WHO Good Manufacturing Practices for Sterile Pharmaceutical Products
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Questions and Answers

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?

Because many common disinfectants are ineffective against spores.

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?

<p>According to the required characteristics of the environment</p> Signup and view all the answers

What is used to determine the classification of cleanliness according to the concentration of airborne particles?

<p>ISO 14644-1</p> Signup and view all the answers

What is Grade A in the context of clean areas?

<p>The local zone for high-risk operations, e.g. filling and making aseptic connections</p> Signup and view all the answers

What is the purpose of monitoring clean areas for airborne particles?

<p>To minimize the risks of particulate contamination of the product or materials being handled</p> Signup and view all the answers

How many grades of clean areas are distinguished for the manufacture of sterile pharmaceutical preparations?

<p>Four</p> Signup and view all the answers

What is the main purpose of implementing WHO good manufacturing practices (GMP) guidelines for sterile pharmaceutical products?

<p>To ensure the production of high-quality and safe sterile preparations.</p> Signup and view all the answers

What is the recommended entry point for personnel and/or equipment and materials into clean areas?

<p>Through airlocks.</p> Signup and view all the answers

How should clean areas be maintained?

<p>To an appropriate standard of cleanliness.</p> Signup and view all the answers

What is the purpose of supplying clean areas with filtered air?

<p>To maintain a safe and controlled environment for the production of sterile preparations.</p> Signup and view all the answers

Why should component preparation, product preparation, filling, and sterilization operations be carried out in separate areas?

<p>To prevent cross-contamination and maintain a high level of cleanliness.</p> Signup and view all the answers

How many grades of clean areas are classified in the WHO GMP guidelines?

<p>Four.</p> Signup and view all the answers

What is the purpose of using airlocks in the production of sterile preparations?

<p>To reduce the risk of contamination and maintain a controlled environment.</p> Signup and view all the answers

What is the ultimate goal of implementing WHO good manufacturing practices for sterile pharmaceutical products?

<p>To ensure the production of high-quality and safe sterile preparations.</p> Signup and view all the answers

What is the airborne particle classification for Grade C at rest and in operation?

<p>ISO 7 and ISO 8, respectively</p> Signup and view all the answers

According to ISO 14644-1 (2), what is the basis for determining the minimum number of sample locations and sample size?

<p>The class limit of the largest particle size considered and the method of evaluation of the data collected</p> Signup and view all the answers

What is the minimum sample volume per location required for lower grades (Grade C in operation and Grade D at rest)?

<p>At least 2 litres</p> Signup and view all the answers

Why should portable particle counters with a short length of sample tubing be used for classification purposes?

<p>To avoid the loss of particles ≥ 5.0 μm</p> Signup and view all the answers

In what type of systems should isokinetic sample heads be used?

<p>Unidirectional airflow systems</p> Signup and view all the answers

What are the three options for demonstrating 'in operation' classification?

<p>Normal operations, simulated operations, or during media fills as worst-case simulation</p> Signup and view all the answers

What standard provides information on testing to demonstrate continued compliance with the assigned cleanliness classification?

<p>ISO 14644-2 (6)</p> Signup and view all the answers

Why should clean rooms and clean-air devices be routinely monitored while in operation?

<p>To ensure continued compliance with the assigned cleanliness classification</p> Signup and view all the answers

What factors should be considered when selecting a monitoring system?

<p>The risk presented by the materials used in the manufacturing operation, such as live organisms or radiopharmaceuticals.</p> Signup and view all the answers

What determines the size of samples taken for monitoring purposes using automated systems?

<p>The sampling rate of the system used.</p> Signup and view all the answers

What is the purpose of the 'clean-up' or 'recovery' period in clean area monitoring?

<p>To demonstrate a change in particle concentration by a factor of 100 within a prescribed time.</p> Signup and view all the answers

Where should airborne particles be monitored in a clean area?

<p>In the zone immediately surrounding the product whenever the product or open container is exposed to the environment.</p> Signup and view all the answers

How often should airborne particles be monitored in a clean area?

<p>Periodically, in operation, at critical locations.</p> Signup and view all the answers

What is the purpose of monitoring clean areas for microbial contamination?

<p>To demonstrate control of the cleanliness of the area during operation.</p> Signup and view all the answers

What determines the locations and sample sizes for airborne particle monitoring?

<p>An assessment of the process and contamination risk.</p> Signup and view all the answers

What should be considered when designing a sampling plan for airborne particle monitoring?

<p>The process and contamination risk.</p> Signup and view all the answers

What is the purpose of establishing levels of detection of microbial contamination in a facility?

<p>To set alert and action limits and to monitor trends in environmental cleanliness.</p> Signup and view all the answers

What is the unit of measurement for microbial contamination in clean areas?

<p>Colony-forming units (CFU)</p> Signup and view all the answers

What is the purpose of Table 3 in the text?

<p>To provide recommended limits for microbial contamination in clean areas.</p> Signup and view all the answers

What are the different types of plates used for microbiological monitoring in clean areas?

<p>Settle plates and Contact plates</p> Signup and view all the answers

Why is additional microbiological monitoring required outside production operations?

<p>After validation of systems, cleaning, and sanitization.</p> Signup and view all the answers

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.

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