Handling of Market Complaints in Pharmaceutical Industry: A Review

Authors

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

Keywords:

Market Complaints

Abstract

Pharmaceutical products lunch to the market can receive a “Market Complaint” by the customer to the manufacturer via mode of complaint registration, if the product does not meet the defined registered requirements.1-4

Pharmaceutical products are considered of high quality requirements, due to use of the product by patient and are likely to have a serious and fatal impact on the patients, hence the product is been reviewed for quality, identity, purity and/ or safety and are likely to have a serious and fatal impact on the patients.10

Handling of the Market complaint is the responsibility of the Quality Assurance department and hence a strong quality assurance team needs to be present at plant to handle such issues.3&7

In this review article, we have tried to address the important aspects of market complaints, its various types, its handling, and investigation and reporting. Market Complaints are classified into following categories to facilitate the investigation:1&10

Minor Market Complaints: The Complaints indicating no significant impact on product quality, identity, purity and safety is categorized under minor complaints.

Major Market Complaints: The Complaints indicating impact on product specification, identity, purity and safety are categorized under major complaints.

Critical Market Complaints: The Complaints indicating significant impact on product quality, identity, purity and safety and are likely to have a serious and fatal impact on the patients are categorized under critical complaints.

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.
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. Therapeutic Good Administration (TGA) Guidelines:
ICH Topic Q 7 Good Manufacturing Practice for Active
Pharmaceutical Ingredients - Note for Guidance on
Good Manufacturing Practice for Active Pharmaceutical
Ingredients (CPMP/ICH/4106/00). Available from:
http://www.ema.europa.eu/docs/en_GB/document_
library/Scientific_guideline/2009/09/WC500002825.
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. Medicine Control Council (MCC) Guidelines: Guideline
for Recall / Withdrawal of Medicines, Medical Devices
and IVDs. 2015. Available from: http://www.mccza.
com/documents/2f983a705.07_Recalls_Aug15_v4_
for_comment.pdf.
9. 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.
10. Health Sciences Authority - Health Products Regulation
Group: Guidance Notes on Product Quality Review -
January 2013, REFERENCE PIC/S PE 009-10. Effective 01
January 2013. Available from: http://www.hsa.gov.sg/
content/dam/HSA/HPRG/Manufacturing_Importation_
Distribution/Overview_Framework_Policies/GUIDEMQA-
024-004.pdf.

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Published

2019-02-23

How to Cite

Pandey, A. G. (2019). Handling of Market Complaints in Pharmaceutical Industry: A Review. Journal of Drug Discovery and Development ( ISSN:2581-6861), 2(2), 14-18. Retrieved from https://medicaljournalshouse.com/index.php/JDrug-Discovery-Development/article/view/68

Issue

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

Section

Review Article

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