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Children\'s Hospital of Eastern Ontario MASTER FORMULA SHEET UNSTERILE MANUFACTURING PRODUCT: DEXAMETHASONE 1 mg/mL SUSPENSION Date Prepared: ___FINAL PRODUCT CHECKED BY: ___EXPIRY DATE: ___INGREDIENTSMANUFACTURERDexamethasone 4
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To fill out ch 13 - non-sterile, follow these steps:
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Start by gathering all the necessary information for the form, such as the product details, manufacturing process, and any relevant documentation.
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Begin with the basic information section of the form, including the name of the manufacturer, contact information, and facility details.
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Move on to the product description section and provide accurate details about the non-sterile product, such as the dosage form, composition, and strength.
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Proceed to the manufacturing process section and describe the steps involved in producing the non-sterile product. Include information about the equipment used, batch sizes, and any critical steps or controls.
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Include a section on quality control, where you outline the measures taken to ensure the quality, purity, and potency of the non-sterile product. This may include information about testing procedures, specifications, and acceptance criteria.
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Provide any additional information required by regulations or specific guidelines, such as stability data, packaging details, or any known hazards associated with the product.
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Ch 13 - non-sterile is needed by manufacturers of non-sterile pharmaceutical products. It is a regulatory requirement to provide accurate information about the manufacturing process, product details, and quality control measures for non-sterile products. Compliance with ch 13 - non-sterile helps ensure the safety, efficacy, and quality of non-sterile pharmaceuticals.
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Chapter 13 - non-sterile refers to a section of regulations that outline requirements for handling non-sterile products.
Manufacturers, distributors, and other parties involved in the production and distribution of non-sterile products are required to file ch 13 - non-sterile.
Ch 13 - non-sterile must be filled out according to the specific guidelines provided in the regulations, including providing all necessary information about the non-sterile products.
The purpose of ch 13 - non-sterile is to ensure the safe handling and distribution of non-sterile products to protect public health.
Information that must be reported on ch 13 - non-sterile includes details about the non-sterile products, manufacturing processes, quality control measures, and distribution channels.
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