82 FR 57280 - Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 231 (December 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 231 (December 4, 2017)
| Page Range | 57280-57280 | |
| FR Document | 2017-26055 |
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)] [Notices] [Page 57280] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26055] [[Page 57280]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6286] Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ. DATES: Submit either an electronic or written proposal to participate in this program by February 2, 2018. See section IV of this document for information on what to include in such proposals. FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240- 402-3969, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background A critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and the drug's commercial life cycle, including the variety of drug manufacturing operations. To support this commitment, CDER has initiated various training and development programs including the 2018 Experiential Learning Site Visit Program. This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug's developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience. II. The Site Visit Program In this site visit program, groups on average of 15 to 20 OPQ staff--who have experience in a variety of backgrounds, including science, medical, statistics, manufacturing, engineering, and testing-- will observe operations of commercial manufacturing, pilot plants, and testing operations over a 1- to 2-day period. To facilitate the learning process for OPQ staff, overview presentations by industry related to drug development and manufacturing may be provided, which may allow the participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes. OPQ encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to respond. However, please note that this site visit program is not intended to supplement or replace a regulatory inspection, e.g., a preapproval inspection, pre-license inspection, or a surveillance inspection. OPQ staff participating in this program will benefit by gaining a better understanding of current industry practices, processes, and procedures. Although observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ has identified a number of areas of particular interest to its staff. The following list identifies some examples of these areas but is not intended to be exhaustive, mutually exclusive, or to limit industry response:Drug products: [cir] Solutions, suspensions, emulsions, and semisolids; [cir] modified- and immediate-release formulations; and [cir] drug-device combination products (e.g., inhalation products, transdermal products,implants intended for drug delivery, and pre- filled syringes). Active pharmaceutical ingredients manufactured by: [cir] Chemical synthesis; [cir] fermentation; and [cir] biotechnology Design, development, manufacturing, and controls: [cir] Engineering controls for aseptic processes; [cir] novel delivery technologies; [cir] hot melt extrusion; [cir] soft-gel encapsulation; [cir] lyophilization; [cir] blow-fill-seal and isolators; [cir] spray-drying; and [cir] process analytical technology, measurement systems, and real time release testing. Emerging technologies: [cir] Continuous manufacturing; [cir] 3-dimensional printing; and [cir] nanotechnology. III. Site Selection Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility's current compliance status with FDA, and consultation with the appropriate FDA district office. All travel expenses associated with this program will be the responsibility of OPQ; therefore, selection will be based on the availability of funds and resources for the fiscal year. OPQ will not provide financial compensation to the pharmaceutical site as part of this program. IV. Proposals for Participation Companies interested in offering a site visit or learning more about this site visit program should respond by submitting a proposal directly to Janet Wilson (see FOR FURTHER INFORMATION CONTACT). To aid in OPQ's site selection and planning, your proposal should include the following information: A contact person; site visit location(s); Facility Establishment Identifier and Data Universal Numbering System numbers, as applicable; maximum number of FDA staff that can be accommodated during a site visit (maximum of 20); a sample agenda outlining the proposed learning objectives and associated activities for the site visit; number of visits (no more than two) your site would be willing to host by the close of the government fiscal year, September 30, 2018; and months the site is operational that would be ideal for a site visit. Proposals submitted without this minimum information will not be considered. Based on response rate and type of responses, OPQ may or may not consider alternative pathways to meeting our training goals. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26055 Filed 12-1-17; 8:45 am] BILLING CODE 4164-01-P
![57280 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
DEPARTMENT OF HEALTH AND II. The Site Visit Program Æ Continuous manufacturing;
HUMAN SERVICES In this site visit program, groups on Æ 3-dimensional printing; and
average of 15 to 20 OPQ staff—who have Æ nanotechnology.
Food and Drug Administration
experience in a variety of backgrounds,
[Docket No. FDA–2017–N–6286] including science, medical, statistics, III. Site Selection
manufacturing, engineering, and
Site Visit Training Program for Office Selection of potential facilities will be
testing—will observe operations of
of Pharmaceutical Quality Staff; commercial manufacturing, pilot plants, based on the priorities developed for
Information Available to Industry and testing operations over a 1- to 2-day OPQ staff training, the facility’s current
period. To facilitate the learning process compliance status with FDA, and
AGENCY: Food and Drug Administration, consultation with the appropriate FDA
HHS. for OPQ staff, overview presentations by
industry related to drug development district office. All travel expenses
ACTION: Notice. and manufacturing may be provided, associated with this program will be the
which may allow the participating sites responsibility of OPQ; therefore,
SUMMARY: The Center for Drug
Evaluation and Research (CDER) in the to benefit by having an opportunity to selection will be based on the
Food and Drug Administration (FDA) is showcase their technologies and availability of funds and resources for
announcing the 2018 CDER Office of manufacturing processes. the fiscal year. OPQ will not provide
Pharmaceutical Quality (OPQ) Staff OPQ encourages companies engaging financial compensation to the
Experiential Learning Site Visit in the development and manufacturing pharmaceutical site as part of this
Program. The purpose of this document of both active pharmaceutical program.
is to invite pharmaceutical companies ingredients (small and large molecules)
and drug products to respond. However, IV. Proposals for Participation
interested in participating in this
program to submit a site visit proposal please note that this site visit program Companies interested in offering a site
to CDER’s OPQ. is not intended to supplement or replace visit or learning more about this site
a regulatory inspection, e.g., a
DATES: Submit either an electronic or visit program should respond by
preapproval inspection, pre-license
written proposal to participate in this submitting a proposal directly to Janet
inspection, or a surveillance inspection.
program by February 2, 2018. See Wilson (see FOR FURTHER INFORMATION
OPQ staff participating in this program
section IV of this document for CONTACT). To aid in OPQ’s site selection
will benefit by gaining a better
information on what to include in such and planning, your proposal should
understanding of current industry
proposals. include the following information:
practices, processes, and procedures.
FOR FURTHER INFORMATION CONTACT: Although observation of all aspects of • A contact person;
Janet Wilson, Center for Drug Evaluation drug development and production
and Research, Food and Drug • site visit location(s);
would be beneficial to OPQ staff, OPQ
Administration, 10903 New Hampshire has identified a number of areas of • Facility Establishment Identifier
Ave., Bldg. 75, Rm. 4642, Silver Spring, particular interest to its staff. The and Data Universal Numbering System
MD 20993–0002, 240–402–3969, email: following list identifies some examples numbers, as applicable;
CDEROPQSiteVisits@fda.hhs.gov. of these areas but is not intended to be • maximum number of FDA staff that
SUPPLEMENTARY INFORMATION: exhaustive, mutually exclusive, or to can be accommodated during a site visit
I. Background limit industry response: (maximum of 20);
• Drug products:
A critical part of the commitment by • a sample agenda outlining the
Æ Solutions, suspensions, emulsions,
CDER to make safe and effective high- proposed learning objectives and
and semisolids;
quality drugs available to the American Æ modified- and immediate-release associated activities for the site visit;
public is gaining an understanding of all formulations; and • number of visits (no more than two)
aspects of drug development and the Æ drug-device combination products your site would be willing to host by the
drug’s commercial life cycle, including (e.g., inhalation products, transdermal close of the government fiscal year,
the variety of drug manufacturing products,implants intended for drug September 30, 2018; and
operations. To support this delivery, and pre-filled syringes). • months the site is operational that
commitment, CDER has initiated • Active pharmaceutical ingredients would be ideal for a site visit.
various training and development manufactured by:
programs including the 2018 Æ Chemical synthesis; Proposals submitted without this
Experiential Learning Site Visit Æ fermentation; and minimum information will not be
Program. This site visit program is Æ biotechnology considered. Based on response rate and
designed to offer experiential and • Design, development, type of responses, OPQ may or may not
firsthand learning opportunities that manufacturing, and controls: consider alternative pathways to
will provide OPQ staff with a better Æ Engineering controls for aseptic meeting our training goals.
understanding of the pharmaceutical processes; Dated: November 29, 2017.
industry and its operations, as well as Æ novel delivery technologies;
Leslie Kux,
the challenges that impact a drug’s Æ hot melt extrusion;
developmental program and commercial Associate Commissioner for Policy.
sradovich on DSK3GMQ082PROD with NOTICES
Æ soft-gel encapsulation;
life cycle. The goal of these visits is to Æ lyophilization; [FR Doc. 2017–26055 Filed 12–1–17; 8:45 am]
provide OPQ staff exposure to the drug Æ blow-fill-seal and isolators; BILLING CODE 4164–01–P
development and manufacturing Æ spray-drying; and
processes in industry; therefore, a tour Æ process analytical technology,
of pharmaceutical company facilities in measurement systems, and real time
operational status is an integral part of release testing.
the experience. • Emerging technologies:
VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 9990 E:\FR\FM\04DEN1.SGM 04DEN1](https://thefederalregister.org/doc/82_FR_57511/page/1.svg)
Document Created: 2017-12-02 00:41:26
Document Modified: 2017-12-02 00:41:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either an electronic or written proposal to participate in this program by February 2, 2018. See section IV of this document for information on what to include in such proposals. | |
| Contact | Janet Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240- 402-3969, email: [email protected] | |
| FR Citation | 82 FR 57280 |
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