[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Pages 59298-59299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0365]


Draft Guidance for Industry on the Use of Mechanical Calibration 
of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the

[[Page 59299]]

availability of a draft guidance for industry entitled ``The Use of 
Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good 
Manufacturing Practice (CGMP).'' The draft guidance is intended to aid 
drug manufacturers and ancillary testing laboratories in using 
mechanical calibration as an alternate approach to the use of 
calibrator tablets in calibrating an apparatus used for dissolution 
testing. The guidance provides references to information on critical 
tolerances that should be achieved with mechanical calibration.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 17, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Albinus D'Sa, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-9044.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 
and 2 - Current Good Manufacturing Practice (CGMP).'' FDA regulations 
require that laboratory apparatus be calibrated at suitable intervals 
in accordance with established written specifications (21 CFR 
211.160(b)(4)). Historically, both chemical and mechanical means have 
been used in calibrating dissolution apparatuses. Since 1978, chemical 
calibration has been the predominant method of calibration, consistent 
with chapter 711 of the U. S. Pharmacopeia (USP), which describes the 
use of calibrator tablets. Chemical calibration of an apparatus is 
usually performed, in addition to mechanical calibration, every 6 
months. Because the use of USP chemical calibration tablets can lead to 
variability in the dissolution measurement system, FDA is providing 
guidance on mechanical calibration as an alternate approach to 
calibrating dissolution equipment. As stated in the draft guidance, 
instead of using an external calibrator tablet, a firm can use an 
appropriately rigorous method of mechanical calibration as an 
alternative to ensure ongoing acceptability of the dissolution 
apparatus.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the use of 
mechanical calibration of dissolution apparatus 1 and 2 as related to 
CGMP. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20664 Filed 10-18-07; 8:45 am]
BILLING CODE 4160-01-S