Sol_QR_OTC Screening_All Questions_Responses.pdf
PDF 67 KB Posted
- Solicitation number
- 75F40125Q00335
About this file
This document is a Questions and Responses file for Solicitation No. 75F40125Q00335, addressing vendor inquiries about a laboratory product testing contract. The solicitation involves purchasing 70 different liquid products for various testing purposes, including sterility, endotoxin, and suitability testing. The products will include diverse liquid formulations such as cold and cough medicines, ophthalmics, and washes/rinses, with both aqueous and non-aqueous compositions.
Key details include that the volume per container will vary by product, and the vendor will be responsible for determining the appropriate number of units to batch for each testing type based on container volume. The laboratory will provide a list of products to be purchased, and the products are expected to be filterable using appropriate materials and methods. The responses clarify that previous statements about unit quantities in the Statement of Work (SOW) were errors, and the vendor must flexibly approach testing quantities based on actual product characteristics.
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| File | Type | Posted |
|---|---|---|
| Sol_Doc_75F40125Q00335.docx | DOCX document |
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Solicitation no. 75F40125Q00335 Questions and Responses
1. We noticed that it says that we would need to purchase the product. Can you confirm that this is correct? I assume we would be given a list of items to purchase.
Yes, a list of products to be purchased would be provided. Identifying the number of units per product in the SOW was an error. The number of units per product will vary depending on the volume per container.
2. Can you please confirm that the laboratory will perform the purchase of the 70 products (32 units for each)?
Yes, a list of products to be purchased would be provided. Identifying the number of units per product in the SOW was an error. The number of units per product will vary depending on the volume per container.
3. Could you provide a more detailed breakdown of the 32 units per product? Specifically:
a. How many units are being batched for sterility testing?
i. Identifying the number of units per product in the SOW was an error. The number of units per product will vary depending on the volume per container.
The vendor will need to determine the number of units to be batched for sterility testing based on the volume per container.
b. How many are being batched for endotoxin testing?
i. Identifying the number of units per product in the SOW was an error. The number of units per product will vary depending on the volume per container.
The vendor will need to determine the number of units to be batched for endotoxin testing based on the volume per container.
c. Does this include suitability testing?
i. The vendor ensure sufficient quantities of product are purchased to facilitate all testing – sterility, endotoxins, and suitability.
d. What is the volume per container for each product?
i. The volume per container will vary depending on the product.
e. Do you also have more information on what type of products they will be? If the products come in liquid form, are they filterable?
i. The anticipated products will be liquid formulations. Some products may be aqueous-based and should be easily filterable. Some products may also be non-aqueous. For example, we anticipate products such as cold and cough, ophthalmics, and washes/rinses on the list. These products should be easily filtered when the appropriate materials and methods are used for testing.
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