Handling of Deviation Control in Pharmaceutical Industry: A Review

Authors

  • Anupam Gulabdhar Pandey Oman Pharmaceutical Products Co. LLC., Raysut Industrial Estate, Salalah, Sultanate of Oman.

Keywords:

Deviation, Deviation Control

Abstract

Deviation: Deviation can be defined as any activity/ event which is in the form of noncompliance from designed standard. Deviation happened in pharmaceutical industries on day to day basis during performing the routine activities.

Various Regulatory health authorizes has defined procedure to address the occurred deviation during the operational activities to understand the impact of deviation on the quality of the products.

Regulation are in place as per the ICH norms to handled the unavoidable circumstances by recording the deviation occurred and thereafter to address the same considering the impact of the same on quality, efficacy and safety of the drug products.

Details below are on deviation controls and its handling methodology to address the issue accordingly.

Planned Deviation: Planned deviation can be defined as activity/ event which is planned in advance/ priory to perform differently against the standard.

Incident/ Unplanned Deviation: An incident can be defined as unplanned or uncontrolled activity/ event in the form of non-compliance from designed standard.

Correction: Repair, rework or adjustment and related to the disposition detected discrepancy/ nonconformance.

Corrective Action: Action taken to rectify or correct a specific deviation or undesirable situation is known as corrective action.

Preventive Action: Action taken to eliminate the cause of deviation or undesirable situation to prevent the future occurrence of similar instances is known as preventive action.

References

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Practice for Medicinal Products for Human and
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Defects and Product Recalls: Legal basis for publishing
the detailed guidelines: Article 47 of Directive 2001/83/
EC on the Community code relating to medicinal
products for human use and Article 51 of Directive
2001/82/EC on the Community code relating to
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Published

2019-02-23

How to Cite

Pandey, A. G. (2019). Handling of Deviation Control in Pharmaceutical Industry: A Review. Journal of Drug Discovery and Development ( ISSN:2581-6861), 2(2), 7-13. Retrieved from https://medicaljournalshouse.com/index.php/JDrug-Discovery-Development/article/view/69

Issue

Vol. 2 No. 2 (2018): Journal of Drug Discovery and Development

Section

Review Article

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