SOP FOR HANDLING OF COMPLAINTS
1.1 To lay down a procedure for receipt, registration, investigation, resolution, maintenance of records and closure of market complaints received by company for the products sold into the market.
2.1 This procedure is applicable to all the complaint handling practices and activities associated with the complaint intake, processing, evaluations and closure.
3.1QA department is responsible for:
3.1.1 Receipt and registration of market complaints received pertaining to any product.
3.1.2 Investigation of the complaint in co-ordination with respective departments as described in this procedure.
3.1.3 Intimation to the Complainant on initial investigation and subsequent root cause identified and further course of action thereof. Also, intimate customer if there will be an anticipated delay is responding to the complaint.
3.1.4 Closure of the investigation and intimation to the Complainant accordingly.
3.2Head/Designee-QA is responsible for ensuring the implementation of the committed Corrective and Preventive Action (CAPA)within stipulated timeframe.
3.3Head/Designee-QA is also responsible for ascertaining the effectiveness of CAPA implemented.
4.1 Head -QA
5.1Complaints: Complaints are objections, errors, or non-conformities involving product quality, or failures to provide desired services or other requests of the customer or any other reported human health effects in the market.
5.2 Definitions of various classes of complaints are as follows:
5.2.1Critical Complaints: Are those affecting immediate human/public health and those received directly from regulatory agencies.
5.2.2Major Complaints: Are those involving the products supplied to the market, i.e. those not meeting the established quality attributes, stability failures, pilferage during transit, packaging and labeling issues.
5.2.3Minor Complaints: Are those involving logistics, transportation, commercial aspects.
6.1 Head-QA/designee shall directly receive any market complaint from the customer or regulatory agency and immediately proceed with the registration of complaint and begin initial preliminary investigation.
6.2 The complaint shall be logged by Head-QA/designee in the complaint logbook (Annexure-1).
6.3 If any complaint is received via marketing departmentor received by any functional department, it shall be forwarded to Head-QA for immediate registration followed by initial preliminary investigation.
6.4 The mode of complaint received can be any form, viz. verbal, via electronic e-mail from customer/marketing department or in writing from customer/regulatory agency, regarding the poor product quality, or poor services or observable/reported human health effects in the market.
6.5 Complaint shall be classified based on Risk Assessment and shall be prioritized for investigation based on nature/class of complaint received.
6.5.1 Following aspects shall be considered during the classification:
188.8.131.52 Perceived risk of the quality, purity and efficacy of the product,
184.108.40.206 If it affects public/human health
220.127.116.11 Quality of product supplied and
18.104.22.168 Poor quality services rendered.
6.5.2 Based on the above criteria, Head-QA shall classify the complaint into Critical, Major or Minor complaints.
6.5.3 Also, investigation should be prioritized in to High, Medium or Low before commencing the preliminary investigation. This shall be indicated in the priority column of investigation form(Annexure-2).
6.6 Once a complaint is assessed to be “critical” impacting the quality, purity and efficacy of the product, Head-QA shall send immediately an “Initial Alert Report” to the Head-RA with nature and details of this critical complaint.
6.7 Subsequently, Head-QA shall provide a signed detailed investigation report to the Head-RA. As soon as investigationis completed with appropriate CAPA/recall decision etc.
6.8 Head- RA in consultation withTop Management shallinform concerned regulatory agencies ofthe country where the particular productis registered.
6.9 Once thorough investigation is completed and root cause is established with proposed CAPA, the report shall be shared with the agency/customer (as required).
6.10 QA shall assign a unique number to the complaint for life-cycle products.
6.11 QA shall initially acknowledge the complaint to the customer within one working day after logging the complaint.
6.12 Head-QA/Designee shall investigate the complaint with the help of concerned departmental head to find out root cause.
6.13 Depending on the risk assessment and above classification, Head-QA/designee shall carry out preliminary investigation through initiating checks on the control samples of the same batch and analyze the same (if required). Necessary help from PD may be taken if it pertains to stability of a product /material or scientific data needs to be established in laboratoryin connection with the complaint.
6.14 Before proceeding to thorough investigation, QA shall(as required) request the customer to provide photographs, field samples of the batch handled by them, their QA investigation report and observations required to carry out the investigation.
6.15 Investigation can be extended to the other batches through look-back and look-forward concept (minimum 5 batches back and forth from the batch under complaint) as these also might be affected due to the reason of complaint under investigation.
6.16 Head QA/Designee and Head-Production/Designee shall review the batch Production and control Records, analytical records and other related documents thoroughly, to check for any deviations or abnormalities reported or recorded during the manufacturing of the batch under complaint.
6.17 Head-QA/Designee shall evaluate the findings of the investigation and propose CAPA to avoid the re-occurrence of such complaints in the investigation report (Annexure-2). Also evaluate whether voluntary recall of material will be necessary, based on the assessment of investigation report and perceived risk.
6.18 Time limits for Closure of various types of complaints:
6.18.1 Head-QA shall send a written reply to the complainant within the following stipulated period for various category of complaints:
22.214.171.124 For Critical complaints: Within 10 business days (preferably even earlier) if investigation is completed and root cause is established. This has to be considered as “High Priority”.
126.96.36.199 For Major Complaints: Within 15 business days (preferably even earlier) if investigation is completed or root cause is established. This has to be considered as “Medium Priority”.
188.8.131.52 For Minor Complaints: Within 30 business days if investigation is completed. This can be considered as “Low Priority”.
6.19 QA shall distribute the investigation report to the concerned department Head.
6.20 Head-QA shall take the decision of product recall (as assessed after establishing the root cause) as per the Product Recall in consultation with top management.
6.21 QA shall retain all the documents related to the complaints as per the Retention and destruction of document.
6.22QA shall review the complaint records annually and establish co-relation of current complaint with previous complaints of similar nature and record in the concerned Product Quality Review.
6.23 QA shall close the complaint in the following circumstances:
6.23.1 If satisfactory response is obtained from the complainant against written reply received from company.
6.23.2 If the material is recalled voluntarily, company shall follow the procedure as mentioned in the Product Recall.
6.23.3 If the material is returned by the customer inspite of discussions during thorough investigation phase of the complaint, company shall follow the Procedure for Handling of Return Goods.
6.23.4 If no response is obtained from complaint within 30 business days from the date of written response from company.
7.1 QA -Quality Assurance
7.2 CAPA -Corrective and Preventive Action
7.3 RA –Regulatory Affairs
7.4 PD –Product Development
8.0ANNEXURE (Available in Download tab)
8.1 Annexure-1: Complaints Log
8.2 Annexure-2: Investigation report for complaint
END OF THE DOCUMENT
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Last Updated : 07-06-2018 02:21:26 pm
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