GMP Case Studies API

Target Group

Staff who work in a facility that manufactures active pharmaceutical ingredients.

Prior Knowledge:
Some prior GMP knowledge is required.

Using videos from GMP facilities!

Languages available:
Dutch, German, English, (Mandarin) Chinese and Spanish.

Study time:
3 hours
(1.5 hours per part)

Questions to:
Phone +49(0)6221 / 84 44 0 - e-Mail: info (at) concept-heidelberg.de


BOOK Part 1 (€ 90)

BOOK Part 2 (€ 90)


Do you want to book this course for more than 10 employees?
Send us an inquiry with the title of the course and the number of participants. We will make you a special offer.


The course consists of 20 practical cases which present typical situations in API production facilities. Those situations are transferable to any production facility. Essential GMP behaviour rules - like for example working concentrated, respecting the instructions from the PI sheet, consulting the superior in cases of uncertainty and filling in the batch records correctly and immediately - are an essential part of this training course. How to handle with technical incidents and damages of the equipment? How to protect the product from contamination and cross contamination? All these questions find an answer in the course, which is made of video sequences and questions about each situation. The videos show situations about performing an IPC, filling in end products, weighing of raw materials, label printing, equipment and premises cleaning and production facility maintenance, etc.

Attendance certificate from  CONCEPT HEIDELBERG

Costs - individuals
Part 1: € 90,- plus VAT
Part 2: € 90,- plus VAT.
Both parts: € 155,- plus VAT

Costs - company licence
Companies which yearly train more than 50 employees can aquire a company licence. Depending on the use, courses can be carried out for under € 30,- per training hour.

Part 1
    The following 10 case studies are covered:
    1. Use of almost expired reagents
    2. Keep doors closed even when it's hot
    3. Sampling after a change in the procedure
    4. Filling the reactor and problems with the double-check
    5. Pump over liquid after vague instruction
    6. Distraction while filling in process data
    7. Bad communication during a shift transfer
    8. In a hurry while cleaning the reactor
    9. Putting away used tools
    10. Label balancing

BOOK Part 1 (€ 90)

Part 2
    The following case studies are covered:
    1. Discovering a leakage
    2. Spilling during filling
    3. Misunderstandings while adding Hydrochloric acid
    4. Handling deviations in cooling
    5. Weighing of raw materials and double-checking
    6. Cleaning up spilled raw materials
    7. Working above one another
    8. Clothing procedures in filling rooms and how to avoid cross contamination
    9. Cross contamination of equipment and work environment
    10. Health hazards when handling open products and raw materials

BOOK Part 2 (€ 90)


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