Professional knowledge training for inspectors in pharmaceutical production industry

Accurate detection, strict control - medical inspectors training, build a solid line of defense for patient safety

I. Training objectives

1. Enhance professional skills: Ensure that inspectors have a solid theoretical foundation of drug testing and skilled operational skills.

2. Strengthen quality awareness: train inspectors to be highly sensitive and responsible for drug quality.

3. Master regulations and policies: make inspectors familiar with and comply with the relevant laws and regulations on drug production quality management.

2. Training content

1. Basic knowledge of drug testing

• Chemical analysis: including organic chemistry, inorganic chemistry, analytical chemistry and other basic principles and their application in drug testing.

• Instrument analysis: The principle, operation and maintenance of various inspection instruments (such as high performance liquid chromatograph, ultraviolet spectrophotometer, gas chromatograph, etc.) are introduced.

• Microbiology: types of microorganisms, growth conditions, detection methods and aseptic operation specifications.

2. Drug production quality control

• Inspection of raw materials and auxiliary materials: The inspection standards, methods and procedures of raw materials and auxiliary materials entering the factory are introduced in detail.

• Production process monitoring: Explain the monitoring of key process parameters in the production process, cleaning and disinfection of the production environment.

• Finished product inspection: including traits, identification, content determination, microbial limit and other items of inspection methods and standards.

  

3. Quality management system

• GMP Certification Requirements: This section describes the basic requirements and implementation steps of GMP (Good Manufacturing Practice).

• Quality management System construction: explains how to establish and maintain an effective quality management system, including document control, internal audit, continuous improvement, etc.

4. Regulations, policies and industry standards

• National regulations and policies: such as the "Drug Administration Law", "Drug production quality Management practice" and other relevant laws and regulations.

• Industry standards: introduction and application of international and domestic standards such as ISO 15189.

5. Case analysis and practical operation

• Case analysis: Analyze the problems and solutions that may be encountered in the process of drug testing through actual cases.

• Practical operation: Sample collection, processing, testing, result analysis and other practical exercises in the laboratory environment to improve the practical ability of inspectors.

Iii. Training methods

1. Theoretical lectures: Industry experts give lectures, explaining the basic knowledge of drug testing and the latest technological advances.

2. Practical exercise: Under the guidance of the instructor, sample collection, processing, detection and result analysis and other practical exercises.

3. Group discussion: Organize students to have a group discussion and share their learning experience and work experience.

4. Online learning: Using the network platform to provide online learning resources, convenient for students to learn anytime and anywhere.

Iv. Training effect evaluation

1. Completion examination: A closed book examination to check the student's learning results.

2. Practical operation assessment: The practical operation ability of the students is assessed to ensure that the students can master the inspection skills.

3. Student feedback: Collect feedback from students on the content and methods of training in order to continuously improve the quality of training.

Through the above training, inspectors in the pharmaceutical production industry will be able to fully master the professional knowledge and skills of drug inspection, and provide a strong guarantee for the quality of drug production. At the same time, they will also have a stronger sense of quality and regulatory awareness, and contribute their own strength to the safety of patients.