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 submits official comments when we can provide that scientific/technical input.
The World Health Organization (WHO) has released for public comment Part 2 of the Good Manufacturing Practices for Heating, Ventilation, and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms.
ISPE plans to comment on Part 2 and welcomes input from our Members. If you would like to submit comments for consideration, please use the WHO comment template and submit your comments to firstname.lastname@example.org by close of business on Thursday, 5 April 2018.
WHO Document WHO Commenting Template
- Comments should provide technical, scientific feedback to help the agency improve the document, and must include sound justification for any suggested change(s). Language appropriate for a business interaction should be used.
- Comments must be specific and include language that could be substituted for what the regulators propose. For example, a comment of “This is unclear” without providing an explanation and proposed replacement language will generally be eliminated.
- Comments should be limited to what is in contained in the document and should not introduce additional regulations to the document. Comments proposing additional regulations will be eliminated from consideration.
- If the guidance is a revision to a current guidance, focus comments on the new items in the regulation/ guidance rather than on the existing sections that remain unchanged (applies to documents which have been previously released by the agency). This is generally most relevant for EMA publications.
- Identify either the line or section on which you are commenting. In most cases the comment template will provide the structure.
- Provide the information requested in each column of the comment template. Comments lacking any requested information will be eliminated from consideration.
- If the incorrect grammar in a document could result in a misinterpretation of the requirements, then please note it. If not, and if there are many grammatical errors, a single suggestion that the “…grammar should be reviewed and edited as necessary prior to issuance of the final document” is an appropriate comment to be made one time.
- When making reference to other regulations/guidance, be specific and provide the official title and publication date where relevant either within the text or as a footnote.
- Avoid comparing the document under consideration to a similar one published by another regulatory authority. While this is important to do internally within a company, it’s not generally met with any favor by the regulatory authorities.
- Check and correct grammar, punctuation and spelling before submitting for review. Comments should be publication-ready when you are done.
For more information or to suggest a document for comment, contact email@example.com.
ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC). The Regulatory Quality Harmonization Committee welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE.
- The Regulatory Quality Harmonization Committee determines whether the document falls within the scope of ISPE commentary
- A team of subject matter experts are convened to lead the comment development
- Final comments are vetted by ISPE regulatory leadership prior to submission
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