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Attendees did get free access to a Labcompliance website with lot's of reference material. The material will help to easily implement what they have leaned during the workshop.

With master plans checklists, examples,  SOPs, and FDA presentations for easy implementation










1) HPLC Testing (OQ, System suitability)

2) Update on Part 11

3) Risk based computer system validation

The workshop includes links to FDA and international regulations and guidelines


GMP Compliance Workshop at Peking University with Dr. Ludwig Huber

Equipment Qualification and System Validation in Laboratories

December 1/2, 2007                                               Photos

Graduate Program of International Pharmaceutical Engineering Management

The workshop was part of the Graduate Program of International Pharmaceutical Engineering Management at Peking University. The program is dedicated to quality management and regulatory science and provides an excellent opportunity to middle and senior management of pharmaceutical companies and government regulatory agencies. The objective is to produce highly trained professionals meeting international standard for the pharmaceutical industry and regulatory agencies of China.  The program is supported by the US FDA, the Chinese SFDA, and world leading Pharmaceutical companies. The workshop was sponsored by Agilent Technologies. So far there were eight classes from the start of the graduate program, and judging from the feedbacks of the audience this workshop was most welcome.

Workshop objectives

  • Get a thorough understanding of FDA and international drug regulations and guidelines
  • Systematically learn how to effectively implement and apply lab-equipment and computer system validation for day/-by-day lab operations
  • Understand consequences of non-compliance
  • Prepare your lab and organization for successful FDA and international GMP inspections
  • Generate, maintain and archive analytical test results with highest accuracy, reliability and data integrity

Contents Overview

  • FDA regulations and guidelines
  • FDA inspection and enforcement practices
  • Developing a laboratory compliance master plan
  • Sampling: sampling plan, representative sampling, documentation
  • Sample handling: preventing deterioration and loss or damage
  • Qualification of analytical equipment and computers
  • Quality management of qualification of chemicals
  • Validation of analytical methods and procedures
  • Stability testing: when and how
  • Developing an FDA compliant training plan
  • Writing FDA compliant procedures
  • Managing failure investigations and OOS results
  • Maintenance and archiving of paper and e-records
  • Preparation for FDA inspections
  • Most frequently cited deviations. Recommendations on how to avoid them.

Detailed Agenda Day 1:

Requirements and approaches for Equipment Qualification

  •   Validation overview: equipment, computers, methods, system suitability testing
  • FDA/EU requirements, expectations and enforcement
  • USP Chapter <1058> : Analytical Instrument Qualification
  • USP and EP requirements for system suitability testing
  • Learning from the GAMP Good Practices guide for Laboratory System Validation
  • The equipment qualification lifecycle

Going through the qualification phases

  • Validation planning
  •  Design qualification, specifications, vendor assessment
  • Installation and operational qualification
  • Performance qualification
  • System suitability testing: frequency, tests, acceptance criteria
  • Maintenance, change control and updates

Equipment Qualification and Maintenance

  • FDA requirements
  • USP chapter <1058> for analytical instrument qualification
  • The equipment qualification life-cycle: 4Q model
  • Qualification steps: DQ, IQ, OQ, PQ
  • Managing and recoding changes
  • Equipment maintenance program
  • Documentation

Requalification - who, what, when, how much

  • At regular intervals
  • After hardware and firmware upgrades
  • After moving the instruments
  • When the equipment is used for other applications
  • Before/after maintenance
  • Who does it: vendor or user?

Going from simple to more complex examples

  • Glassware - do we need any formal qualification?
  • Balances, pH meter
  • Ovens, refrigerator
  • UV Spectrophotometer
  • GC, GC/headspace, MS

Vendor Contributions for Equipment Qualification

  •  Helping to select the right equipment and specifications
  • Development and manufacturing in a quality environment
  • Preventive maintenance to ensure on-going performance
  • Assistance for on-site qualification: IQ and OQ
  • Software for system suitability testing

Detailed Agenda Day 2:
Practical Computer System Validation and Part 11 Compliance

Cost Effective Computer System Validation:

  • FDA/EU expectations and enforcement
  • • Recent warning letters and how to avoid them
  •  International requirements: Europe, Japan, Australia, Singapore
  •  Recommendations from Industry task forces, e.g., GAMP
  • Developing an effective computer system validation program
  • What’s important for planning, specifications, IQ/OQ/PQ, changes
  • Review and revalidation: when, what, how

Validating special systems and applications

  • Excel spreadsheets
  • Network infrastructure
  • Networked data systems
  • Enterprise content management systems

Risk based validation: optimizing your resources

  • Risk management approaches
  • Defining risk categories for laboratory systems
  • Defining validation tasks for high/medium/low risk systems
  • ‘justify and document’ your decision
  • Going through examples

Compliance with e-records/signature regulations

  • How to comply FDA’s Part 11: now and in future
  • Which systems need to comply with Part 11
  • How to control and record access to computer systems and data
  • How to sign records electronically
  • How to define and maintain raw data
  • How to archive data: paper vs. electronic data
  • FDA’s biggest concern: integrity of electronic data – the problem and solutions

Vendor Contributions for Computer Validation and Part 11 Compliance

  • Helping to select the right system and specifications
  • Validation during development
  • Software functionality: limited access, electronic audit trail, electronic signatures
  • Solutions for long term archiving and retrieval
  • Assistance for on-site validation
  • Practical demonstration of compliance functionality (DQ, IQ, OQ, PQ)

Collaborative Exercises, Discussions and Examples

Practical examples, case studies and collaborative exercises where dispersed into and between the presentations. At least 50% have been dedicated to practical sessions and discussions with life examples. The outcome will be made available for all attendees on a special workshop reference website. Practical sessions include:

  1. Requirements for equipment hardware vendors
  2.   User requirements for an HPLC system
  3. OQ testing for HPLCs
  4. PQ testing for HPLC
  5. HPLC requalification
  6. Documentation of HPLC system qualification
  7. Corrective actions to 10 FDA warning letters
  8. Requirements for suppliers of chromatographic data systems (CDS)
  9.  User requirements for a CDS
  10. OQ testing for CDS
  11. Requalification after computer system changes
  12. HPLC system for API quality control: Part 11 requirements
  13. Using Excel for training records
  14. Automated IR analysis
  15. Paper scanning for electronic archiving
  16. Using Excel templates as sophisticated calculator

10+ Reference documents for easy Implementation

Reference documents have been made available on a special workshop reference website. The site is password protected and is available until end of December 2007. .
They include

  • SOPs:
    - Change Control for Analytical Equipment
    - Maintenance of Equipment
    - Development and Maintenance of Test Scripts
    - Change Control of Software and Computer Systems
    - Configuration Management and Version Control of Software
    - Risk assessment for Laboratory Systems
    - Validation of Laboratory Computer Systems
    - Validation of COTS Computer Systems
    - Verification of Compendial Methods
    - Risk Based Validation of Computer Systems
    - Validation of Spreadsheet Applications
  • Master Plans
    - Equipment Validation
    - Validation o Computer Systems
  • Worksheets/Checklists/Examples
    - IVT Standard: Qualification of Network Infrastructure
    - Validation of Chromatographic Data Systems
    - Qualification of HPLC Systems
  • FDA Presentations and Reports
    - Risk Based Validation of Computer Systems
    - Update on Part 11
    - HPLC Testing (OQ/PQ)
  • Warning letters and/or Inspectional observations related to Analytical Laboratories

The seminar has been attended by 70 professionals

Middle and upper management including:

  • Directors
  • QA managers
  • Lab managers
  • IT managers
  • Regulatory affairs

About the speaker: Dr. Ludwig Huber

  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
  • Presenter of the Year of the Institute for Validation and Technology
    Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • For more information on Ludwig Huber, click here.


Group photo with attendees and officials in front of the Peking University

Selected photos with annotations 

The master program has been launched in April 2007 by FDA's Joseph Famulare, deputy director of the office of compliance (in the middle). Others on the podium (from left):
Robert Horan, Eric Henrikson, Nick Buhay, all FDA, and Ludwig Huber (right)
The workshop room room was fully packed with 70+ professionals, right from the beginning. Attendees were managers from industry and officials from SFDA.
The workshop was sponsored by Agilent Technologies.
Agilent offers a wide rage of instrument hardware, software, consumables and services that help the industry with compliance and to increase productivity
Ludwig Huber started with basics of equipment qualification. He then explained the approach of USP <1058> for analytical instrument qualification.
Attendees could practices what they had learned in workshop type exercises.
Ludwig Huber helping students to complete workshop tasks.
The audience presented results of workshop tasks. They have been discussed with the entire audience.
Questions from the audience came in directly either in Chinese or English. They came in in writing or verbally.
Zhi-xu Zhang, applications engineer manager of Agilent Technologies was a great help in translation and answering questions
Students used the tea breaks to answer more questions for clarification.
At the end of day one a typical chinese buffet dinner was ready for students, officials and presenters at the the universities Shao Yuan Restaurant. 
Even during the diner, students came with more questions.
Not only technical information but also information on each others countries has been exchanged.
Ludwig Huber with Chen-jie Zhuang, China's pharmaceutical industry manager of Agilent Technologies and Dr. Quiang Zheng, who is responsible for the University's  master program
Photo at the end of day one after most students had already left.
  Ludwig discusses his new video with Ms. Mona Zhang, Deptm. Head at SFDA Shanghai 
Zhi-xu Zhang of Agilent presented case studies on how Agilent's Open Lab can help with compliance and improve efficiency in laboratories.
Towards the end Ludwig Huber answered all remaining questions. And there were many.
Ludwig Huber asks the last time if there is any open question.
Finally Ludwig Huber thanked the audience for great interaction.
Ludwig Huber receiving a gift from the Peking University through Dr. Quiang Zheng.

More and larger photos going through the workshop from beginning to the end