U -- Science and Technology Training

Request for Information (RFI) - Responses to this RFI are due no later than Jan 12, 2006 at 2:00 pm EST. STATEMENT OF NEED The Food and Drug Administration (FDA) has a continuing need to train its field and headquarters operational personnel in biotechnology/pharmaceutical topics. The Food and Drug Administration's Office of Regulatory Affairs (ORA) trains field and headquarters investigators and analysts to conduct inspections of biopharmaceutical and pharmaceutical manufacturing processes and practices for compliance with GMP/GLP regulations through its Division of Human Resource Development (DHRD). We seek the opportunity to expose course participants to product development; pharmaceutical and biopharmaceutical facility and equipment design; technology transfer; product manufacturing processing; products; and analytical testing methods. FDA's ORA field employees are dispersed over a large geographic area. Therefore the interest, at this time, is to offer training in the pharmaceutical area via distance learning - ORA employees have access to web based training from their desktop. DHRD is interested in working with an educational institution with pilot scale cGMP biopharmaceutical manufacturing capabilities to provide training to ORA employees. Additionally, DHRD is interested in the institution having the capability to easily adjust to rapid changes in the technology in the pharmaceutical manufacturing processes. The capability would allow training in quality systems for ORA field employees to prepare them to inspect the pharmaceutical firms that FDA regulates employing knowledge of the state of the art technology. DHRD is also interested in an education institution that does not produce for profit pharmaceutical products as that would create a conflict of interest. DHRD is also interested in the possibility of expanding the opportunities for training from an educational institution to include other product areas that FDA regulates, e.g. food, biologics, medical devices. Pharmaceutical topics we are interested in include, but are not limited to: Background in FDA-mandated regulatory issues governing the pharmaceutical industries 1. Manufacturing systems, processes and controls, for example: a. Quality systems b. Facilities and equipment i. Mixers/blenders ii. Dryers iii. Mills iv. Presses v. Coaters vi. Lyophilizers vii. Utilities c. Materials i. Raw material receipt, storage, sampling, and dispensing ii. Containers and closure systems d. Production i. Active pharmaceutical ingredient (API) production ii. Tablet manufacturing iii. Capsule manufacturing iv. Transdermal manufacturing v. Liquid manufacturing (including solutions and suspensions) vi. Semi-solid manufacturing vii. Sterile manufacturing (including sterilization principles, methods, equipment) viii. Lyophilization ix. In-process testing x. Cleaning e. Packaging and labeling f. Laboratory equipment, testing and procedures, stability testing and finished product testing Biopharmaceutical topics we are interested in include but are not limited to: 2. Manufacturing components a. Master Cell Bank (MCB) and Working Cell Bank (WCB) b. Media, buffers c. Containers and closures 3. Manufacturing process (aseptic/controlled processes) and equipment as they relate to: a. Endotoxin b. Fermentation/Bioreactors c. Disruption and harvest c. Purification e. Viral inactivation/removal f. Lyophilization g. Equipment such as: Fermenters/bioreactors,chromatography columns, centrifuges, and filters 4. Validation 5. Environmental controls/monitoring 6. Cleaning/Cross contamination 7. Non-conforming product a. Investigations b. Reworking/reprocessing c. Complaints d. Recalls e. Deviations f. AERs 8. GMP Topics a. Equipment i. Equipment and procedures e.g., autoclaves, heat treatment baths, filling equipment lyophilizers, depyrogenation equipment ii. Qualification and requalification iii. Cleaning iv. Calibration b. Buildings i. Lighting, ventilation, temperature, humidity, air pressure, filtration, airborne contamination, and static electricity ii. Note: Spore-forming products and water systems iii. Clean in Place (CIP) and Sterilization in Place (SIP) systems c. Quality Control d. Personnel/Training e. Waste processing f. Packaging and Labeling g. Records i. Master production ii. Batch Records iii. Distribution iv. Stability h. Lot release 9. Testing and Laboratory controls OBJECTIVES The objective is to provide FDA field and headquarters personnel with the latest science and technology training to equip employees to conduct inspections of the pharmaceutical industry. RESPONSE GUIDANCE In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This RFI is issued solely for information and planning purposes only, and does not constitute a solicitation. Responders are solely responsible for all expenses associated with responding to this RFI. Classified information will be accepted, but mark it accordingly and send it via proper channels. Respondents are advised that FDA is under no obligation to acknowledge receipt of the information received, or provide feedback to respondents with respect to any information submitted under this Request for Information (RFI). Please submit a detailed capability statement outlining the necessary knowledge, skills and abilities in meeting the Food and Drug Administration requirements. Supplemental materials, such as brochures, white papers, specification sheets, lab and field test results, cost and schedule information, etc. are welcome. If you choose to submit proprietary information, mark it accordingly. CONTACT INFORMATION Responses should forward the requested information via e-mail only to the point of contact listed below. No telephone calls or faxes will be accepted. The following are the Government Point of Contacts (POCs) for this RFI: Kevin Doss Patricia Pemberton 5630 Fisher Lane 5630 Fisher Lane Room 2081 Room 5631 Rockville, Maryland 20857 Rockville, Maryland 20857 kevin.doss@fda.hhs.gov patricia.pemberton@fds.hhs.gov