2004D-0443 - Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
FDA Comment Number : EC2
Submitter : Dr. Stephan Roenninger Date & Time: 11/10/2004 04:11:04
Organization : F. Hoffmann-La Roche
Drug Industry
Category :
Issue Areas/Comments
We have only some minor comments on this document:
Lines 167ff: We propose to reword this chapter according to the risk management terms used in the current ICH Q9 draft:
"The concept risk management is a major focus of the Pharmaceutical CGMPs for the 21st Century Initiative. Quality risk management can guide the setting of specifications and critical process parameters. Risk assessment tools are used in determining the need for discrepancy investigations and corrective action. As risk assessment tools can be 6 used more formally by manufacturers and authorities, it can be implemented within the quality system framework."
Foodnote 6
propose to reword as:
"This concept is being developed under the ICH Q9 Quality Risk Management Expert Working Group."
Line 390-393:
The requirement to use "a formal quality planning process" as well as the requirement of "measurable goals that are monitored regularly "exceeds the requirements described in ?211.22 (c-d), 211.100 (a) and could therefore conflict with the statement of lines 118-119.
Line 451-456:
The resources for people of the Quality Units should be also mentioned.
Line 462-463:
Sentence "Management is also expected to develop cross-cutting groups to share ideas to imrove procedures and processes" should be omitted. It describes too specifically only one way how the expectations could be achieved.
Line 487:
Insert "Periodic" in front of "Evaluation of effectiveness of training"
Line 808:
"...the need to periodically audit the system on a risk based approach.
The scope of the term "entire" could lead to misinterpretation.