Chemical Module Quiz - Beginner | Attempts: 92

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| By Jo McEvoy

Jo McEvoy

Community Contributor

Quizzes Created: 1 | Total Attempts: 92

Questions: 12 | Attempts: 92 | Updated: Feb 23, 2023

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Questions and Answers

1.

What are prospective stabilities?
- A.
  
  Stability tests completed routinely (eg annually) during commercial manufacture
- B.
  
  Stability tests completed prior to commercial manufacture
- C.
  
  Stability tests started at the start of commercial manufacture
Correct Answer
B. Stability tests completed prior to commercial manufacture

Explanation
Prospective stabilities refer to stability tests that are conducted before the commercial manufacturing of a product. These tests are performed to assess the stability and shelf-life of the product under various conditions, such as temperature, humidity, and light exposure. By conducting these tests prior to commercial manufacture, companies can ensure that their product remains stable and maintains its quality throughout its intended shelf-life. This helps in preventing any potential deterioration or changes in the product's properties, ensuring its safety and efficacy for consumers.

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2.

If a finished good contains one 3mL syringe and the product has a specific gravity of 1.5, how many grams of chemical should be added to the BOM?
- A.
  
  4.5 g
- B.
  
  2 g
- C.
  
  3 g
- D.
  
  None of the above
Correct Answer
A. 4.5 g

Explanation
The specific gravity of a substance is the ratio of its density to the density of a reference substance. In this case, the specific gravity of the product is given as 1.5. To calculate the amount of chemical that should be added to the BOM, we need to multiply the volume of the syringe (3mL) by the specific gravity (1.5). This gives us 4.5 grams, which is the correct answer.

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3.

What does the expiry date signify?
- A.
  
  Last date you can sell the product
- B.
  
  Last date the customer should use a product
- C.
  
  Last date before a product will harm you if used
- D.
  
  Date the product was manufactured
Correct Answer
B. Last date the customer should use a product

Explanation
The expiry date signifies the last date the customer should use a product. This date is important because after it, the product may no longer be safe or effective to use. It indicates the point at which the product may start to degrade or lose its quality, potentially causing harm or not delivering the intended results. Therefore, it is crucial for consumers to pay attention to the expiry date and avoid using products past this point.

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4.

Formulas should be included in the DHF
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Formulas are confidential and copies should only be kept in Formulation. RA or any other team member who needs the formula should request it directly from Formulation or R&D Chemical.

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5.

Where can you find expiry date information about each specific batch of chemical produced?
- A.
  
  BML / Batch Manufacture Log
- B.
  
  Agile
- C.
  
  Ask manufacturing
- D.
  
  Use a lifeline to call a friend
Correct Answer
A. BML / Batch Manufacture Log

Explanation
The correct answer is BML / Batch Manufacture Log. The BML or Batch Manufacture Log contains information about each specific batch of chemical produced, including the expiry date. This log is used to track and record important details such as the ingredients used, manufacturing dates, and quality control measures. By referring to the BML, one can easily find the expiry date information for a particular batch of chemical.

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6.

Mixing equipment doesn't require IQ/OQ validations.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Mixing equipment does require IQ/OQ validations. IQ (Installation Qualification) and OQ (Operational Qualification) are validation processes used to ensure that equipment is properly installed and functioning correctly. This is important for mixing equipment as it ensures that the equipment is calibrated, meets specifications, and operates within acceptable parameters. Without these validations, there may be risks of improper mixing, contamination, or inconsistent results. Therefore, the statement that mixing equipment doesn't require IQ/OQ validations is false.

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7.

R&D Chemical has a checklist with required deliverables to transfer a new product to QC Lab and Formulation.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The Transfer Checklist is Form RD 4

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8.

The Product Code is synonymous with the chemical part number.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement is false because the product code and the chemical part number are not synonymous. While the product code may include the chemical part number, it typically encompasses additional information such as the manufacturer, version, or other specifications specific to the product. Therefore, the two terms are not interchangeable.

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9.

All of our chemicals can be filled into clear syringes.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement "All of our chemicals can be filled into clear syringes" is false. This implies that every single chemical in their inventory can be filled into clear syringes, which may not be the case. Some chemicals may react with the material of the syringe or may require special storage conditions that are not compatible with clear syringes. Therefore, it is not accurate to say that all chemicals can be filled into clear syringes.

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10.

What does COA stand for?
- A.
  
  Certificate of Analysis
- B.
  
  Certificate of Authenticity
- C.
  
  Compatibility of Analysis
- D.
  
  Chain of Authority
Correct Answer
A. Certificate of Analysis

Explanation
COA stands for Certificate of Analysis. This term is commonly used in various industries, including pharmaceuticals, food, and manufacturing. A Certificate of Analysis is a document that provides detailed information about the quality and composition of a product. It includes test results, specifications, and other relevant data to ensure that the product meets the required standards. This certificate is often required for regulatory compliance, quality control, and customer assurance purposes.

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11.

What does OOS Stand for?
- A.
  
  Out of Specification
- B.
  
  Operation of Synthesis
- C.
  
  Ongoing of Synthesis
- D.
  
  Organization of Stability
Correct Answer
A. Out of Specification

Explanation
OOS stands for "Out of Specification." This term is commonly used in industries such as pharmaceuticals, where it refers to a result that does not meet the predetermined specifications or criteria. When a product or sample is found to be out of specification, it indicates that it does not meet the required quality standards and may need to be investigated or rejected.

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Current Version
Feb 23, 2023

Quiz Edited by
ProProfs Editorial Team
Oct 06, 2016

Quiz Created by
Jo McEvoy

Chemical Module Quiz - Beginner

What are prospective stabilities?

If a finished good contains one 3mL syringe and the product has a specific gravity of 1.5, how many grams of chemical should be added to the BOM?

What does the expiry date signify?

Formulas should be included in the DHF

Where can you find expiry date information about each specific batch of chemical produced?

Mixing equipment doesn't require IQ/OQ validations.

R&D Chemical has a checklist with required deliverables to transfer a new product to QC Lab and Formulation.

The Product Code is synonymous with the chemical part number.

All of our chemicals can be filled into clear syringes.

What does COA stand for?

What does OOS Stand for?