Customer Complaints from the Market of Medicine SOP

SOP For handling of Customer Complaints from the Market of Medicine is described in this post which you can follow in the section of the Q.A.

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1. Purpose:

1.1. To ensure timely resolution of product & packaging related complaints received from the market.

2. Scope:

2.1. This procedure is applicable for product & packaging related complaints received by Quality Assurance Department at Pharma Pharmaceuticals

3. Responsibilities:

3.1. Q.A. Manager / Incharge is responsible to investigate all complaints, maintain a record & liaison with Marketing.

3.2. Manager Plant & Production & Manager Q.C. are responsible to assist Q.A. Manager  in investigation of root cause of non-conformance & implementing corrective action.

3.3. Q.A. Officer is responsible to maintain complaint log, complaint related non-conformance report & forward copies of NCR to Marketing.

3.4. Q.A. Manager is responsible to ensure resolving complaints within time limits specified in this procedure.

3.5. Marketing Manager & Manager International Marketing are responsible to forward product complaints in writing along with sample of the product.

4. Procedure:

4.1. All customer complaints related to the

4.1.1. Product Quality (Appearance, Potency) 

4.1.2 Product Packing (Primary & Secondary Packing) are recorded by Marketing Department in PHARMA Head Office & Marketing Manager then forwards complaints along with Product Sample in question to Q.A. Manager at PHARMA Plant..

4.2. Q.A. Manager records the complaint on Non conformance form NCR (F-07-009) to initiate investigation and corrective action.

4.3. Q.A. Manager arranges a meeting with Plant & Production Manager and Q.C. Manager for investigating the root cause of the non-conformance described in customer complaint.

4.4. If required the product is evaluated for appearance & potency against retained product sample of the same batch & screen product batch record.

4.5. Packaging related complaints are evaluated by 

4.5.1. Observing & recording physical condition of sample received & compares it with PHARMA products packing specification.

4.5.2.  Screen batch record to evaluate potential causes of nonconformance during packing operation.

4.5.3  Review material release report from Quality Control.

4.6.  Q.A. Manager after investigation records the root cause & corrective action taken on NCR & forward copies of NCRs to Marketing.

4.7.  Q.A. Department ensures to provide preliminary report to Marketing within 15 days of receiving the complaint.

4.8.  If nature of complaint requires product recall Q.A. Manager recommend Recall to Marketing as per SOP-07-013 (Product Recall).

4.9. Q.A. Manager maintains all complaints record for 2 years from date of complaint received.

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