Chemical Module Quiz - Beginner

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.

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.

The Transfer Checklist is Form RD 4

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.

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.

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.

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.

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.

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.

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.

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.