USP 795 Compliance Checklist for Pharmaceutical Safety and Quality
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USP 795 Compliance Checklist for Pharmaceutical Safety and Quality
1
Review and understand the guidelines set by USP 795
2
Identify the personnel responsible for achieving compliance
3
Train all personnel on USP 795 requirements
4
Establish a specific area or room for the compounding of non-sterile products
5
Set up procedures for cleaning and disinfecting the compounding area
6
Approval: Cleaning Procedures
7
Develop a plan for routinely checking and maintaining equipment
8
Perform routine checks and maintenance on compounding equipment
9
Create a process for selecting and acquiring compounding ingredients
10
Develop and implement protocols for the compounding process
11
Establish methods for assigning beyond-use dates according to USP 795 guidelines
12
Document each step in the compounding procedure
13
Approval: Compounding Procedures Documentation
14
Set up procedures for the disposal of non-sterile compounding waste
15
Implement quality control processes to ensure the quality of compounded products
16
Approval: Quality Control Processes
17
Prepare for inspections by regulatory bodies
18
Address any issues or complications that arise during the compliance process
19
Keep all records, documents, and training materials up-to-date
20
Continually monitor and update processes to remain compliant with USP 795 changes
Review and understand the guidelines set by USP 795
This task involves reviewing and understanding the guidelines set by USP 795, which are essential for ensuring pharmaceutical safety and quality. By thoroughly understanding these guidelines, you will be able to implement the necessary steps to achieve compliance and maintain high standards. The desired result is a clear understanding of the requirements and implications of USP 795 guidelines. Consider the potential challenges of interpreting complex guidelines and find solutions by seeking clarification from experts or referring to official resources. Required resources include a copy of the USP 795 guidelines and access to any relevant supplementary materials.
Identify the personnel responsible for achieving compliance
In this task, you will identify the personnel who will be responsible for achieving compliance with USP 795 guidelines. This is crucial for ensuring accountability and effective communication throughout the compliance process. Consider the impact of each individual's role and expertise on the overall compliance efforts. The desired result is a clear identification of responsible personnel. Potential challenges may include defining roles for overlapping responsibilities or ensuring adequate coverage during absences. Required resources include a list of personnel and their contact information.
Train all personnel on USP 795 requirements
This task involves training all personnel on the requirements outlined by USP 795. By providing comprehensive training, you will ensure that everyone involved in the compounding process understands their responsibilities and the necessary procedures for compliance. The desired result is a well-informed team that is capable of meeting the requirements of USP 795. Consider potential challenges such as scheduling conflicts or language barriers, and address them by creating a training plan with flexible options or providing translation resources. Required resources include training materials, presentation slides, or access to an online training platform.
Establish a specific area or room for the compounding of non-sterile products
In this task, you will establish a specific area or room dedicated to the compounding of non-sterile products. This is essential for ensuring product integrity and preventing cross-contamination. The desired result is a designated and properly equipped area that meets the requirements of USP 795. Consider potential challenges such as limited space or cost constraints, and address them by exploring alternative options or optimizing existing space. Required resources include a floorplan or layout of the designated area and the necessary equipment for compounding.
1
Mixing Containers
2
Weighing Scale
3
Mortar and Pestle
4
Compounding Hood
5
Labels and Documentation
Set up procedures for cleaning and disinfecting the compounding area
This task involves setting up procedures for cleaning and disinfecting the compounding area. Proper cleaning and disinfection are crucial for maintaining a safe and hygienic environment. The desired result is a documented cleaning and disinfection protocol that adheres to the requirements of USP 795. Consider potential challenges such as selecting appropriate cleaning agents or establishing a regular cleaning schedule, and address them by consulting experts or referring to industry best practices. Required resources include cleaning agents, disinfectants, cleaning equipment, and a cleaning log.
1
Sweeping
2
Mopping
3
Wiping Down Surfaces
4
Disinfecting Equipment
Approval: Cleaning Procedures
Will be submitted for approval:
Establish a specific area or room for the compounding of non-sterile products
Will be submitted
Set up procedures for cleaning and disinfecting the compounding area
Will be submitted
Develop a plan for routinely checking and maintaining equipment
In this task, you will develop a plan for routinely checking and maintaining equipment used in the compounding process. Regular equipment checks and maintenance are essential for ensuring that all equipment is functioning properly and can reliably produce high-quality products. The desired result is a documented plan for equipment checks and maintenance. Consider potential challenges such as identifying appropriate maintenance intervals or coordinating maintenance schedules, and address them by consulting equipment manufacturers or creating a maintenance calendar. Required resources include equipment manuals, maintenance schedules, and maintenance logs.
1
Calibration
2
Cleaning
3
Lubrication
4
Replacement of Parts
Perform routine checks and maintenance on compounding equipment
This task involves performing routine checks and maintenance on the compounding equipment as per the established plan. Regular checks and maintenance help ensure that the equipment remains in good working condition and operates reliably. The desired result is equipment that is properly maintained and consistently produces high-quality products. Consider potential challenges such as limited technical expertise or unavailability of replacement parts, and address them by providing training or establishing relationships with equipment suppliers. Required resources include tools or instruments for equipment checks and any necessary replacement parts.
1
Verify Power Supply
2
Check for Leaks or Malfunctions
3
Inspect Cables and Connections
Create a process for selecting and acquiring compounding ingredients
Develop and implement protocols for the compounding process
Establish methods for assigning beyond-use dates according to USP 795 guidelines
Document each step in the compounding procedure
Approval: Compounding Procedures Documentation
Will be submitted for approval:
Develop and implement protocols for the compounding process
Will be submitted
Establish methods for assigning beyond-use dates according to USP 795 guidelines
Will be submitted
Document each step in the compounding procedure
Will be submitted
Set up procedures for the disposal of non-sterile compounding waste
Implement quality control processes to ensure the quality of compounded products
Approval: Quality Control Processes
Will be submitted for approval:
Implement quality control processes to ensure the quality of compounded products
Will be submitted
Prepare for inspections by regulatory bodies
Address any issues or complications that arise during the compliance process
Keep all records, documents, and training materials up-to-date
Continually monitor and update processes to remain compliant with USP 795 changes
