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Bio LIMS INC

Bio LIMS INC’s 5M

Updated: Oct 12


#1: Man    (Personnel)


  • Personnel are the foundation of any successful quality control system. Employees must be properly trained, qualified, and aware of their responsibilities.

  • Regular training programs should be implemented to ensure personnel stay up-to-date with the latest practices, regulations, and techniques.

  • Job descriptions and responsibilities should be clearly defined to avoid any confusion or overlap.

  • Employees should also be encouraged to participate in continuous improvement efforts and report any potential issues or improvements.

#2: Machine  (Equipment)


  • Equipment used in pharmaceutical laboratories must be reliable, accurate, and properly maintained.

  • A comprehensive inventory of all equipment should be maintained, including calibration schedules and maintenance records.

  • Regular inspections and preventative maintenance should be performed to ensure equipment is in optimal working condition.

  • Employees should be trained on how to properly use and maintain equipment to avoid any damage or accidents.


#3: Material  (Reagent)


  • The quality of raw materials and supplies directly impacts the quality of the final product.

  • Materials should be sourced from reliable and approved suppliers that meet strict quality standards.

  • Incoming materials should be subject to rigorous quality control checks to ensure they meet specifications.

  • Materials should be stored in appropriate conditions to preserve their quality and prevent any contamination or degradation.


#4: Method (Procedures and Protocols)


  • Standard operating procedures (SOPs) should be developed and documented for all critical laboratory activities.

  • SOPs should be reviewed and updated regularly to reflect changes in practices, regulations, or equipment.

  • Personnel should be trained on and follow the SOPs to ensure consistency and accuracy in testing and analysis.

  • Records of all laboratory activities should be maintained for traceability and auditing purposes.


#5: Environment (Facility and Workspace)


  • The laboratory facility and workspace must be clean, organized, and safe.

  • The environment should be controlled to ensure it does not adversely affect the quality of the work or the safety of personnel.

  • Appropriate safety measures should be implemented, such as fire extinguishers, emergency exits, and ventilation systems.

  • The facility should meet all relevant regulatory standards for cleanliness, safety, and environmental control.

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