PIC/s GMP Annex II is used by Active Pharmaceutical Ingredients (API) and API intermediate manufacturers operating in regulated markets to implement Good Manufacturing Practices (GMP).

This training is designed to give learners an understanding of PIC/s Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs). It provides learners with an understanding of the applicability of the guidelines and its application in the manufacture of active pharmaceutical ingredients and its intermediates. It also enables learners to be more aware of the perspectives of regulatory inspectors and hence more prepared for regulatory inspections.

Objective

At the end of the course, the learner will be able to：

• Identify when to use the guidance
• Interpret the requirements in guidance document.
• Be aware of their contribution in the GMP environment within their organisation.
• Be aware of the perspective of an auditor/ inspector of API/ API intermediate manufacturing sites.

Outline

• Application of PIC/s GMP to API manufacturing
• The Chapters in the guidance document, interpretation and application
  • Introduction
  • Quality Management
  • Personnel
  • Building and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and in-process Controls
  • Packaging and Identification Labelling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Rejection and Re-use of Materials
  • Complaints and Recalls
  • Contract Manufacturers
  • Agents, Brokers, Traders, Distributors, re-packers, and Re-labellers
  • Specific Guidance for APIs Manufactured by Cell Culture / Fermentation
  • APIs for use in clinical Trials
• Non Adherences to PIC/s Guidance
• Conclusion and use at workplace

Who should attend

• Regulatory Affairs/QA Managers/ manufacturing/ technical staff of API or API intermediate manufacturing sites
• Associates who are involved in conducting audits of API or API intermediate suppliers
• Associates who need to have a better understanding of PIC/s GMP and its applications.
• Associates involved in API/ intermediates manufacturing who need to interface health authority inspectors

Methodology

Agnes Lim's Profile

Armed with a BSC (Hons) from the National University of Singapore, a MBA from the University of Hull and an Advanced Certificate for Training and Assessment (ACTA) by Institute of Adult learning (IAL), Agnes Lim has more than 30 years of corporate experience in the biomedical industry of which 20 years were in middle and senior management.

Adept at people management, she has more than 20 years experience in hiring, managing, training and developing staff and more than 10 years experience in succession planning at the site leadership level. She is able to connect with people across different levels in the organisation having worked up the levels in her career. She has conducted more than 300 interviews ranging from junior management staff to site leadership team members to scholarship aspirants at her previous companies.

Being in a technical department, Agnes is equally well versed in technical report writing and technical presentation, having created and reviewed many thousands of technical reports and presentations throughout her career.

Agnes has developed and conducted numerous trainings and coached learners on both technical and soft skills. Examples of trainings that she has conducted include, How Managers and supervisors can Develop Career of their Staff, Hire Right, Managing your Career Development for Success, Technical Writing Skills, Technical Presentation skills, Auditing Skills, Investigations Skills, Data Integrity, Quality Risk Assessments amongst others.

A comfortable and confident speaker, she was invited to speak at BioBiz at NUS previously to help the students have a better understanding of the career opportunities in the biomedical / pharmaceutical industry. She has also shared her educational choices with students at Raffles Girls School (Secondary), her alma mater.

Agnes is passionate about developing and cultivating talents within the organisation. She believes that a keen focus on talent development differentiates organisations and is a competitive advantage.

With a passion for youth and education, she currently volunteers with ACTS Singapore.