Personal Hygiene – Schedule M

About the Course

This eLearning module highlights the critical role of personal hygiene in maintaining product quality and preventing contamination in pharmaceutical and biotech environments. It covers hygiene best practices, gowning procedures, do’s and don’ts in clean areas, and regulatory expectations. Ideal for all personnel working in GMP- regulated areas, this course reinforces the importance of individual responsibility in ensuring a contamination-free manufacturing environment.

Content

Introduction to Personal Hygiene

• Importance of Personal Hygiene in Pharma Industry
  • Hygiene and Integrated Sanitation Program
  • Schedule M, Revision Dec. 2023
• Schedule M Requirements on Personal Hygiene
  • In Part I: Good Manufacturing Practices for Pharmaceutical Products
  • Appropriate Behavior When Sick and other precautions
  • Importance of Training & Instructions
  • Procedures in Housekeeping & Personal Hygiene
  • Good Instructions
  • Sources of contamination
  • Good Hygiene Practices
  • Body Cleanliness – Body, nails, hair, and hands
  • When and how to wash hands
  • Clothes cleanliness including hair, shoe and beard covers
  • Undesirable practices like smoking, eating, etc.
  • Summary: Part I, Schedule M
  • Part VI: Phytopharmaceuticals: Hygiene during Plant Preparations
  • Part XII of Schedule M: APIs
• Assessing Facility Hygiene
  • Assessing Facility Hygiene and Reviewing Observations
  • Hygiene at Premises
  • Good Design of Premises
  • Sanitation Requirements in Facility
  • Location of Toilets and washing facilities
  • Good Cleaning Program
• Regulatory Observations Related to Personal Hygiene

Summary and Conclusion: Importance of Hygiene in Drug and Pharma Industry

Final Evaluation: 3 attempts to achieve 70% in the evaluation.