Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology

Upendra Kumar Singh; Sammer Rastogi; Manish Kumar Yadav

Upendra Kumar Singh Lloyd Institute of Management and Technology
Sammer Rastogi Lloyd Institute of Management and Technology
Manish Kumar Yadav Lloyd Institute of Management and Technology

Keywords: Quality risk management (QRM), International Conference on Harmonization (ICH), Failure Modes and Effects Analysis (FMEA), Good Distribution Practices (GDP), Worst potential Effect, Contributory Factors, Rate of severity, Consequences of failure, Probability of occurrence, Rate the effectiveness, Detection Control, Degree of Risk Ranking

Abstract

Quality Risk Management (QRM) is a key component for access the product quality. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of Quality Risk Management (QRM) on the product and process design and its lifecycle. The concept of risk management was first applied in the financial and insurance sectors. This concept was systematically transferred and applied in the pharmaceutical industries in 2005 with the International Conference on Harmonization (ICH) and its publication of the ICH guideline Q9 on “Quality Risk Management”. .

Author Biographies

Upendra Kumar Singh, Lloyd Institute of Management and Technology

School of Pharmacy,
Lloyd Institute of Management and Technology,
Greater Noida, Uttar Pradesh, India

Sammer Rastogi, Lloyd Institute of Management and Technology

School of Pharmacy,
Lloyd Institute of Management and Technology,
Greater Noida, Uttar Pradesh, India

Manish Kumar Yadav, Lloyd Institute of Management and Technology

School of Pharmacy,
Lloyd Institute of Management and Technology,
Greater Noida, Uttar Pradesh, India

References

1. World Health Organization WHO Technical Report series, no. 957, 2010 annex 5 WHO Good Distribution Practices for Pharmaceutical Products
2. Information from European Union Institutions, Bodies, Offices And Agencies European Commission Guidelines, 5 november 2013, On Good Distribution Practice of Medicinal Products for Human Use (text with EEA relevance) (2013/C 343/01)
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Quality Risk Management Q9 Current Step 4 version dated 9 November 2005.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Pharmaceutical Development Q8(R2) Current Step 4 version dated August 2009.
5. EU GMP Guidelines on 19 march 2015 Principle of Good Distribution Practice of active substances for medicinal products for human use.
6. A guide to supply chain risk management for the pharmaceutical and medical device industries and their suppliers v.1.0 2010 the chartered quality institute pharmaceutical quality group website at www.pqg.org.