ISPE Invites Your Comments

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ISPE invites its Members to comment on proposed regulations and guidance that affect the bio/pharmaceutical industry.

Current Commenting Opportunities

European Commission Revisions to EU GMP Chapters 3, 5, 6, and 8

Chapter 3: Premises & Equipment
The only change is to section 6, as part of the improved guidance on prevention of cross-contamination, and is also addressed in Chapter 5.  Includes reference to the draft toxicological assessment guidance.

• Download Chapter 3 ( 53 KB)
• Download Chapter 3 commenting form ( 53 KB)

Chapter 5: Production
Changes have been made to sections 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to the draft toxicological assessment guidance. Changes were also introduced in sections 26 to 28 on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorization holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Section (33) is inserted to clarify and harmonize expectations of manufacturers regarding the testing of starting materials, while section (68) introduces guidance on notification of restrictions in supply.

• Download Chapter 5 ( 83 KB)
• Download Chapter 5 commenting form ( 40 KB)

Chapter 6: Quality Control
Inclusion of a new section on technical transfer of testing methods and other items such as out of specification results.

• Download Chapter 6 ( 62 KB)
• Download Chapter 6 commenting form ( 40 KB)

Chapter 8: Complaints, Quality Defects and Product Recalls
Reasons for changes: to reflect Quality Risk Management principles to be applied when investigating quality defects/complaints and when making decisions in relation to product recalls or other risk-mitigating actions; to emphasize the need for the cause(s) of quality defects/complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue; and to clarify expectations and responsibilities in relation to the reporting of quality defects to the Supervisory Authority.

• Download Chapter 8 ( 79 KB)
• Download Chapter 8 commenting form ( 40 KB)

To help you develop your comments, please review the commenting guidelines and example ( 62 KB) .

Note: Chapters 3 and 5 have been expected for some time, and are related to the activity and discussion around dedicated facilities. They should be read in conjunction with the draft EMA Guideline on Setting Health Based Exposure Limits for use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities.

Please submit comments to ISPE by 6 June using the appropriate commenting form provided above. Email the commenting form to regulatorycomments@ispe.org

Commenting Guidelines

• 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.
• Comments need to be meaningful and specific. For example, a comment of “This is stupid” does not meet the criteria and will generally be eliminated from consideration.
• Meaningful comments need to include sound justification for the proposed change as well as specific language that could be substituted for what the regulators propose.
• Be sure the justification and the proposed change are two separate items. Do NOT make regulators search for the information and have to guess at your intent. Comments that do not include a valid justification and proposed change will likely be omitted.
• If the incorrect grammar in a document could result in a misinterpretation of the requirements, then please correct 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.
• Identify either the line or section on which you are commenting. In most cases, the comment template will provide guidance and structure.
• Write clearly and simply. Simple declarative sentences are good. 
• 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 generally not met with favor by the regulatory authorities.
• Check and correct grammar, punctuation and spelling before submitting your comments. Your comments should be publication-ready when you are done.

All comments received by ISPE are reviewed and consolidated by the Regulatory Compliance Committee (RCC). The consolidated comments are then sent to the regulatory body by ISPE President and CEO and posted on the ISPE website. The names of individual contributors are known to the RCC for the purpose of resolving differences of opinion among contributors, however; the names are removed prior to submitting the comments to the authority and posting to the website.