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DOC-20230517-WA0003. (1)

Complaints

Chandrashekhar3
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DOC-20230517-WA0003. (1)

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  1. Presented By : Akash R. Turaskar Class : 3rd Year 6th Sem Guaided By : Badwaik Sir

  2. Complaints Define:- Complaints is define as statement That is something wrong or not good enough ➢Generally in pharmaceutical industry complaints are related to quality of drug products. ➢Complaints may be about services, delivery, quality of product, communication, response time, documentation, billing, follow up etc. ➢Complaints may be about packaging material such as bottle is leakaging, missing tablet, difficult to open cap,

  3. Sources of complaints • Internal - complaint can be from production quality control workhouse. • External - complaint can be from customer, doctor, clinic, hospitals, pharmacy . Purpose of complaint . ➢ To provide product quality & safety to maintain customer satisfaction Classification of complaints 1. A. type complaint . 2. B. type complaint . 3. C. type complaint .

  4. A- type complaint .( Critical Complaints.) ❖Adverse Drug reaction ❖Major health hazard ❖Purity and safety ❖Potency ❖Product stability B- type complaint. ( Major complaints like.) ❖Problem with primary packaging ❖Any labelling leaflet misinformation ❖Microbial contamination of non sterile product ❖Noncompliance to specifications

  5. C- type complaint .( Minor complaint .) ❖Problem related to labeling/ coding of batch details. ❖Shortages of secondary pack. Responsibility of complaints. ➢Production head ➢Q.A. head ➢Unit head

  6. . Thank You

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