GMP Audit and ICH Q11 – API Manufacturing Workshop

2-Day In-Person Seminar (Code – INDSEM129)

GMP Audit and ICH Q11 – API Manufacturing Workshop

    Ahmedabad, GJ, India


    July 25 – 26, 2019

Seminar DescriptionAgendaPricingVenue
GMP Audit and ICH Q11 – API Manufacturing Workshop will discuss the impact of ICH Q7-Q13 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow. This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing. By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements.

This seminar will examine the expected practices and expectations as defined in the “Guidance for Industry, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”. Participants will learn about the legislators perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers. In addition, attendees will define the critical steps to review during an audit. To ensure complete understanding, practical and interactive Activities will be conducted.


  • Quality Assurance Management and Staff
  • Quality Control Management and Staff
  • Manufacturing Management and Staff
  • Production Management and Staff
  • Regulatory Affairs Management and Staff
  • Operations Management and Staff
  • Laboratory Personnel
  • Chemists
  • Microbiologists
  • Process Engineering Teams
  • Design Engineering Teams
  • Process Automation Teams
  • Validation Teams

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

Applicable Regulations and Guidance documents for APIs

  • ICH Q7..Good Manufacturing Practice Guide for APIs
  • Quality System Regulations (QSR)
  • ICH Q10..Pharmaceutical Quality Systems
  • The QMS tools which are oversight by many companies
  • Management review, Compliance improvement plan
  • Quality oversight procedures
  • Trending of QMS tools – Benefits, How to prepare trend of deviations, change controls, market complaint, OOS, OOT etc
  • ICH Q11 Guideline.. Development and Manufacture of Drug Substances
  • ICH Q12 .. How it complements the existing ICH Q8 to Q11 Guidelines
  • ICH Q13 .. Continuous Manufacturing of Drug Substances and Drug Products

Process Development and Controls

  • Manufacturing process development
  • Process controls
  • Role of CPP and CQA in process development
  • Selection of starting materials
  • Control strategy
  • Process validation evaluation
  • Submissions (eCTD)

Toxic Impurities

  • Handling trace analysis
  • Types of Impurities and Limits
  • Structure and properties of Impurities (e.g. NDMA, NDEA and NMBA)
  • Other potential toxic impurities
  • Case Study on recent Nitrosoamines issues

Activity 1: Triggering the thought process for assigning CAPA
Activity 2: Life Cycle management

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 5 PM)

Topics commonly associated with each:

  • Quality management
  • Personnel
  • Buildings and Facilities
  • Process equipment
  • Documentation and records
  • Change control and validation
  • Complaints and recalls
  • Packaging and labelling

GMP Audits

  • Auditing approach for API manufacturers and areas of focus
  • Leading the audit
  • Audit readiness Vs Audit preparedness
  • Do’s and Don’t during audits
  • Typical audit checklist and preparation before audit. Review of typical issues
  • Expectations for actions taken after audit
  • Follow-up and continuous improvement steps
  • Handling confidential information

Supplier qualification and areas covered in quality agreements

  • Scope
  • Responsibilities
  • Duration
  • Notification of changes/evaluation
  • Handling of deviations

Activity 1: Practical cases considering possibilities of failures in productions
Activity 2: Practical ways for evaluation of organization influences in data integrity and identifying need for the same

Q&A, Certification, Networking and Close: 4.30 PM – 5 PM


Seats and Accommodation are limited and based on first-come, first-serve


Fortune Landmark – Ahmedabad

Ahmedabad, GJ, India | July 25 – 26, 2019

Call for Assistance: +91-80-4170-0521   Register Now