Given the necessity of scaling manufacturing of existing products and developing more specialised, patient-centric drugs, the pharmaceutical industry is expanding into new markets. This market shift highlights the requirement to set up new, owned manufacturing sites or set up new contract manufacturing relationships. Therefore, the industry must ensure in parallel that individuals are upskilled to the GMP principles – it is paramount now more than ever.

This course is intended to provide you with an introduction to the fundamental principles of pharmaceutical GMP (PIC/S), the regulatory environment and product realization through market authorization, manufacturing, and lifecycle requirements.

Practical activities throughout the day will give you opportunity to illustrate your acquired knowledge of pharmaceutical GMP, so that the understandings can be utilized in the workplace on completion of the course.

Course Aim

Gain an understanding of the fundamental principles of pharmaceutical GMP and how compliance affects product quality.

How will I benefit?

This course will help you to:

• Gain fundamental knowledge of pharmaceutical GMP and how it links regulation to the regulator(s) and related Good Practices (GxP)
• Identify the key requirements of pharmaceutical GMP
• Gain a fundamental understanding of GMP compliance on product quality

What will I learn?

Upon completion of this course, you’ll be able to:

• Describe what a medicine is
• Describe what pharmaceutical GMP is
• Identify types of GxP’s and the relationship to medicine life-cycle
• Define key requirements of pharmaceutical GMP
• Appreciate fundamental GMP principles
• Recognize the role of the GMP regulator in a global market
• Identify the quality management systems within GMP

Who should attend?

The course is ideal for anyone involved in a pharmaceutical organization, including research and development (R&D), onsite dispensary/warehousing, production, packaging and labelling, quality control/quality assurance; or if you’re in a role within an organization that supplies such organizations with services or materials (raw materials, Active Pharmaceutical Ingredient (API), filters, packaging materials or consumables).

Duration

1 day

How will I learn?

Our high impact, accelerated learning approach increases learning by improving knowledge retention and skill application. This course is presentation and activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

There are no formal prerequisites for this course.

Further Information

Detailed course notes provided.

Related Training

Pharmaceutical Good Distribution Practice (GDP) Training Course

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.