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The document discusses a risk-based contamination control strategy for manufacturing non-sterile pharmaceutical products, emphasizing the importance of contamination control for patient safety and product quality. It outlines the use of Ishikawa diagrams and FMEA to identify potential contamination sources and assess risks, resulting in the identification of 308 potential root causes. The paper highlights the necessity of proactive measures, including proper facility design, staff training, and effective cleaning protocols, to ensure compliance with GMP principles and maintain product safety.

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SandeshSaraf
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24 views

CCS

The document discusses a risk-based contamination control strategy for manufacturing non-sterile pharmaceutical products, emphasizing the importance of contamination control for patient safety and product quality. It outlines the use of Ishikawa diagrams and FMEA to identify potential contamination sources and assess risks, resulting in the identification of 308 potential root causes. The paper highlights the necessity of proactive measures, including proper facility design, staff training, and effective cleaning protocols, to ensure compliance with GMP principles and maintain product safety.

Uploaded by

SandeshSaraf
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Risk-based contamination control strategy of manufacturing non-

sterile pharmaceutical products


Martina Gjorgjevska*; Angela Nastevska1; Stojne Tanevska1
1Bionika Pharmaceuticals, str. Skupi 57, 1000 Skopje, North Macedonia

Contamination is one of the biggest risks to patients’ The conduction of the risk analysis is done in accordance to ICH Q9: Quality
health and the quality of pharmaceutical products. Risk Management and two tools are used: Ishikawa diagram and FMEA.
According to the new version of Annex 1: Manufacture Ishikawa diagram – The cause-and-effect diagram is a tool we used to identify,
for sterile medicine products, manufacturers of examine and display the possible causes of contamination. With this method we
pharmaceutical products need to develop a illustrated the connection between the risk (contamination) and all the factors
Contamination Control Strategy, by implementing the that contribute to its occurrence.
principles of risk analysis, the critical control points are The identified hazards for the possible occurrence of contamination are then
defined and the effectiveness of undertaken controls analyzed using the tool FMEA (Failure Modes and Effect Analysis). The method
and measures for management of risks associated takes into account the parameters probability of occurrence, severity of the risk
with contamination are analyzed. and the possibility of its detection. The risk class is determined by the value of
The aim of this paper is to present the advantages RPN (Risk Priority Number) which is a numerical value. RPN is determined by
and need for implementation of risk assessment as a the formula:
necessary tool for identifying potential hazards and RPN = probability (P) x severity (S) x detection (D)
risks of contamination and manufacturing a product
that will meet the quality specification.

With Ishikawa diagram eight possible causes of contamination are shown: production process, materials, facility/premises, cleaning, training,
personnel, equipment and environment.

Using the FMEA tool, the root causes that could lead to contamination are analyzed and evaluated. According to their RPN value, the risks are
categorized as low, medium and high risks. Total number of 308 risk were identified. Existing controls for decreasing the risk level are analyzed,
through which the risks are reduced to an acceptable level that ensures that the company proactively prevent the possibility of contamination,
i.e., that safe and efficient products are manufactured in accordance with the GMP principles.

Risk analysis was performed in order to determine the potential


sources of contamination in the production facility and premises o Eudralex, EU Guidelines for Good Manufacturing Practice for
using two tools – Ishikawa diagram and FMEA. Eight main Medicinal Products for Human and Veterinary use. Volume 4, Chapter
2: Personnel; Chapter 3: Premises and Equpment; Chapter 5:
potential causes of contamination have been identified:
Production. Brussels, 2014. Available at:
production process, materials, facility/premises, cleaning,
https://health.ec.europa.eu/medicinal-products/eudralex_en
training, personnel, equipment and environment.
o Eudralex, EU Guidelines for Good Manufacturing Practice for
The risks were analyzed with FMEA and 308 potential root Medicinal Products for Human and Veterinary use. Volume 4, Annex
causes were identified. Measures for proactive prevention of 1: Manufacture for Sterile Medicine Products. Brussels, 2008.
contamination have been established, i.e. it is necessary that Available at: https://health.ec.europa.eu/medicinal-
the facility and premises are well designed and constructed for products/eudralex_en
their indented activities, the company has well-trained stuff, o ICH Harmonized guideline Q9 on Quality Risk Management,
good design and maintenance of the HVAC system, cleaning International Council for Harmonisation of Technical Requirements for
validation is performed, the process of flow of materials is well Pharmaceuticals for Human Use, January 2006, Available at:
established, as well that there is adequate documentation for all https://ich.org/page/quality-guidelines
activities that guarantee safe and efficient product.

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