Complaints and recalls

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1 Complaints and Recalls Presented By: Rahul.G.Baraiya (M.Pharm-Q.A,Sem-1) Matushree V.B. Manavar College of Pharmacy ,Dumiyani . Guided By : Mrs.Riddhi Madhu Mr.Suman Acharyya Mr.Vijendra Chauhan

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2 1. Objectives 2. Principle Important Points of Complains: 3. Procedure – I,II,III 4. Classification of Defects

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3 OBJECTIVES -To identify the key issues in product complaint and recall handling -To understand the specific requirements for organization, procedures and resources -To understand and develop actions to resolve current issues applicable to you

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4 Complaints: Principle “All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken.”

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5 Complaints Procedure – I Designated responsible person: To handle complaint Decide on measure to be taken Sufficient support staff Access to records Written procedure (SOP): Describes action to be taken Includes need to consider a recall (e.g. possible product defect)

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6 Complaints Procedure - II Thorough investigation: QC involved With special attention to establish whether "counterfeiting" may have been the cause Fully recorded investigation – reflect all the details Due to product defect (discovered or suspected): Consider checking other batches Batches containing reprocessed product

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7 Complaints Procedure - III Investigation and evaluation should result in appropriate follow-up actions May include a "recall“ All decisions and measures taken should be recorded Referenced in batch records Records reviewed - trends and recurring problems

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8 OTHER ACTIONS Inform competent authorities in case of serious quality problems such as: Faulty manufacture Product deterioration Counterfeiting

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9 Classification of Defects Once defect has been identified, company should be dealing with it in an appropriate way, even recall The following system has been found in some countries (but it is not a WHO guideline): Critical defects Major defects Other defects

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10 Critical Defects Those defects which can be life-threatening and require the company to take immediate action by all reasonable means, whether in or out of business hours Examples Product labelled with incorrect name or incorrect strength Counterfeit or deliberately tampered-with product Microbiological contamination of a sterile product

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11 Major Defects Those defects which may put the patient at some risk but are not life-threatening and will require the batch recall or product withdrawal within a few days Examples Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient Microbial contamination of non-sterile products with some risk for patients Non-compliance to specifications (e.g. active ingredient assay)

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12 OTHER DEFECTS Those defects which present only a minor risk to the patient — batch recall or product withdrawal would normally be initiated within a few days Examples Readily visible isolated packaging/closure faults Contamination which may cause spoilage or dirt and where there is minimal risk to the patient

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13 Important Points of Recall: 2- Principle 1- Reasons for Recall 3- Defination 4- Recall Procedure 5- SOP for Recall

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14 Reasons for Recall Customer complaint Detection of GMP failure after release Request by the national authorities Result of an inspection Known counterfeiting or tampering Adverse reaction reporting

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15 Principle “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.”

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16 Definition Recall Removal from the market of specified batches of a product May refer to one batch or all batches of product

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17 Recall Procedure Designated responsible person (should be the "authorized person") To execute and coordinate recalls Decide on measure to be taken Sufficient support staff To handle all aspects and urgency of recall

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18 SOP for Recall Established, written and authorized Detailed actions to be taken Regularly reviewed and updated Capable of rapid operation to required level of distribution chain, e.g. hospital and pharmacy level Store recalled products in a secure, segregated area

References:

References 1. Sidney H.Willig, Good Manufacturing practices for pharmaceuticals, 5 th edition, pg no.309,310,337. 2. Lachman Leon, Lieberman, Herbert A, Joseph L., kanig ,The theory and practice of Industrial pharmacy, 3’rd edition,Indian edition, published by Varghese Publishing House,Hind Rajasthan Building, Dadar, pg no. 854. 3. http://en.wikipedia.org/ 19

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20 Thank You

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