SOURCES SOUGHT
81 -- Labeling of Pharmacuticals
- Notice Date
- 10/28/2003
- Notice Type
- Sources Sought
- Contracting Office
- Attn: Department of Veterans Affairs National Acquisition Center, (049A1), P.O. Box 76, Building No. 37, Hines, Illinois 60141
- ZIP Code
- 60141
- Solicitation Number
- M8-Q1-04
- Response Due
- 11/10/2003
- Point of Contact
- Point of Contact - Jose Rodriguez, Contracting Officer, (708) 786-4952, Contracting Officer - Jose Rodriguez, Contracting Officer, (708) 786-4952
- E-Mail Address
-
Email your questions to Jose Rodriguez
(jose.rodriguez2@med.va.gov)
- Description
- The SNS Program working with the Food and Drug Administration (FDA) has established an expiration dating extension program for medical products managed by the SNS Program. This program will require the contractor to design and establish FDA and Drug Enforcement Agency (DEA) approved policies and procedures to re-label stockpile products with the extended expiration dating while assuring that all other FDA and DEA mandated labeling and packaging and storage criteria are maintained during the re-labeling process and to actually perform and document the re-labeling processes at the contractors licensed facility. To accomplish this action, the following must occur: 1) The Contractor must design and establish policies and procedures detailing each step in the re-labeling process specific to the SNS program. These policies and procedures must confirm to existing FDA and DEA mandated regulations and comply with current Good Manufacturing Practices to prevent the misbranding or adulteration of SNS products. 2) Either the SNS Program or the contractor will ship the product for re-labeling to the Contractors FDA and DEA licensed facility for processing. The contractor must maintain an FDA licensed Re-labeling facility adequate in size to manage the projected volume required of this project. All transportation vehicles utilized must be able to maintain environmental and be able document these conditions to ensure the integrity of the products being shipped. All vehicles must also have the capability to be tracked and contacted to verify the location of all the SNS programs assets at anytime during transport. * The contractor must provide pricing for this project based on two shipping parameters. The first will be for product shipped to and from the Contractors re-labeling facility with all shipping coordinated and managed by the SNS. The second parameter will be for the Contractor to develop an SNS approved shipping program, controlled by the Contractor but monitored by the SNS. 3) The contractor to design a program that would require the contractor to establish and train a re-labeling team of contractor employees to visit each one of confidential SNS storage site locations within the United States and it?s territories on a regular and ongoing basis for the purpose of performing the re-labeling process to include all of the requisite policies, procedures, and ongoing documentation acceptable to the FDA for remote re-labeling of multiple manufacturer?s medical materiel. The contractors remote re-labeling will be escorted by SNS program logisticians and must be able to sign a non-disclosure statement to keep storage on a need to know basis. The procedures must be designed and detailed in a unique manual controlled by the contractor with a copy of the manual distributed to each SNS storage site. Each copy of the manual must be assigned a control number for proper tracking. The contractor will be responsible for providing the SNS Program with ongoing updates to the manual consistent with any changes mandated by the FDA, DEA, and or ongoing amendments to applicable regulations governing the storage, packaging, and labeling of medical materiel. 4) The contractor must establish statistically acceptable procedures for the inspection of each lot of product to be re-labeled, to assure the product is properly and adequately identified, that the product to be relabeled consists of a single lot of a single product, from a single original manufacturer, that each container in the lot has an identical original manufacturers expiration date and that the original manufacturer packaging system remains intact and acceptable for the re-labeling processes. 5) The Contractor must establish applicable forms and records that are adequate to properly, accurately, and consistently document all of the steps required under the regulations to actually perform the re-labeling process on multiple original manufacturers product maintained by the SNS Program and to maintain these records in a manner acceptable to the FDA and DEA. 6) Upon the request of the SNS Program the contractor must be able to design procedures for creating new product labeling that confirms with existing FDA and DEA labeling regulations. The Contractor must ensure the new labeling is identical in content as the original labeling except for the new extended dating information and that each label is adhered to the manufacturer?s original container with pharmaceutical grade glue to ensure it cannot be easily removed by the end user. 7) The contractor will be responsible for attaching the new labeling to each applicable product container and assuring a complete and accurate reconciliation and documentation of each lot of labels used in the re-labeling process to prevent the inadvertent mislabeling of any other product. 8) The contractor will be responsible for re-labeling the outer cartons of each manufacturer lot of product in addition to each drug container to assure complete labeling consistency between the outer and inner labeling for each product. 9) The contractor will be responsible for maintaining accurate records of all re-labeling activities that assure complete and ongoing trace ability of each step in the re-label process for annual review by the FDA or DEA. 10) The contractors must be registered and have applicable licenses with the FDA and DEA in the areas of manufacturing, packaging, and labeling. Require contractor have background and expertise in FDA and DEA approved re-labeling programs for human drugs and medical devices. 11) The contractor must maintain an FDA licensed Re-labeling facility adequate in size to manage the projected volume required of this project. 12) The contractor must maintain an FDA and DEA approved employee-training program to assure all employees involved in this project are adequately, properly and routinely trained in FDA current Good Manufacturing Practices, DEA regulatory compliance, and that each employee is competent to perform the tasks assigned to them regarding this project. 13) The decision to defer or complete re-labeling will be made by the SNS Program based on urgency of need and timeline for re-labeling in a contingency situation.
- Web Link
-
RFP M8-Q1-04
(http://www.bos.oamm.va.gov/solicitation?number=M8-Q1-04)
- Record
- SN00460778-W 20031030/031028213159 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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