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

1. Volume 4 EU Guidelines for Good Manufacturing
Practice for Medicinal Products for Human and
Veterinary Use - Part 1 Chapter 8: Complaints, Quality
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
veterinary medicinal products Available from: https://
ec.europa.eu/health//sites/health/files/files/eudralex/
vol-4/2014-08_gmp_chap8.pdf.
2. Pharmaceutical Inspection Co-operation Scheme
(PIC/S) - Guide to Good Manufacturing Practice for
Medicinal Products Part I - PE 009-13 (Part I) - 1 January
2017. Available from: file:///C:/Users/mydel/AppData/
Local/Temp/PE_009_14_GMP_Guide_Part_I_Basic_
Requirements_for_Medicinal_Products_.pdf.
3. World Health Organization (WHO): WHO Expert
Committee on Specifications for Pharmaceutical
Preparations - WHO Technical Report Series, No. 908
- Thirty-seventh Report, 2003. 148 pages. Available
from: http://apps.who.int/medicinedocs/en/d/
Js5517e/20.4.5.html#Js5517e.20.4.5.
4. Title 21 - Food and Drugs Chapter I - Food and
Drug Administration Department of Health and
Human services subchapter c--drugs: General -
Part 211 current Good Manufacturing Practice for
Finished Pharmaceuticals. Available from: https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?fr=211.198.
5. Medicines & Healthcare products Regulatory Agency
(MHRA): A Guide to Defective Medicinal Products
- Reporting, Investigating and Recalling Suspected
Defective Medicinal Products. A Guide for Patients,
Healthcare Professionals, Manufacturers and
Distributors. Available from: https://www.gov.uk/
government/uploads/system/uploads/attachment_
data/file/403210/A_guide_to_defective_medicines.
pdf.
6. Saudi Food & Drug Authority - Guide to Good
Manufacturing Practice for Medicinal Products. 2011.
Available from: https://www.sfda.gov.sa/en/drug/
drug_reg/Regulations/SFDA-GMP2018.pdf.
7. International Council for Harmonization (ICH) Guidance:
ICH Q10 Pharmaceutical Quality System. Available
from: http://www.ich.org/fileadmin/Public_Web_Site/
ICH_Products/Guidelines/Quality/Q10/Presentation/
Q10_General_Presentation.pdf.
8. Therapeutic Good Administration (TGA) Guidelines:
Guide to Good Manufacturing Practice for medicinal
products Part I - Guide to GMP for Medicinal Products.
Available from: https://www.tga.gov.au/sites/default/
files/pe009-13-gmp-guide-part1-basic-requirements.
pdf.
9. Medicine Control Council (MCC) Guidelines for Good
Manufacturing Practices (GMP): 4.01 SA Guide to GMP
Jun10 v5. Available from: https://www.sahpra.org.za/
documents/16b9955c4.01SAGuidetoGMPJun10v5.pdf.

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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