ESBD_File_328856_RFP 515-2-0003 Q and A Lab.doc

RFP 515-21-0003 Q&A DOCUMENT

STATE OF TEXAS

TEXAS STATE BOARD OF PHARMACY

REQUEST FOR PROPOSAL NO. 515-23-0003

LABORATORY SERVICES

ADDENDUM 1

QUESTIONS AND RESPONSES

It is the responsibility of respondents to read and acknowledge the questions and responses below. Respondents must sign and return the acknowledgement with proposals.

Organization Name:____________________________________________________

Signature of Authorized Representative:___________________________________

Date:_________________________________________________________________

Printed Name and Title:_________________________________________________

QUESTION: 1.0 - Will Texas State Board of Pharmacy provide a reference to USP methodology for fungus testing?

ANSWER: The Texas State Board of Pharmacy will provide vendors with any guidance methodology as necessary. Proposers may offer their own solution for the specification, subject to review by the Texas State Board of Pharmacy.

QUESTION: 2.1.3 – Please clarify the statement “. . . if equipment is inoperable, they will notify TSBP in writing within 24 hours of determination of inoperability.” Does this statement refer only to times when TSBP may be impacted by downtime? Or does this statement refer to anytime the contractor's equipment is inoperable?

ANSWER: TSBP must be notified of equipment inoperability if there will be a delay in testing samples submitted by TSBP.

QUESTION: 2.2.5 – Please define TSBP’s validation requirements for potency, sterility, endotoxin, and fungal tests.

ANSWER: USP methods do not require validation. This statement is referring to newly developed methods. Please refer to 2.2.6 for further clarification.

QUESTION: 2.2.7 – Does the term “written results” refer to results in a Certificate of Analysis?

ANSWER: Yes.

QUESTION: 2.2.7 – What details about the test method does TSBP require?

ANSWER: The initial report only requires basic information such as the name of the testing method used to achieve results. However, TSBP may request additional testing data in the event of a prosecutorial case.

QUESTION: 2.2.12 – If USP does not have a monograph for a specific product being tested, is the contractor able to assign the acceptable range as they see fit?

ANSWER: Contractor may temporarily assign a range provided that the decisions for range is based on sound primary literature that can be reviewed and approved by TSBP

QUESTION: 2.2.13 – With reference to “providing a description of the testing methods used for sterility testing per USP 71”, does TSBP require description one time or with every sample? What level of detail would TSBP like with method description?

ANSWER: Please refer to the answer for 2.2.7.

QUESTION: 2.2.14 – Please define “other related activities as assigned by the TSBP.” Please provide examples.

ANSWER: This clause allows the agency to order related services as needed, to deal with unexpected circumstances as part of our regulatory duties. We cannot define these in advance, since the purpose is to allow latitude to deal with unexpected needs related to laboratory analysis of pharmaceuticals.

QUESTION: 2.3.4 – Please define “regular basis”.

ANSWER: Typically, this is a monthly report. However, TSBP reserves the right to make the frequency as often as meets our business needs.

QUESTION: 2.4.1 – Please clarify level of detail for “contractor shall indicate the equipment that was utilized to test the drug product.” For example, is HPLC sufficient?

ANSWER: The purpose of the requirement is to get enough detail to match the charges on the invoice to the contract. Simple descriptions like HPLC should be sufficient.