PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 123

the process is risk communication to concerned personnel to highlight the suc-
cesses and “failures” of the development process so that they may learn from the
collective company experience.
This is not to say that there will not be surprises during technology
transfer—there will be and those will be “risk events” that need to be assessed,
analyzed, and used as feedback to refine the risk assessments and issue new
versions of the batch manufacturing instructions and/or analytical control
procedures or shipping or labeling procedures. Continual improvement is the
final and overriding element in any quality system, so that there is no ultimate
state of “quality” but a constant feedback of knowledge gained to decrease
uncertainty and reduce risk in feedforward.
6.8 SUMMARY
To summarize, the use of risk management tools in process development and
manufacture of clinical trial material allows for increased process understanding.
By identifying (critical) control points and providing clearly defined risk mit-
igation measures, the product control strategy becomes a systematic means of
ensuring product and process consistency. By clearly documenting risks and the
measures implemented to reduce them, risk communication is greatly enhanced.
Personnel involved in the manufacture and quality control of the product can
be provided with clear, written instructions accompanied by focused emphasis
on identified risks. Those areas where there is increased uncertainty because the
risks are not yet clearly understood can also be identified and strategies including
increased sampling and testing may allow increasing the likelihood of detection
of any failures.
Documentation of the risk assessments and their outcomes as well as periodic
updating when new information comes to light ensure life cycle management and
maintenance of the product control strategy and a safe product for participants
in the trials.
REFERENCES
1. ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug
Substances and New Drug Products: Chemical Substances.
2. Chapters 8, 12, and 14 describe and provide examples of CPPs and CQAs.
3. ICH Q10, Pharmaceutical Quality System, June 2008.
4. Eudralex Volume 4, EU GMPs, Chapter 1, Quality Management.
5. US FD&C Act.
6. ICH Q8(R1), Pharmaceutical Development, November 2008.
7. Author's parentheses—this version appeared in the draft Q8 R1 guide, but was elim-
inated from the final version. Nevertheless, it is relevant because the QTPP must be
updated as development progresses.