ISPE invites its Members to comment on proposed regulations and guidance that affect the bio/pharmaceutical industry.
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.
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.
Chapter 6: Quality Control
Inclusion of a new section on technical transfer of testing methods and other items such as out of specification results.
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.
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 firstname.lastname@example.org
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.