhui, People’s Republic of China | | Postal address | As above | | Date of inspection | 19 – 22 January 2016 | | Type of inspection | Routine GMP inspection (new site) | | Active Pharmaceutical Ingredient(s) included in the inspection | • APIMF264 zidovudine
• APIMF265 lamivudine
used for HA656 lamivudine/zidovudine, tablet, filmcoated 150mg/300mg | | Production Lines | Chemical Synthesis | | Summary of the activities performed by the manufacturer | Production and quality control of intermediates and finished non-sterile APIs.
No toxic or hazardous substances were handled or manufactured | PART 2 General information about the company and site The Anhui Biochem United Pharmaceutical Co., Ltd manufacturing site is located at Zone B, Innovation Anenue, Taihe Industrial Park, Anhui, Peoples Republic of China. There were the following facilities in the site. • Warehouse Building for solid raw material, excipients, intermediates and API (Solid Warehouse); • Liquid Warehouse; • 5 Production Buildings in total, for producing the API products; o Lamivudine is manufactured in Building \#3 for CME synthesis and o Building \#5 for the other steps o Zidovudine is manufactured in Building \#5 ( different production line with lamivudine) • Comprehensive Building (General Office in 2nd floor, QC lab in 4th floor); • Boiler Facility; • Sewage station. The number of persons working at Anhui Biochem United Pharmaceutical was about 492 of which 302 were involved in production, 42 in quality assurance (QA) and quality control (QC) . The following APIs and their intermediates for all APIs were manufactured at the site: • Lamivudine • Ritonavir • Zidovudine • Nevirapine • Lopinavir • Lafutidine • Entecavir • Tenofovir disoproxil fumarate • Emtricitabine • Efavirenz History of WHO and/or regulatory agency inspections The site was not previously inspected by a WHO Prequalification team. The site has been inspected by the following authorities: • China Food and Drug Administration (CFDA) • Brazil National Health Surveillance Agency (ANVISA) Focus of the inspection The inspection focused on the production and quality control operations related to the zidovudine and lamivudine APIs. Inspected Areas • Quality Management • Personnel • Buildings and facilities • Process equipment • Documentation and records • Materials management • Production and in-process controls • Storage and distribution • Laboratory controls • Validation • Change control • Rejection and reuse of materials • Complaints and recalls • Contract manufacturers (including laboratories) PART 3: INSPECTION OUTCOME 3.1 QUALITY MANAGEMENT (QM) Principles The current organizational chart was reviewed. Quality manager was also the qualified person (QP), reporting directly to the president & general manager. Quality Unit was independent of Production Unit. QP, production manager and QA manager job responsibilities were reviewed. In general responsibilities were in line with GMP requirements. According to the QA manager job description he was deputizing QP in his absence. Management review (MR) The SOP “Management review (MR)” was discussed. This was the first version of the SOP, therefore till the date of the inspection management review was not carried out. According to the SOP MR should be carried out at least annually, quality department should report to the management at least every 3 months. The company claimed that the first MR will be carried in March 2016. Internal audits (self-inspection) The SOP “Self inspection” and flow chart were discuss

FAQs

Which API production and quality control operations were the inspection focused on?

The inspection focused on production and quality control operations related to the zidovudine and lamivudine APIs.

What type of inspection was conducted and when?

It was a routine GMP inspection (new site) conducted from 19 to 22 January 2016.

Was the site previously inspected by a WHO Prequalification team?

No, the site was not previously inspected by a WHO Prequalification team.

Sep 13, 2026

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