ISPE Invites Your Comments

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As an ISPE Member, you can participate in the creation of science-based regulations and guidelines.

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE is the neutral organization through which industry and global health organizations collaborate to improve product quality and patient health.

When ISPE plans to comment on a new or revised regulation or guidance, invitations to submit comments are sent to Members of relevant COPs and posted below. Prior to submission, the comments are vetted by industry SMEs and/or the Regulatory and Compliance Committee (RCC), and ISPE Regulatory Advisors.

Current Commenting Opportunities

ISPE invites comments on the following:

Regulatory Body Document Comments due to ISPE
EC EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation 8 April
FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics 22 April

ISPE is not planning to submit comments on the following, however; Members may wish to comment through their companies:

Regulatory Body Document
WHO General Guidance On Variations To Multisource Pharmaceutical Products
WHO General Guidance On "Hold-Time" Studies Rev. 2
WHO Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format

EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation

The EU published Annex 15, Qualification and Validation, for consultation on 6 February, 2014. The current Annex 15 published in 2001. Since that time the concepts of quality systems, risk management, QbD, and overall changes to the concept of “validation” have been made within the industry. The draft revisions are meant to incorporate these concepts and bring the expected practices up to date with the current regulatory and compliance environment. Annex 15 addresses equipment qualification, process validation, packaging validation, cleaning validation, and verification with regard to transportation. Process validation has been expanded to include the concepts of a life-cycle approach, ongoing process verification and continuous process verification as well as options to blend the traditional approaches with those that are new.

Please submit comments to ISPE by 8 April using the commenting form provided below.

Email the commenting form to regulatorycomments@ispe.org

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FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

This revised draft guidance supersedes the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and, when finalized, will also replace the 1987 FDA guidance for industry on “Submitting Samples and Analytical Data for Methods Validation.” This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

Please submit comments to ISPE by 22 April 2014 using the commenting form provided below.

Email the commenting form to regulatorycomments@ispe.org

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Last Update: 05 June 2013

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