Professions : Employee in pharmaceutical industry. An interactive tutorial scenario.
Expertise developed :
Attests to mastery of the knowledge and abilities associated with Level 1 of Good Manufacturing Practices collective e-learning training:
· UC1 – Familiarity with the requirements of the pharmaceutical quality system and the 5 Whys to assure product quality and patient safety.
· UC2 Labour force – Applying hygiene and gowning rules with appropriate PPE according to production zone classifications.
· UC3 Process – Applying and maintaining documentation best practices (SOP, MOP etc.), and rules for production record-keeping (log book, batch file, checklist etc.).
· UC4 Environment – Taking the necessary measures to minimise the risk of cross-contamination:
– Follow traffic flows for materials and persons.
– Integrate cleaning best practices for the production environment, respecting the 5 Ss.
– Identify the special characteristics of a GMP area and the associated identification-, storage- and cleaning rules.
· UC5 Equipment – Applying line spacing rules to prevent cross-contamination.
· UC6 Materials – Identifying the compliance of materials according to documentary best practices, to ensure traceability of the product over the entire manufacturing process.
Exercises to reinforce acquisition and learning :
2 downloadable PDF format pedagogical documents over this E-GMP Level 1 training course, with primary objectives and key points for training:
1. Essential principles for the work environment presented in unit UC4 Environment, with the following key points:
– Good Manufacturing Practices for medications for human consumption.
– Vectors of contamination.
– Premises and materials.
2. The 12 essential principles of documentary best practices presented in skills unit UC3 Process, with the following key points:
– Completing documentation and recommendations to prevent errors.
– Documents at the work station: procedures and instructions for filing (batch file, manifest, anomaly/incident files and production controls).
Evaluation methods :
The evaluation system is based on periodic multiple-choice quizzes positioned throughout the training course, and a final evaluation. The percentage of correct answers must be equal to or greater than 80% to obtain the Level 1 E-GMP certificate.
Otherwise, with a score of 50% to 79%: the candidate may study the documents presented and retake the Level 1 E-GMP training course.
The number of attempts is noted on the evaluation result sheet.
Ability certificate :
6 ability units
Benefits of the training course :
· E-learning training format.
· Innovative pedagogical method with a serious game.