PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 315

Corrective action : Action to eliminate the cause of a detected nonconformity
or other undesirable situation. NOTE: Corrective action is taken to prevent
recurrence, whereas preventive action is taken to prevent occurrence [15].
Microbiological hazard : Any circumstance in the process flow of a nonsterile
pharmaceutical that could cause a microbial contamination event affecting
the quality of the product.
Preventive action : Action to eliminate the cause of a potential nonconformity
or other undesirable potential situation. NOTE: Preventive action is taken to
prevent occurrence, whereas corrective action is taken to prevent recurrence
[15].
State of control : A condition in which the set of controls consistently provides
assurance of continued process performance and product quality [15].
Critical levels : A criterion that separates acceptability from unacceptability.
Process flow diagram : A system representation of the sequence of steps or
operations used in the production, control, and distribution of a pharma-
ceutical product.
Monitoring : The act of conducting scheduled measurement or observation of
a CCP relative to its critical limits. The monitoring procedure must be able
to detect loss of control at the CCP [24].
REFERENCES
1. Global Harmonization Task Force, July 2005, Implementation of Risk Management
Principles and Activities Within a Quality Management System, SG3/N15RB/2005.
Available at http://www.ghtf.org/documents/sg3/sg3n15r82005.pdf. Accessed 2011
Jul 18.
2. Gunter F., Hideki A., March 2008, R8 Implementation of Risk Management Prin-
ciples and Activities Within a Quality Management System GHTF.SG3.N15 N15.
Available at http://www.ghtf.org/meetings/conferences/4thapec/5_APEC_SG3_RM%
20Principles%20within%20a%20QMS%20KL%202008-Gunter%20Frey-Hideki%20
Asai.pdf. Accessed 2011 Jul 18.
3. Potter C. PQLI application of science and risk-based approaches-(Q8, Q9, and Q10)
to existing products. J Pharm Inn April 2009;4:4-23.
4. Bush L., September 2009, Quality Risk Management Demystified at CMC Strategy
Forum. Available at http://biopharminternational.findpharma.com/biopharm/GMPs%
2fValidation/Quality-Risk-Management-Demystified-at-CMC-Strateg/ArticleStandard
/Article/detail/624456. Accessed 2011 Jul 18.
5. Kozlowski S., October 2006, Risk Management for Complex Pharmaceuticals. Avail-
able at http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_6.ppt. Accessed
2011 Jul 18.
6. European Medicines Agency (EMA), January 2007, Report of the CHMP Working
Group on Benefit-Risk Assessment Models and Methods. EMEA/CHMP/1504/2007.
Available at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_
and_procedural_guideline/2010/01/WC500069668.pdf. Accessed 2011 Jul 18.