Customer Complaint Process at any Pharmaceuticals SOP

1.0   PURPOSE:

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

2.0    SCOPE:

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


4.1. All customer complaints related to the
    4.1.1. Product Quality (Appearance, Potency) and
    4.1.2 Product Packing (Primary & Secondary Packing)
      are recorded by Marketing Department in Head Office & Marketing 
      Manager then forwards complaints along with Product Sample in question to Q.A.
      Manager at 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  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


SOP will be reviewed at least annually.

Master File of customer complaint Process
 (Key Performance Indicators)

Access and retrieval time NMT 5Mints.

 Complaint not processed on time.
Reputation in market falls.
Customer complaint should be processed on time.
Inform all department heads and precautionary and control measures should be taken accordingly.
QA Officer/QA Manager