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. Commenting opportunities are listed below.
Focused stakeholders’ consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Deadline: 28 February 2019
The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonized approach to the inspection, including reporting in regard to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.
The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.
ISPE is one of four professional or trade associations selected to collect and compile responses.
To provide feedback on the document, send the template below with the subject line "PIC/S Focused Public Consultation – Data Management and Integrity" to email@example.com by close of business on 28 February 2019. All feedback must be received in the dedicated template for consideration.
Guidance Document 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 firstname.lastname@example.org.
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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