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Good Manufacturing Practice (GMP)

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.

Category: Compliance

Industry: Manufacturing

Questions: 13

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Good Manufacturing Practice (GMP)

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.

1. Definition of GMP >
2. Who needs to follow GMP >
3. Controlling manufacturing >
4. Flexible system design >
5. Why are GMPs important >
6. Why use GMPs >
7. Level of compliance >
8. Adulterated drugs >
9. Violations >
10. Risk-based framework >
11. Inspection protocol >
12. Inspection Rigor >
13. Quality problem areas >

Follow the interactions on each screen to answer Qstream questions as a Participant.

GMPs may be referred to as cGMPs, which stands for: _______.

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.

Sarah is talking with her colleague, Jesse, about Good Manufacturing Practices (GMPs) as they review a few production records. Jesse believes that GMPs are used only by drug manufacturing companies like theirs.

Sarah shares that GMPs also apply to companies that work with other types of products, including:

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]

Rene was just promoted to Production Manager at ACME labs. As part of her onboarding process, she is reviewing her specific duties, which require a greater understanding of her company's total operations.

She knows that ACME labs have robust quality management systems but is surprised to learn that the Good Manufacturing Practices (GMPs) implemented throughout the organization include:

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

Current Good Manufacturing Practices (cGMPs) provide for __________ systems that assure the proper design, monitoring, and control of manufacturing processes and facilities.

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.

Amelia watched a news report about a brand of ibuprofen that was being recalled. Although she didn't catch the company's name, she called the toll-free number of the manufacturer of her brand of ibuprofen to find out more. The customer services representative told Amelia that it was a different company and assured her that their products were safe and effective.

When Amelia asked for proof, the representative replied that they adhere to Good Manufacturing Practices (GMPs), which ensure that their:

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.

Marcus and Victoria are chatting about work during their break from the production line at a pharmaceutical company. Marcus complains about the cross-checking and reporting required to comply with Good Manufacturing Practices (GMPs). He suggests their company could save a lot of money if they just focused on manufacturing and not on quality control and reporting regulations.

Victoria replies that their company would actually lose a lot of money if they didn't follow GMPs because:

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

Most pharmaceutical manufacturing facilities that are inspected by the Food and Drug Administration (FDA) are found to be ________ compliant with Good Manufacturing Practice (GMP) regulations.

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.

During a staff meeting about unannounced Food and Drug Administration (FDA) inspections, Samuel asks the presenter what happens when a pharmaceutical company is found to be out of compliance with Good Manufacturing Practices (GMPs).

The presenter tells Samuel and the rest of the staff that under the law, the drugs they would make are considered ________.

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.

Jessica, a vice president of ACME labs, is discussing with her senior managers how crucial it is for the company to follow Current Good Manufacturing Practices (cGMPs). She explains that there are substantial consequences if they are found to be in violation, including:

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]

The Food and Drug Administration (FDA) uses a risk-based framework for prioritizing sites for inspection to ensure compliance with Good Manufacturing Practices (GMPs). This framework rates the risk potential based on the types of:

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

Joseph is a Food and Drug Administration (FDA) agent who is inspecting ACME labs. In doing so, he needs to make sure he arrives at ACME:

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]

As a Food and Drug Administration (FDA) agent, Mary plans to visit Pacific Pharmaceuticals for a routine cGMP (Current Good Manufacturing Practice) inspection. Pacific Pharmaceuticals has had three inspections before with no major compliance violations. Their business has been thriving, and they have expanded their production facility.

With this in mind, what type of inspection should Mary conduct?

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

According to the Food and Drug Administration (FDA), the top quality problem areas most associated with regulatory action regarding Current Good Manufacturing Practices (cGMPs) include which of the following?

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

GMPs may be referred to as cGMPs, which stands for: _______.

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.

Sarah is talking with her colleague, Jesse, about Good Manufacturing Practices (GMPs) as they review a few production records. Jesse believes that GMPs are used only by drug manufacturing companies like theirs.

Sarah shares that GMPs also apply to companies that work with other types of products, including:

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]

Rene was just promoted to Production Manager at ACME labs. As part of her onboarding process, she is reviewing her specific duties, which require a greater understanding of her company's total operations.

She knows that ACME labs have robust quality management systems but is surprised to learn that the Good Manufacturing Practices (GMPs) implemented throughout the organization include:

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

Current Good Manufacturing Practices (cGMPs) provide for __________ systems that assure the proper design, monitoring, and control of manufacturing processes and facilities.

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.

Amelia watched a news report about a brand of ibuprofen that was being recalled. Although she didn't catch the company's name, she called the toll-free number of the manufacturer of her brand of ibuprofen to find out more. The customer services representative told Amelia that it was a different company and assured her that their products were safe and effective.

When Amelia asked for proof, the representative replied that they adhere to Good Manufacturing Practices (GMPs), which ensure that their:

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.

Marcus and Victoria are chatting about work during their break from the production line at a pharmaceutical company. Marcus complains about the cross-checking and reporting required to comply with Good Manufacturing Practices (GMPs). He suggests their company could save a lot of money if they just focused on manufacturing and not on quality control and reporting regulations.

Victoria replies that their company would actually lose a lot of money if they didn't follow GMPs because:

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

Most pharmaceutical manufacturing facilities that are inspected by the Food and Drug Administration (FDA) are found to be ________ compliant with Good Manufacturing Practice (GMP) regulations.

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.

During a staff meeting about unannounced Food and Drug Administration (FDA) inspections, Samuel asks the presenter what happens when a pharmaceutical company is found to be out of compliance with Good Manufacturing Practices (GMPs).

The presenter tells Samuel and the rest of the staff that under the law, the drugs they would make are considered ________.

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.

Jessica, a vice president of ACME labs, is discussing with her senior managers how crucial it is for the company to follow Current Good Manufacturing Practices (cGMPs). She explains that there are substantial consequences if they are found to be in violation, including:

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]

The Food and Drug Administration (FDA) uses a risk-based framework for prioritizing sites for inspection to ensure compliance with Good Manufacturing Practices (GMPs). This framework rates the risk potential based on the types of:

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

Joseph is a Food and Drug Administration (FDA) agent who is inspecting ACME labs. In doing so, he needs to make sure he arrives at ACME:

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]

As a Food and Drug Administration (FDA) agent, Mary plans to visit Pacific Pharmaceuticals for a routine cGMP (Current Good Manufacturing Practice) inspection. Pacific Pharmaceuticals has had three inspections before with no major compliance violations. Their business has been thriving, and they have expanded their production facility.

With this in mind, what type of inspection should Mary conduct?

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

According to the Food and Drug Administration (FDA), the top quality problem areas most associated with regulatory action regarding Current Good Manufacturing Practices (cGMPs) include which of the following?

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

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