Market Complaint Investigation and Recall
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This document discusses market complaints, product recalls, and complaint handling procedures at Simpex Pharma Pvt. Ltd. It defines complaints and explains the need for an effective complaint handling system. Complaints are classified into types A, B, and C based on severity. The complaint handling process involves receiving, investigating, taking corrective actions, and providing feedback to customers. It also defines and classifies product recalls based on health hazard. The duration and types of recalls - voluntary vs forced - are explained. The document states that the Head QA will decide on recalls in consultation with management and key personnel based on defect category.
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Market Complaint Investigation and Recall
- 1. MARKET COMPLAINTS INVESTIGATION AND RECALL DHANJAY KUMAR SINGH (Sr. Executive QA) SIMPEX PHARMA PVT. LTD., KOTDWAR
- 2. 2 MARKET COMPLAINTS INTRODUCTION A complaint is an objection to something that is unfair, unacceptable, or otherwise not up to normal standards. Complaints may be about Services, Delivery, Quality of Product, Communication, Response, Time, Documentation, Billing, Follow up etc. Complaint is any communication written or verbal, received directly from any customer, retailer, distributor, or representative of contract giver, regarding the quality attributes, labelling defects or any other matter such complaints shall be considered as market complaints.
- 3. 3 Handling of Product Complaints Section 820.3(b) of the Quality Systems regulation defines a complaint as "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”. We (Simpex) define complaint as – “any written or verbal communication received from any customer including qualified personnel, pharmacy, retailer, distributor, or regulatory authorities regarding the purity, safety, strength, efficacy, labeling, shortage or any other issue which claim to be related to the quality of the product/packing in the opinion of the complainer”.
- 4. 4 Why do customers complain? Their expectations have not been met…! When the customer pays for a product or service, it is assumed that the product will work correctly or that the service received is as promised. Ideally, the customer will be satisfied, and there will be no complaints.
- 5. 5 It gives the company an opportunity to improve the quality of the product It is helpful to maintain cGMP It maintains committed relationship between the customer and company It is the regulatory obligation. NEED FOR COMPLAINT HANDLING SYSTEM
- 6. Classification of complaints A-Type Complaints Critical complaints in which product is required to be withdrawn from the market. (Primary Response shall be given within working hours of same day of the receipt of market complaint) Such as • Adverse Drug Reaction. • Major health hazard causing permanent deficiency or death. • Purity & Safety. • Potency. • Product Stability
- 7. Classification of complaints B-Type Complaints Major complaints (Primary response to Major defects shall be given within 24 hours of the receipt of the market complaint) such as • Problem with primary packaging of the product. • Chemical / Physical attributes of the product. • Extraneous contamination, mix-ups, etc.
- 8. Classification of complaints C-Type Complaints Minor complaints (Primary response to Major defects shall be given within 72 hours of the receipt of the market complaint) such as • Problem related to labelling / coding of batch details. • Shortages. • Secondary packaging material problem, etc.
- 9. 9 ComplaintsHandling STEPS INVOLVED IN HANDLING OF COMPLAINTS Step I: Receiving Step II: Investigation Step III: Corrective Actions Step IV: Feedback to Customers
- 10. 10 Complaint flow at manufacturing unit … Reporting Track action Acknowledgment Team formation Investigation Sample check Record review Machine review Expert advice Action Investigation report Response
- 11. 11 PRODUCT RECALL What is PRODUCT RECALL?
- 12. 12 PRODUCT RECALL Recalls are actions taken to remove a product from the market and restrict further distribution and sale – Simpex (SQA013) A recall is when a product is removed from the market… because it is either defective or potentially harmful. – US FDA Permanent removal of therapeutic goods from supply or use for reasons relating to deficiencies in the quality, safety or efficacy of goods. – Therapeutic Goods Administration, Australia
- 13. 13 PRODUCT RECALL There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective. – WHO In order to protect public health… necessary to implement urgent measures such as the recall of one or more defective batch(es) of a medicinal product from the market. – European Medicines Agency (EMA)
- 14. 14 RECALL CLASSIFICATION Class 1 Recall Situation in which there is a reasonable probability that the use or exposure to the product will cause serious adverse health consequences or death.
- 15. 15 RECALL CLASSIFICATION Class 2 Recall Situation in which use or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- 16. 16 RECALL CLASSIFICATION Class 3 Recall Situation in which use or exposure to the product is not likely to cause adverse health consequences.
- 17. 17 DURATION OF RECALL OPERATION Class 1 Recall – Within 24hr to Maximum 72 hr. Class 2 Recall – Within 10 days Class 3 Recall – Within 30 days
- 18. 18 TYPE OF RECALL VOLUNTARY RECALL: This is recall of product from the market or distribution network of entire available quantity at the time of initiation of recall, based on decision by Recall Management Committee. This could be because of: quality complaint from market, or discovery of some deficiency, or stability problem subsequent to dispatch, or unsold stocks (short expiry) FORCED RECALL: This is recall forced by a regulatory agency upon discovery / reporting of violation or deficiency in the product.
- 19. 19 PRODUCT RECALL WHO WILL INITIATE THE RECALL?
- 20. 20 PRODUCT RECALL Head QA shall take the decision on recall in consultation with management of firm including key personnel involved in handling of recall, based on category of defects identified in product/batch(es). In Case of filed products, Head – QA shall consult Head-Regulatory Affairs on the recall strategy, which shall include: Decision to recall Need to inform Marketing, Regulatory bodies and Customers, Extent of effectiveness checks for recall (whether all consignees are to be notified) In case of domestic product recall, the local FDA shall be informed depending on the class of recall.
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