2011-1437. Guidance for Industry on Process Validation: General Principles and Practices; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Process Validation: General Principles and Practices.” This guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements. This guidance revises and replaces the guidance for industry entitled “Guideline on General Principles of Process Validation,” dated May 1987.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian Hasselbalch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4364, Silver Spring, MD 20993-0002, 301-796-3279; or

Grace McNally, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374, Silver Spring, MD 20993-0002, 301-796-3286; or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210; or

Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8268.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Process Validation: General Principles and Practices.” This guidance document provides guidance to the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including APIs.

This guidance describes process validation activities in three stages:

• In Stage 1, Process Design, the commercial process is defined based on knowledge gained through development and scale-up activities.
• In Stage 2, Process Qualification, the process design is evaluated and assessed to determine if the process is capable of reproducible commercial manufacturing.
• In Stage 3, Continued Process Verification, ongoing assurance is gained during routine production that the process remains in a state of control.

In addition to discussing activities typical of each stage of process validation, the guidance provides recommendations regarding appropriate documentation and analytical methods to be used during process validation.

In the Federal Register of November 18, 2008 (73 FR 68431), FDA announced the availability of a draft guidance of the same title and gave interested persons the opportunity to submit comments by January 20, 2009. In the Federal Register of February 13, 2009 (74 FR 7237), the Agency reopened the comment period to March 16, 2009. The Agency received public comments from a broad spectrum of the pharmaceutical industry. In response to comments received on the draft guidance, the Agency added a glossary of terms and clarified or added more specific guidance on certain issues.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the general principles and practices of process validation. 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. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information requested in the guidance are covered under FDA regulations at 21 CFR part 211, 21 CFR 314.70, and 21 CFR 601.12 and are approved under OMB control numbers 0910-0139, 0910-0001 and 0910-0338, respectively.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​AnimalVeterinary/​GuidanceComplianceEnforcement/​GuidanceforIndustry/​default.htm,, or http://www.regulations.gov.

Dated: January 19, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.