Podcast
Questions and Answers
What should disinfectants and detergents used in Grade A and B areas be before use?
What should disinfectants and detergents used in Grade A and B areas be before use?
Sterile
Why should a disinfectant programme include a sporicidal agent?
Why should a disinfectant programme include a sporicidal agent?
Because many common disinfectants are ineffective against spores.
What is the purpose of fumigation of clean areas?
What is the purpose of fumigation of clean areas?
To reduce microbial contamination in inaccessible places
How are clean areas for the manufacture of sterile products classified?
How are clean areas for the manufacture of sterile products classified?
What is used to determine the classification of cleanliness according to the concentration of airborne particles?
What is used to determine the classification of cleanliness according to the concentration of airborne particles?
What is Grade A in the context of clean areas?
What is Grade A in the context of clean areas?
What is the purpose of monitoring clean areas for airborne particles?
What is the purpose of monitoring clean areas for airborne particles?
How many grades of clean areas are distinguished for the manufacture of sterile pharmaceutical preparations?
How many grades of clean areas are distinguished for the manufacture of sterile pharmaceutical preparations?
What is the main purpose of implementing WHO good manufacturing practices (GMP) guidelines for sterile pharmaceutical products?
What is the main purpose of implementing WHO good manufacturing practices (GMP) guidelines for sterile pharmaceutical products?
What is the recommended entry point for personnel and/or equipment and materials into clean areas?
What is the recommended entry point for personnel and/or equipment and materials into clean areas?
How should clean areas be maintained?
How should clean areas be maintained?
What is the purpose of supplying clean areas with filtered air?
What is the purpose of supplying clean areas with filtered air?
Why should component preparation, product preparation, filling, and sterilization operations be carried out in separate areas?
Why should component preparation, product preparation, filling, and sterilization operations be carried out in separate areas?
How many grades of clean areas are classified in the WHO GMP guidelines?
How many grades of clean areas are classified in the WHO GMP guidelines?
What is the purpose of using airlocks in the production of sterile preparations?
What is the purpose of using airlocks in the production of sterile preparations?
What is the ultimate goal of implementing WHO good manufacturing practices for sterile pharmaceutical products?
What is the ultimate goal of implementing WHO good manufacturing practices for sterile pharmaceutical products?
What is the airborne particle classification for Grade C at rest and in operation?
What is the airborne particle classification for Grade C at rest and in operation?
According to ISO 14644-1 (2), what is the basis for determining the minimum number of sample locations and sample size?
According to ISO 14644-1 (2), what is the basis for determining the minimum number of sample locations and sample size?
What is the minimum sample volume per location required for lower grades (Grade C in operation and Grade D at rest)?
What is the minimum sample volume per location required for lower grades (Grade C in operation and Grade D at rest)?
Why should portable particle counters with a short length of sample tubing be used for classification purposes?
Why should portable particle counters with a short length of sample tubing be used for classification purposes?
In what type of systems should isokinetic sample heads be used?
In what type of systems should isokinetic sample heads be used?
What are the three options for demonstrating 'in operation' classification?
What are the three options for demonstrating 'in operation' classification?
What standard provides information on testing to demonstrate continued compliance with the assigned cleanliness classification?
What standard provides information on testing to demonstrate continued compliance with the assigned cleanliness classification?
Why should clean rooms and clean-air devices be routinely monitored while in operation?
Why should clean rooms and clean-air devices be routinely monitored while in operation?
What factors should be considered when selecting a monitoring system?
What factors should be considered when selecting a monitoring system?
What determines the size of samples taken for monitoring purposes using automated systems?
What determines the size of samples taken for monitoring purposes using automated systems?
What is the purpose of the 'clean-up' or 'recovery' period in clean area monitoring?
What is the purpose of the 'clean-up' or 'recovery' period in clean area monitoring?
Where should airborne particles be monitored in a clean area?
Where should airborne particles be monitored in a clean area?
How often should airborne particles be monitored in a clean area?
How often should airborne particles be monitored in a clean area?
What is the purpose of monitoring clean areas for microbial contamination?
What is the purpose of monitoring clean areas for microbial contamination?
What determines the locations and sample sizes for airborne particle monitoring?
What determines the locations and sample sizes for airborne particle monitoring?
What should be considered when designing a sampling plan for airborne particle monitoring?
What should be considered when designing a sampling plan for airborne particle monitoring?
What is the purpose of establishing levels of detection of microbial contamination in a facility?
What is the purpose of establishing levels of detection of microbial contamination in a facility?
What is the unit of measurement for microbial contamination in clean areas?
What is the unit of measurement for microbial contamination in clean areas?
What is the purpose of Table 3 in the text?
What is the purpose of Table 3 in the text?
What are the different types of plates used for microbiological monitoring in clean areas?
What are the different types of plates used for microbiological monitoring in clean areas?
Why is additional microbiological monitoring required outside production operations?
Why is additional microbiological monitoring required outside production operations?
Study Notes
WHO Good Manufacturing Practices for Sterile Pharmaceutical Products
Introduction
- The WHO has implemented Good Manufacturing Practices (GMP) guidelines for the production of sterile pharmaceutical products
- These guidelines aim to ensure the quality and safety of sterile pharmaceutical products
General Considerations
- Sterile preparations should be produced in clean areas with controlled access through airlocks
- Clean areas should be maintained to a high standard of cleanliness and supplied with filtered air
- Operations should be carried out in separate areas within the clean area, classified into four grades
Manufacture of Sterile Preparations
- Clean areas are classified into four grades (A, B, C, and D) based on the level of environmental cleanliness required
- Grade A is for high-risk operations, such as filling and making aseptic connections
- Grades C and D have lower levels of cleanliness
- ISO 14644-1 should be used for classification of cleanliness according to airborne particle concentration
Clean Room and Clean-Air Device Monitoring
- Clean rooms and clean-air devices should be routinely monitored while in operation
- Monitoring locations should be based on a formal risk analysis study
- Remote sampling systems should be used, considering particle losses in the tubing
- The selection of the monitoring system should take account of the materials used in the manufacturing operation
Airborne Particle Conditions
- The airborne particle conditions for the "at rest" state should be achieved after a short "clean-up" or "recovery" period
- The particulate conditions for Grade A "in operation" should be maintained in the zone surrounding the product
- The "clean-up" or "recovery" test should demonstrate a change in particle concentration by a factor of 100 within the prescribed time
Microbiological Monitoring
- Clean areas should be monitored for microbial contamination in addition to airborne particles
- Microbiological monitoring should be carried out periodically in operation at critical locations
- Levels of detection of microbial contamination should be established for setting alert and action limits
- Recommended limits for microbial contamination are provided in Table 3
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Description
This quiz is based on the WHO Technical Report Series, No. 961, 2011, Annex 6, which outlines good manufacturing practices for sterile pharmaceutical products.
