��COMPLAINTS (Complaints & Relevance of Complaints/ Complaining, Types & Evaluation of Complaints)

PHARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

RANCHI – 835215

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LEARNING OUTCOMES

Upon completion of this short presentation, we will be able to,

• Understand the concept of complaints, relevance of complaining.
• Learn about their types and ways of evaluation.

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CONTENTS

• INTRODUCTION TO COMPLAINTS
• TYPES OF COMPLAINTS & IT’S RELEVANCE
• WAYS OF EVALUATION OF COMPLAINTS
• CONCLUSION

INTRODUCTION

WHAT DO WE MEAN BY COMPLAINTS?

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• The concept of Complaint/ Complaining arises when something has gone wrong or perceivably not good enough/ acceptable.
• Additionally, the customer shows his/ her dissatisfaction about the quality of a particular product/ service by criticism, lodging a complaint or by giving feedbacks.

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RELEVANCE OF COMPLAINTS/ COMPLAINING

Meeting customer needs and expectations is the pivotal role any company must play in order to stay competitive in any market. So for that, addressing the customer complaints and feedbacks becomes one of the most important steps as it does the following;

• It gives opportunity to improve quality of the product even more.
• It helps to maintain cGMPs.
• It helps in stringing a committed relationship between customer and the manufacturing company.
• It also fulfils various regulatory obligations.

LET’S RECALL

At this moment, we shall recall whatever we have learnt so far. So, kindly pause the video and try to revisit the things that have been discussed as questions below:

• What is Complaint/ Complaining?
• What is the relevance of complaint/ complaining?

TYPES OF COMPLAINTS

Complaints are of the following types as mentioned below:

1. Quality Complaint – Originates at the consumer level and concerned with the physical, chemical and biological property of the product. For e.g.: condition of packaging/ labelling of product.
2. Adverse Reaction Complaint – Happens due to any allergic or idiosyncratic reaction from the product being used.
3. Medical Complaint – Includes lack of efficacy or any other clinical response.

TYPES OF COMPLAINTS

4. Critical Complaint – Life threatening and require company to take immediate action (even out of business hours). For e.g.; microbiological contamination of sterile product.
5. Major Complaint – Risky at times but are not life threatening and will require immediate batch recall or product withdrawal. For e.g.; microbiological contamination of non-sterile product.
6. Minor Complaint – minor/ no risk to patient; batch recall or product withdrawal would be done if fault is found. For e.g.; packaging/ closure fault.

EVALUATION OF COMPLAINTS

Steps involving handling & evaluation of complaints are as follows:

1. Receiving complaints
2. Technical Investigation
3. Corrective Action & Preventive Action (CAPA)
4. Feedback to customer
5. Monthly Report & Trend Analysis

CONCLUSION

So, as a pharmaceutical professional, avoiding complaints regarding any product or service and maintaining a good reputation and market-share are primary attributes that will ensure customer appeal and satisfaction.

Moreover, interest on future offerings can also be guaranteed based on customer needs which ultimately will trigger a more competitive playing field for like-minded companies who want to create ‘the best product/ service’.

SO, IN THE NEXT VIDEO, WE WILL LEARN ABOUT;

1. What are returned & recalled goods? What are the steps to be taken for handling them?
2. What is Waste Disposal and its types? Explain the process of waste disposal.

Prepared By:��Mr. Anwesh Bhowmick�Dr. Manik Ghosh��PHARMACEUTICAL QUALITY ASSURANCE�DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY�BIRLA INSTITUTE OF TECHNOLOGY, MESRA �RANCHI – 835215