Good Manufacturing Practice (GMP) regulations are disseminated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. Learn about good manufacturing practices with this starter Qstream microlearning course.
Navigate through the Qstream questions below to preview. Each challenge is designed following Qstream’s best practices for maximum knowledge reinforcement and engagement. This Qstream is free for clients to use as a starting point.
Click on each title to preview the question in the mobile/desktop widget.
Follow the interactions on each screen to answer Qstream questions as a Participant.
Answer explanation:
Current Good Manufacturing Practices (cGMPs) are the main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals. Consumers expect that the medicines that they take meet the quality standards for safety and efficacy.
Answer explanation:
Sarah knows that Good Manufacturing Practices (GMPs) are part of a system for ensuring consistency in the production and quality of products. They are a set of federal regulations that have the rule of law and apply to:
• Manufacturers, processors, and packagers of drugs
• Medical devices
• Some foods
• Blood
Learn More:
Get a quick overview of GMPs by reading this 1-minute article, What is GMP?
[https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp]
Answer explanation:
Rene discovers that Good Manufacturing Practices (GMPs) assures the identity, strength, quality, and purity of drug products are maintained by requiring businesses that manufacture medications, such as ACME labs, adequately control their manufacturing operations. This is accomplished by:
• Establishing strong quality management systems
• Obtaining appropriate quality raw materials
• Establishing and maintaining robust operating procedures
• Detecting and investigating product quality deviations
• Maintaining reliable testing laboratories
Answer explanation:
Current Good Manufacturing Practices (cGMPs) requirements were designed to be flexible to allow every manufacturer to determine individually how best to implement the necessary procedures and controls at their facilities.
The flexibility in the cGMPs allows companies to use the latest innovations, procedures, and equipment to achieve higher quality (and thus a competitive advantage) through continuous improvement.
The "c" in cGMP addresses the use of systems and equipment that are current. What may have been a best practice for preventing contamination or manufacturing errors a decade ago may not be adequate by current industry benchmarks.
Answer explanation:
Amelia knows she is unable to detect that a drug product like ibuprofen is either safe or works as intended just by sight, touch, or smell. Although Good Manufacturing Practices (GMPs) require testing, testing alone does not ensure consistent quality. This is because testing only samples a very small fraction (often less than 0.01%) of a production batch. Therefore, GMPs also address manufacturing conditions. Drugs must be manufactured under GMP conditions and practices to assure that quality is built into the design and manufacturing process at every stage.
Answer explanation:
Although it costs time, money, and effort to follow all of the procedures and guidelines of Good Manufacturing Practices (GMPs), in the long run, prevention is less expensive than finding and addressing mistakes after they have occurred.
Also, GMPs are often a requirement for selling to external markets since they ensure that quality is maintained. For example, If a drug has little or none of the claimed ingredients due to poor manufacturing, it will not have the intended therapeutic effect. At the very least, this will hurt the brand's image of a quality product and ultimately reduce sales. More importantly, it may be a health hazard to consumers, resulting in injury or death.
Learn More:
Find answers to common questions about GMPs by reading this 2-minute article, Medicines: Good Manufacturing Practices
[https://www.who.int/news-room/q-a-detail/medicines-good-manufacturing-processes#:~:text=What%20is%20GMP%3F,through%20testing%20the%20final%20product]
Questions written for this Qstream are based on content from:
1. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
2. https://www.fda.gov/media/89231/download
Answer explanation:
The Food and Drug Administration (FDA) inspects pharmaceutical manufacturing facilities worldwide, including those that manufacture the active ingredients and the finished products. Trained FDA staff follow a standard approach in their investigations and find that most facilities are fully compliant with the Good Manufacturing Practice (GMP) regulations.
Answer explanation:
Adulteration means that a drug was not manufactured under conditions that comply with Good Manufacturing Practices (GMPs). This does not necessarily mean that there is something wrong with the drug; therefore, the Food and Drug Administration (FDA) usually advises consumers to seek advice from their health care professionals before stopping or changing medications. Ultimately, the company risks the potential loss in sales, customer confidence, and satisfaction, or the threat of legal action.
Answer explanation:
Suppose the Food and Drug Administration (FDA) finds a company in violation of Current Good Manufacturing Practices (CGMPs). In that case, they can take action to prevent the possibility of unsafe and/or ineffective drugs being used by consumers. These actions include:
• Stopping the distribution or manufacturing of the product
• Making a recommendation to recall the product. Companies often voluntarily comply with the FDA's request, but the FDA cannot force a company to recall a product
• Bringing a seizure or injunction case to court. In a seizure case, FDA officials can take possession of the product, and in an injunction case, they can order companies to take corrective steps such as repairing facilities, improving cleanliness, and improving employee training
• Bringing a criminal case against a company and seeking fines and jail time
Learn More:
Facts About the Current Good Manufacturing Practices (cGMPs) (5-minute article)
Get a quick overview of the CGMPs from the FDA.
[https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps]
Answer explanation:
The goal of using a risk-based framework is to ensure that Food and Drug Administration (FDA) resources are used effectively and efficiently to prioritize addressing the most significant risks to public health.
In the context of pharmaceutical quality, the level of risk depends on the potential harm associated with poor-quality products. Factors that determine this risk include:
• Types of products that are produced
• Types of processes used in the manufacturing and processing
• Type of facility that is used
Answer explanation:
According to the 2014 General Inspection Protocol, Joseph needs to arrive unannounced at the facility he'll inspect. Once there, he must ask for the most responsible person, show his credentials, issue a written Notice of Inspection, and briefly state the inspection's objective.
Learn More:
Approaches to GMP Inspection (15-minute FDA slide deck)
Explore details about the inspection process.
[https://www.fda.gov/media/89231/download]
Answer explanation:
Mary should conduct a full inspection because there have been significant changes to Pacific Pharmaceuticals since their last inspection - namely the expansion of their production facility. A full inspection would also be warranted when there's an initial establishment inspection or a history of inspection violations.
Mary would be able to perform an abbreviated inspection if there was:
• A good history
• No major changes to operations
• No pattern of recalls and/or problems
Answer explanation:
The top five quality problem areas most associated with regulatory action from not following Current Good Manufacturing Practices (cGMPs) include:
• Investigating and correcting discrepancies or defects
• Micro-controls for sterile and non-sterile
• Stability program
• Process design and qualification (validation)
• Establishing and following sound tests and sampling plans
Answer explanation:
Current Good Manufacturing Practices (cGMPs) are the main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals. Consumers expect that the medicines that they take meet the quality standards for safety and efficacy.
Answer explanation:
Sarah knows that Good Manufacturing Practices (GMPs) are part of a system for ensuring consistency in the production and quality of products. They are a set of federal regulations that have the rule of law and apply to:
• Manufacturers, processors, and packagers of drugs
• Medical devices
• Some foods
• Blood
Learn More:
Get a quick overview of GMPs by reading this 1-minute article, What is GMP?
[https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp]
Answer explanation:
Rene discovers that Good Manufacturing Practices (GMPs) assures the identity, strength, quality, and purity of drug products are maintained by requiring businesses that manufacture medications, such as ACME labs, adequately control their manufacturing operations. This is accomplished by:
• Establishing strong quality management systems
• Obtaining appropriate quality raw materials
• Establishing and maintaining robust operating procedures
• Detecting and investigating product quality deviations
• Maintaining reliable testing laboratories
Answer explanation:
Current Good Manufacturing Practices (cGMPs) requirements were designed to be flexible to allow every manufacturer to determine individually how best to implement the necessary procedures and controls at their facilities.
The flexibility in the cGMPs allows companies to use the latest innovations, procedures, and equipment to achieve higher quality (and thus a competitive advantage) through continuous improvement.
The "c" in cGMP addresses the use of systems and equipment that are current. What may have been a best practice for preventing contamination or manufacturing errors a decade ago may not be adequate by current industry benchmarks.
Answer explanation:
Amelia knows she is unable to detect that a drug product like ibuprofen is either safe or works as intended just by sight, touch, or smell. Although Good Manufacturing Practices (GMPs) require testing, testing alone does not ensure consistent quality. This is because testing only samples a very small fraction (often less than 0.01%) of a production batch. Therefore, GMPs also address manufacturing conditions. Drugs must be manufactured under GMP conditions and practices to assure that quality is built into the design and manufacturing process at every stage.
Answer explanation:
Although it costs time, money, and effort to follow all of the procedures and guidelines of Good Manufacturing Practices (GMPs), in the long run, prevention is less expensive than finding and addressing mistakes after they have occurred.
Also, GMPs are often a requirement for selling to external markets since they ensure that quality is maintained. For example, If a drug has little or none of the claimed ingredients due to poor manufacturing, it will not have the intended therapeutic effect. At the very least, this will hurt the brand's image of a quality product and ultimately reduce sales. More importantly, it may be a health hazard to consumers, resulting in injury or death.
Learn More:
Find answers to common questions about GMPs by reading this 2-minute article, Medicines: Good Manufacturing Practices
[https://www.who.int/news-room/q-a-detail/medicines-good-manufacturing-processes#:~:text=What%20is%20GMP%3F,through%20testing%20the%20final%20product]
Questions written for this Qstream are based on content from:
1. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
2. https://www.fda.gov/media/89231/download
Answer explanation:
The Food and Drug Administration (FDA) inspects pharmaceutical manufacturing facilities worldwide, including those that manufacture the active ingredients and the finished products. Trained FDA staff follow a standard approach in their investigations and find that most facilities are fully compliant with the Good Manufacturing Practice (GMP) regulations.
Answer explanation:
Adulteration means that a drug was not manufactured under conditions that comply with Good Manufacturing Practices (GMPs). This does not necessarily mean that there is something wrong with the drug; therefore, the Food and Drug Administration (FDA) usually advises consumers to seek advice from their health care professionals before stopping or changing medications. Ultimately, the company risks the potential loss in sales, customer confidence, and satisfaction, or the threat of legal action.
Answer explanation:
Suppose the Food and Drug Administration (FDA) finds a company in violation of Current Good Manufacturing Practices (CGMPs). In that case, they can take action to prevent the possibility of unsafe and/or ineffective drugs being used by consumers. These actions include:
• Stopping the distribution or manufacturing of the product
• Making a recommendation to recall the product. Companies often voluntarily comply with the FDA's request, but the FDA cannot force a company to recall a product
• Bringing a seizure or injunction case to court. In a seizure case, FDA officials can take possession of the product, and in an injunction case, they can order companies to take corrective steps such as repairing facilities, improving cleanliness, and improving employee training
• Bringing a criminal case against a company and seeking fines and jail time
Learn More:
Facts About the Current Good Manufacturing Practices (cGMPs) (5-minute article)
Get a quick overview of the CGMPs from the FDA.
[https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps]
Answer explanation:
The goal of using a risk-based framework is to ensure that Food and Drug Administration (FDA) resources are used effectively and efficiently to prioritize addressing the most significant risks to public health.
In the context of pharmaceutical quality, the level of risk depends on the potential harm associated with poor-quality products. Factors that determine this risk include:
• Types of products that are produced
• Types of processes used in the manufacturing and processing
• Type of facility that is used
Answer explanation:
According to the 2014 General Inspection Protocol, Joseph needs to arrive unannounced at the facility he'll inspect. Once there, he must ask for the most responsible person, show his credentials, issue a written Notice of Inspection, and briefly state the inspection's objective.
Learn More:
Approaches to GMP Inspection (15-minute FDA slide deck)
Explore details about the inspection process.
[https://www.fda.gov/media/89231/download]
Answer explanation:
Mary should conduct a full inspection because there have been significant changes to Pacific Pharmaceuticals since their last inspection - namely the expansion of their production facility. A full inspection would also be warranted when there's an initial establishment inspection or a history of inspection violations.
Mary would be able to perform an abbreviated inspection if there was:
• A good history
• No major changes to operations
• No pattern of recalls and/or problems
Answer explanation:
The top five quality problem areas most associated with regulatory action from not following Current Good Manufacturing Practices (cGMPs) include:
• Investigating and correcting discrepancies or defects
• Micro-controls for sterile and non-sterile
• Stability program
• Process design and qualification (validation)
• Establishing and following sound tests and sampling plans
© Qstream, Inc. 2024
All Rights reserved.
Privacy Policy | Terms of Use | Qstream AI Terms & Conditions | Accessibility