Aseptic Manufacturing Operation: Chinese Company Zhuhai United Laboratories does not comply with EU GMP


While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.

While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are again in the spot light. Just recently the EU found serious GMP deviations at an API manufacturer (Huzhou Sunflower Pharmaceuticals) and on 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories Co., LTD located at Sanzao Science &Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong, 519040, China into EudraGMDP.

According to the report issued by the EU GMP Inspectors, Zhuhai United was not “operating its aseptic manufacture operations in compliance with EU GMP Annex 1. This was evident from the high number of observations regarding the aseptic manufacturing facilities design, equipment, operations, environment monitoring and media fill validation”. The internal quality system of the company did not detect the problems. As a consequence the GMP non-compliance report was issued in the EU database. Companies purchasing from Zhuhai United must change the API supplier. The CEP has been suspended.

However, the case also reveals a serious problem for patients in Europe. Due to the move of manufacturing sites mainly to Asia alternative sources may not always exist. In this specific case the EU GMP certificate was withdrawn by the GMP Inspectors but will be reissued to include only non-sterile products. A restricted GMP Certificate will be issued for sterile critical medicinal products for Romania, France, and UK.

Stakeholders in industry, authorities and in government in the EU need to discuss the problems caused by outsourcing and to the fact that products will sometimes only be manufactured by single sources in the necessary quantity. Once these suppliers do not comply with GMP, products are no available any longer, or by exceptions these non GMP compliant products may still be used in order to treat patients with medicines they urgently need. Both options are not acceptable from a patient point of view.

Map of Zhuhai United Laboratories Co.,Ltd.

  1. Zhuhai United Laboratories Co.,Ltd.

  2. Pharmaceutical Company
  3. Address: Yulin Rd, Jinwan, Zhuhai, Guangdong, China
  4. Phone:+86 756 776 6777

Yulin Rd, Jinwan, Zhuhai, Guangdong, China

Zhuhai Airport

Sun Kim ……Quality-by-Design Evangelist

Sun Kim

Sun Kim – Quality by Design for Pharma, Biotech, Medical Devices

Dr. Sun K. Kim is a Quality-by-Design Evangelist, transforming how Product Development is executed in the Biologics, Pharmaceutical and Medical Devices industry. In addition, he teaches at Keio University and Stanford University. His current focus of research is Quality-by-Design, Agile Development of Drugs and Therapeutics.

He received his MS and PHD in Mechanical Engineering at Stanford University. Sun was recently a Professor at Keio University in Japan. Prior to Silicon Valley days, he served in the Korean Army and worked at BMW in Munich, Germany

Sun Kim


Quality by Design – Founder


January 2013 – Present (2 years 6 months)

Founder of

Quality by Design for Biotech, Pharmaceutical and Medical Devices – Quality by Design Tools and Case Studies


Stanford University

2005 – Present (10 years)Stanford, CA

Teach Design for Manufacturing, Robust Design, Design of Experiments

Master Black Belt in Quality-by-Design, Lean Six Sigma, Sr. Manager

Bayer HealthCare

November 2012 – May 2015 (2 years 7 months)Berkeley, CA

Sr. Manager, Master Black Belt in Quality-by-Design, Design for Lean Six Sigma,
Leading Business Process Management

Design for Excellence Evangelist


March 2011 – November 2012 (1 year 9 months)

Master Black Belt (Lean Six Sigma), Project Management Professional, Scrum Master

Assistant Professor of Graduate School of Systems Design and Management Assistant

Keio University

March 2008 – March 2011 (3 years 1 month)

Lecture and advise graduate-level, professional students on system and product design, design thinking, creative brainstorming methodologies, prototyping, project management and business development. Solicited 15 industry project partners. Generated $35,000/year after developing non-degree curriculum for professionals. Co-Investigator of research projects of $50,000: Indoor Location-based Services Technology for Mobile Devices. Consults manufacturing companies (Hitachi, Toshiba) on growth strategies for Service Business Innovation. Others include developing cost simulation tool of product design based on injection molding, design for manufacturing and healthcare delivery systems. Began as a lecturer in Feb. 2008 to co-develop a project-based design curriculum, Active Learning Program Sequence (ALPS), educating over 100 graduate students every year.

Invited as an Assistant Professor in June, 2009.

Research, Teaching Assistant

Stanford University

September 2005 – June 2009 (3 years 10 months)

Lectured, coached and managed over 40 multi-disciplinary teams on Design for Manufacturing projects from Biomedical device (Medtronic, Maquet, St. Jude Medical, etc.) and automotive companies (Toyota, Nissan, GM, etc.). Served as the main research associate of Toshiba Corporation Six-Sigma Consulting Inc., developing systems design and manufacturing programs for Toshiba employees. Innovative projects were mobile personal-assistant IT system and agile transportation infrastructure.

Industry-sponsored Projects

Stanford University

September 2004 – June 2009 (4 years 10 months)

Maquet Cardiovascular: Coached and led a 3 member team in redesigning the crimping process of Hemashield Grafts, resulting in cost reduction of $75,000 and operators’ medical costs from injuries.

Satiety (Bariatric Surgery Device for Obesity Treatment) Design for Manufacturing Project: Coached a 3 member team in redesigning the packaging and supply chain for the Toga System, resulting in supply chain efficiency of 50% improvement by applying Lean and Errorproofing (Poka Yoke) Techniques.

Medtronic Vascular: Coached a 4 member team in redesigning the manufacturing line of a stent-graft, resulting in 73% reduction of lead time and increase in reliabilty and performance. Observed over 5 vascular and general surgery cases.

St. Jude Medical: Led a 4 member team in developing a 7-year supply chain strategy for new service centers of ICD/pacemaker programmers in Europe, Asia, N. and S. America and Oceania. The recommendation consists of an optimized cost model from net present value analysis and AHP location decision modeling that will save $461 million over 7 years and increase customer service rate compared to the existing service centers.

Nissan Motors: Led a 4 member team to construct a 20 year technology / business roadmap of Nissan Fuel Cell powertrain / vehicles which projects $ 4.8 billion revenue. Created a fuel cell vehicle concept design by applying Design for manufacturing tools including market research, manufacturability, and profitability analysis.

Zimmer Orthopedics: Implemented, with five team members, a FEA (finite element analysis) simulation tool with ABAQUS which assists in the development of treating knee osteoarthritis, based on MRI and gait data.

General Motors: Achieved potential cost reduction of $450 per vehicle and reduced 50kg of car weight by replacing wires with conductive coatings and RFID applications with a team of four members.

Design for Six Sigma Research Fellow


September 2005 – March 2009 (3 years 7 months)

Developed Design for Six Sigma Curriculum for Toshiba Corp.
Trained engineers, managers in systems design methodologies.
Coached Six Sigma projects.

Medical Device Design Innovation Program Developer

Johnson & Johnson

July 2007 – September 2007 (3 months)

Developed an innovation-incubation program to design/develop next generation product/technology with physicians and multidisciplinary design teams.

Design, Manufacturing Consultant

NeoGuide Systems

April 2006 – September 2006 (6 months)

Performed Robust Design, Design of Experiment, Developed manufacturing tooling, testing protocols and automated stations.

Reliability Research Assistant

Stanford Linear Accelerator Center

June 2005 – December 2005 (7 months)

Developed a reliability decision analysis tool for the LINAC System which will save $83 million per year on the $8 billion International Linear Collider Project. Enhanced reliability of the Accelerator system up to 20% and had increased throughput by linking Failure Mode and Effect Analysis of the Tuner to the evaluation tool.

Optimization/ Structural Analysis Intern

Samsung Electronics

February 2004 – February 2004 (1 month)

Improved impact-worthiness (20%) by optimizing design parameters of cell phone cases after performing structural analysis.

Design, Manufacturing Engineer


June 2003 – January 2004 (8 months)

Applied for 1 patent individually and created 3 design proposals as a team in 3 months. Saved $2,760 per month by implementing knowledge database management system. Resolved 3 process problems during 2 weeks of manufacturing
rotation program in Munich assembly plant with the manufacturing engineers.

US – ROK Army Radiology Tech, Company Leader, Manager

Republic of Korea Army

February 2000 – April 2002 (2 years 3 months)

Served 20,000 US Army patients as a Radiology Technician, tasks including diagnostic x-ray imaging, upper GI, etc. Managed 12 multi-national soldiers and a radiology department. Was awarded as “the accident-free company.” Increased the availability of the radiology department, which takes care of 20,000 patients, up to 130% by building a forecast schedule planning system.



Stanford University

Stanford University

Ph.D, Mechanical Engineering

2006 – 2009

Focus in Systems (Product, Service, Business) Design, Design Thinking, Design for Manufacturing and Six Sigma

Activities and Societies: Design SocietyASMEIEEEINCOSEACM

Stanford University

Stanford University

MS, Mechanical Engineering

2004 – 2006

Focus in Biomedical Device Design, Reliability Engineering, Operations Research

Activities and Societies: KOSEF Academic Fellow


A New Project-Based Curriculum of Design Thinking with Systems Engineering Techniques

International Journal of System of Systems Engineering


Agile Project Management for Root Cause Analysis Projects

International Conference on Engineering Design


A New Project-Based Curriculum of Design Thinking with Systems Engineering Techniques

Council of Engineering Systems Universities


Evaluation of Design for Service Innovation Curriculum: Validation Framework and Preliminary Results

nternational Journal of Services Technology and Management


A Validation Regarding Effectiveness of Scenario Graph

ASME International Design Engineering Technical Conferences


Wants Chain Analysis: Human-centered Method for Analyzing and Designing Social Systems

International Conference on Engineering Design


Scenario-based Amorphous Design (SAD) Framework for a Location-based Services Technology

Mobile Human Computer Interaction


Transforming Seamless Positioning Technology into a Business using a Systems Design Approach—Scenario-based Amorphous Design

IEEE- International Systems Conference


Design for Service Innovation: A Methodology for Designing Service as a Business for Manufacturing Companies

International Journal of Services Technology and Management


Preliminary Validation of Scenario-based Design for Amorphous Systems

International Conference on Systems Engineering


Tools for Project-based Active Learning of Amorphous Systems Design: Scenario Prototyping and Cross Team Peer Evaluation

ASME International Design Engineering Technical Conferences


Active Learning Project Sequence: Capstone Experience for Multi-disciplinary System Design and Management Education

International Conference on Engineering Design


Demystifying Ambiguity in The Design of Amorphous Systems

International Conference on Systems Engineering


Scenario-based Design for Amorphous Systems

ASME International Mechanical Engineering Congress and Exposition


Analysis and Design Methodology for Recognizing Opportunities and Difficulties for Product-based Services

Information Processing Society of Japan (IPSJ) Journal


Scenario Graph: Discovering new business opportunities and Failure Modes,”

ASME International Design Engineering Technical Conferences


Analysis and Design Methodology for Product-based Services

Annual Conference of the Japanese Society for Artificial Intelligence


Analysis and Design Methodology for Recognizing Opportunities and Difficulties for Product-based Services



Sun Kim

About QbDWorks…

Are you a Scientist in the Pharmaceutical, Biopharmaceutical or Medical Devices industries?

Then you are probably asking:

  • Does Quality-by-Design actually work?
  • Or is it just another program like Lean or Six Sigma?
  • How do I implement QbD successfully?
  • How do I persuade my management?
  • What is the first step?

As a QbD practitioner, I had the same questions and am trying to answer them as I test different elements of QbD.

Through our members’ successes and failures in QbD, you can save time by not having to repeat them yourself. There are many lessons learned and knowledge that you can share with your QbD team.

Who are You?

Sun Kim

My name is Sun Kim. I currently practice Quality-by-Design, transforming how Product Development is executed in Biopharmaceutical, Pharmaceutical, Biologics, and Medical Device industries.

In addition, I teach at Stanford University. My focus of research is Lean Quality by Design.

I received my MS and PHD in Mechanical Engineering at Stanford University and was recently an Asst.  Professor at Keio University in Japan. Prior to Silicon Valley days, I served in the Korean Army and worked at BMW AG in Munich, Germany, where my lifelong pursuit of “Product Development Methodology” began.

Why is an Engineer working in the Bio/pharmaceutical Industry?

Thanks for asking! When working at BMW, as a member of the elite “KREATIV” (Creative) team, my goal was to develop the best technologies and products for the automotive industry. However our approach was somewhat adhoc and heuristics-based. I knew there was a better way.

So I set my heart to learn how best products are developed across all industries. This led me to my PhD research at Stanford University.

Little did I know this would turn out to be more than just a graduate program. On top of the typical coursework, research and publishing, my schedule was packed with hands-on consulting/research projects with GE Healthcare, GE Aviations, Toyota, Nissan, Toshiba, Medtronic, Johnson & Johnson, Startup’s etc.

After contributing to the product development approaches for the Academia, Fortune 500 and Startup’s, I knew my heart was always with Health Care. So I returned to the benches and trenches.

For the last 10 years, I have been working in the Biopharmaceutical, Pharmaceutical and Medical Devices Industry, to make Quality by Design a reality.

So please join me in this Quality by Design journey.

Sign up to connect to the community and receive updates.

Together, we can change how drugs and therapies are developed for our patients and families.

Let’s Connect!

If you’d like to connect, please invite me:

Previously I worked (full time or consulting) with:

Company Logos

The views expressed on this website are personal opinions and in no way reflect the position of any organization.

Map of fremont ca

Inna Ben-Anat, Global QbD Director of Teva Pharmaceuticals

Meet Inna Ben-Anat, Global QbD Director of Teva Pharmaceuticals. Inna is a key thought leader in Quality by Design for generics. Ben-Anat, InnaASSOCIATE DIRECTOR, HEAD OF QDD STRATEGY | TEVA PHARMACEUTICALSAssociate Director, Head of QbD Strategy Chemical Engineer with a degree in Quality Assurance and Reliability (Technion-Israel Institute of Technology). QbD Strategy Leader at Teva (USA). Headed the implementation of a global QbD training programme. More than 12 years of pharmaceutical development experience. Inna Ben-Anat Inna Ben-Anat is a Quality by Design (QbD) Strategy Leader in Teva Pharmaceuticals USA. In this role, Inna has implemented global QbD training program, and is supporting R&D teams in developing Quality by Design strategies, optimizing formulations and processes and assisting develop product specifications. Additionally, Inna supports Process Engineering group with process optimization during scale-up and supports Operations in identification and resolution of any technical issues. Inna has extensive expertise in process development, design of experiments for process and product optimization, and statistical data analysis, and has more than 10 years of pharmaceutical development experience. Inna received her BSc degree in Chemical Engineering and ME degree in Quality Assurance and Reliability in Engineering from Technion-Israeli Institute of Technology. Teva Pharmaceutical Industries Ltd. 5 Basel Street PO Box 3190 Petah Tiqwa , 4951033 Israel



Assc. Director, Global QbD Strategy

Teva Pharmaceuticals

May 2013 – Present (2 years 2 months)

QbD Strategy Leader

Teva Pharmaceuticals

March 2011 – Present (4 years 4 months)

Analytical R&D

TransPharma Medical

2001 – 2005 (4 years)

Employment History

  • Director, Global QbD Strategy and Product Robustness
    Teva Pharmaceutical Industries Ltd.
  • QbD Strategy Leader
    Teva Pharmaceutical Industries Ltd.
  • Analytical Research and Development Manager
    TransPharma Medical Ltd


Petah Tikva, ISRAEL

  1. Petah Tikva – Wikipedia, the free encyclopedia

    Petah Tikva (Hebrew: פֶּתַח תִּקְוָה, IPA: [ˈpetaχ tikˈva], “Opening of Hope”) known as Em HaMoshavot (“Mother of the Moshavot”), is a city in the Central …

Khayim Ozer Street, Petah Tikva, Israel

Understanding Pharmaceutical Quality by Design 2014 Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woodcock
A quality by design study applied to an industrial pharmaceutical fluid bed granulation 2012 Vera Lourenço, Dirk Lochmann, Gabriele Reich, José C. Menezesa, Thorsten Herdling, Jens Schewitz
Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space. 2012 Eon-duval A, Valax P, Solacroup T, Broly H, Gleixner R, Strat CL, Sutter J.
Instrumented roll technology for the design space development of roller compaction process 2012 Vishwas V. Nesarikar, Nipa Vatsaraj, Chandrakant Patel, William Early, Preetanshu Pandey, Omar Sprockel, Zhihui Gao, Robert Jerzewski, Ronald Miller, Michael Levin
Rapid exploration of curing process design space for production of controlled-release pellets 2012 Katja Kristan andMatej Horvat
Automating push-through force testing of blister packs 2011 Jha, Salil
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms 2011
QbD Status Update Generic Drugs 2011 Susan Rosencrance
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework 2011 Junker B, Kosinski M, Geer D, Mahajan R, Chartrain M, Meyer B, Dephillips P, Wang Y, Henrickson R, Ezis K, Waskiewicz M.
Quality by design and process analytical technology for sterile products–where are we now? 2010 Riley BS, Li X.
Development of quality-by-design analytical methods 2010 Frederick G. Vogt andAlireza S. Kord
Roadmap for implementation of quality by design (QbD) for biotechnology products. 2009 Rathore AS
Quality by Design for Biopharmaceuticals: Principles and Case Studies 2009 Anurag S. Rathore (Editor), Rohin Mhatre (Editor)
Quality by design for biopharmaceuticals 2009 Anurag S Rathore & Helen Winkle
Formulation optimization of long-acting depot injection of aripiprazole by using D-optimal mixture design 2009 Nahata T, Saini TR.
Quality by Design: Get to the production scale quickly and successfully with Design of Experiments 2009 Norbert Pöllinger, Stefanie Feiler, Philippe Solot,
Pharmaceutical quality by design: product and process development, understanding, and control. 2008 Yu LX
Quality by design for biopharmaceuticals 2009 Anurag S Rathore1 & Helen Winkle2
Why quality-by-design should be on the executive team’s agenda 2009 Ted Fuhr, Michele Holcomb, Paul Rutten
BioProcess Control: What the Next 15 Years Will Bring 2008 Michael Boudreau, Emerson Process Management, Inc. and Trish Benton, Broadley-James Corp.
QbD for Better Method Validation and Transfer 2010 Phil Nethercote, Phil Borman, Tony Bennett, GSK; Gregory Martin, Complectors Consulting LLC, and Pauline McGregor, PMcG Consulting
A Quality-by-Design Methodology for Rapid LC Method Development (Parts I, II and III) 2008 Ira Krull, Michael Swartz, Joseph Turpin, Patrick H. Lukulay, Richard Verseput;;
What Your ICH Q8 Design Space Needs: A Multivariate Predictive Distribution 2010 John J. Peterson, GlaxoSmithKline Pharmaceuticals
Quality-by-Design Using a Gaussian Mixture Density Approximation of Biological Uncertainties 2010 N. Rossner, Th. Heine, R. King
An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design 2010 Daniel M. Hallow, Boguslaw M. Mudryk, Alan D. Braem, Jose E. Tabora, Olav K. Lyngberg, James S. Bergum, Lucius T. Rossano, Srinivas Tummala
Process modeling and control in drug development and manufacturing 2010 Edited by Cynthia Oksanen and Salvador García-Muñoz
Bioprocesses: Modeling needs for process evaluation and sustainability assessment 2010 Concepción Jiménez-González, John M. Woodley
Computer-aided molecular design using the Signature molecular descriptor: Application to solvent selection 2009 Derick C. Weis , Donald P. Visco
Process modeling and optimization of batch fractional distillation to increase throughput and yield in manufacture of active pharmaceutical ingredient (API) 2010 Yubo Yang, , Rosalin Tjia
The use of modeling in spray drying of emulsions and suspensions accelerates formulation and process development 2009 James W. Ivey, Reinhard Vehring
Pharmaceutical process/equipment design methodology case study: Cyclone design to optimize spray-dried-particle collection efficiency 2010 Lisa J. Graham, Rebecca Taillon, Jim Mullina, Trevor Wigle
Practical application of roller compaction process modeling 2010 Gavin Reynolds, Rohit Ingale, Ron Roberts, Sanjeev Kothari, Bindhu Gururajan
Understanding variation in roller compaction through finite element-based process modeling 2010 John C. Cunninghama, Denita Winstead, Antonios Zavaliangos
Optimizing the design of eccentric feed hoppers for tablet presses using DEM 2010 William R. Ketterhagen, Bruno C. Hancock
Temperature and density evolution during compaction of a capsule shaped tablet 2010 Gerard R. Klinzing, Antonios Zavaliangos, John Cunningham, Tracey Mascaro, Denita Winstead
Drug product modeling predictions for scale-up of tablet film coating—A quality by design approach 2010 Andrew Prpich, Mary T. am Ende, Thomas Katzschner, Veronika Lubczyk, Holger Weyhers, Georg Bernhard
Handling uncertainty in the establishment of a design space for the manufacture of a pharmaceutical product 2010 Salvador García-Muñoz, , Stephanie Dolph, Howard W. Ward II
ICAS-PAT: A software for design, analysis and validation of PAT systems 2009 Ravendra Singh, Krist V. Gernaey, Rafiqul Gania,
An ontological knowledge-based system for the selection of process monitoring and analysis tools 2010 Ravendra Singh, Krist V. Gernaey, Rafiqul Gani
An ontological framework for automated regulatory compliance in pharmaceutical manufacturing 2009 M. Berkan Sesen, Pradeep Suresh, René Banares-Alcantara, Venkat Venkatasubramanian