PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM: A REVIEW

  • Shrey Sharma
  • R. B. Bodla
  • Shweta S.
  • D. P. Pathak

Abstract

ICH is “International Conference on Harmonization” of technical requirements for registration of pharmaceuticals for human use. The goal of ICH is to discuss and establish common guidelines by bringing together three ICH regions i.e. USA, Japan and EU and to make information available on ICH, its activities and guidelines. The guidelines have become more relevant for Generic’s Drug Approval. Drug Development and manufactures are more and more global. Harmonization is considered more important than ever, as it facilitates work sharing, efficient use of resources and access to medicines. The objective of harmonization is meant for economical use of human, animal and other resources and the elimination of unnecessary delay in the global development and of availability of new medicines whilst maintaining safeguards on quality, safety and efficacy.


The present discussion of the review is on ICH guidelines for quality control focussing mainly on Quality Risk Management (Q9). Quality control is a process that is used to ensure a certain level of quality in a product or service. It might include whatever action a business deems necessary to provide for the control and verification of certain characteristics of a product or service. Most often, it involves thoroughly examining and testing the quality of products or the results of services. The basic goal of this process is to ensure that the products or services that are provided meet specific requirements and characteristics, such as being dependable, satisfactory, safe and fiscally sound.


Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. Two primary principles of quality risk management are:


  • The evaluation of the risk to quality should be based on scientific knowledge and

Ultimately linked to the protection of the patient; and


  • The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.

Keywords: Quality Risk Management (Q9), ICH, Quality risk management.

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References

1. Mario Chen. Brief Introduction to the ICH Guidelines. Family Health International Biostatistics Workshop [Internet].India; 2007 March [cited 2014 July 15]. Available from:
www.icssc.org/Presentations/NewDelhi2007/3BriefIntrototheICHGuidelinesIndia2007.pdf
2. Guidance for Industry-Center for Drug Evaluation and Research. [Internet] Fishers Lane, Rockville: FDA; 2006 June [cited 2014 June 02]. Available from:
http://www.fda.gov/cder/guidance/index.htm
3. Stamatis D H. FMEA from Theory to Execution, 2nd ed. ASQ Quality Press; 2003. p.391-400, ISBN 0873895983.
4. Roberts P. FMECA [Internet].UK: FMECA; 2007 Jan [cited 2014 July 2]. Available from:
www2.warwick.ac.uk/fec/sci/wmg/ftmsc/modules/modulelist/peuss/slides/section_12a_fmeca_notes.pdf.
5. FTA - Fault tree analysis, 2nd ed. IEC 61025 [Internet]. 2006 [cited 2014 July 7]. Available from:
webstore.iec.ch/preview/info_iec61025%7Bed2.0%7Den_d.pdf.
6. Methodology to pharmaceuticals, Annex-7: Application of Hazard Analysis and Critical Control Point (HACCP). WHO Technical Report. S. No. 908; 2003.
7. Safety aspects - Guideline for their inclusion in standards-2014, no. 51-ISO/IEC Guide [Internet]. 2014 [cited 2014 July 27]. Available from:
www.iso.org/obp/ui/#iso:std:iso-iec:guide:51:ed-3:v1:en.
8. Thrussell IR. Quality Risk Management and its application in sterile processing. WHO [Internet]. WHO; 2009 Nov [cited 2014 July 11]. Available from:
apps.who.int/prequal/training resources/3-3_Risk_ Management.ppt
9. Risk management - Vocabulary - Guidelines for use in standards-2009, no.73-ISO/IEC Guide. [Internet]. ISO; 2009 [cited 2014 July 27]. Available from:
www.iso.org/obp/ui/#iso:std:iso:guide:73:ed-1:v1:en.
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How to Cite
Sharma, S., R. B. Bodla, S. S., and D. P. Pathak. “PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM: A REVIEW”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 3, Feb. 2018, pp. 67-78, doi:10.22270/ijdra.v2i3.144.