SOP on Market Complaints

0
10276

Objective
To write a procedure for handling and Management of Market complaints

Scope
All the complaints oral and written Market complaints received.

Responsibility
Head QA,
Head production
Plant head

Procedure
A complaint defines as “dissatisfaction to a particular product”.
This satisfaction communicated by anyone to the organization (manufacturer of that product) by any means, orally, verbally and electronically.

Receiving of complaints

  • Complaints can be received by anyone –customer retailer, patients, doctors, wholesaler etc.
  • Complaints received by any means shall be recorded in log book.
  • To investigate properly, try to get more information about the same, if sample received regarding the complaint it would be a great supporter to investigate the right things.
  • Complaint shall log into QA department, and a written form to be fill, containing information regarding complaint (sample template as per annexure-I)
  • All received complaint when logged and investigate shall assign a number, that no. can be any type, one e.g. MC/XXX/YYYY where:-
    MC for market complaint
    XXX is a sequential year –shall be start from 01, 02, 03….so on
    YYYY represents the year of complaint received E.g. MC/001/2017

Types of complaints
Complaints shall divide into three parts on the basis of criticality:
1. Critical complaints
2. Major complaints
3. Minor complaints

Critical Complaints:
The complaints related to defect in Product quality, i.e., purity, efficacy and safety are known as ‘’Critical Complaints” which may lead to death of patient. e.g.
– Cross contamination of product
– Serious adverse reaction of product
– Products failing in Sterility and Bacterial Endotoxin test

Major Complaints:

The complaints, which lead to major problem in patient’s health because of defect in Product quality i.e. Purity, identity and reliability e.g.
– Settlement of contents
– Loss of potency
– Significant discoloration

Minor complaints:

The complaints related to defect in Product quality, i.e., Durability, filling defects and packing defects, which lead to least problem in patient’s health e.g.
– Filling defects
– Packing defects
– Durability

Review, Investigation, evaluation and closing of complaints

  •  Head QA shall review the complaints and evaluate whether investigation is required or not.
  • If required, Head QA shall investigate the complaints along with HODs of concerned departments
  • All investigated shall be documented and if for history, documents shall review will include in investigation.
  • In case the investigation represents that complaints is serious and affect the Quality, safety or efficacy of the product, a detailed investigation shall be carried out.
  • Detailed investigation includes review of the documents including batch manufacturing record, Testing reports of the concerned batch and if required retesting of the batch by using control sample of the said batch shall be performed.
  • If a product defect is discovered or suspected in a batch, investigation may be extended to other batches, which were manufacture during same time using the same lot of raw material or packaging material and batches which may contain reworks of the defected batch.
  • The stability report with respect to different storage conditions of temperature and relative humidity shall be checked by QA, in case of problems related to loss of potency, significant discoloration, settlement of the contents and other stability related problem in the products.
  • In case detailed investigation is not desired, reason and name of the responsible person, Head QA shall take the decision and close the market complaint with conclusion.
  • After completion of market complaint a conclusion shall be written by head QA and closing of complaints shall be done.
  • Any market complaint received shall be closed within 30 days from receiving the complaint.
  • In case complaint is critical and determined to be serious and unexpected shall taken as soon as early.
  • All the market complaints shall be reviewed in annual product review and a trend of complaints based on types shall be prepared.
  • During investigation, if any recurring evaluated, corrective / preventive actions shall be fixed to prevent.
  • Each complaint shall be retained for a period of at least 5 years from the date of complaint was received.
  • In case of regulatory or export, If the product of same batch is distributed in more than one country and a complaint is received from a country, then status of product in other countries shall also be investigated.

Sample of Annexure:-
1. Log book sample of Market complaint 

S. No. Complaint No. Date of receiving Product Details Type of complaint Complaint’s details Closing Date
   
   
   

 

Related articles

Handling of Pharmaceuticals Market complaints


Notice: compact(): Undefined variable: limits in /home/pharmapathway/public_html/wp-includes/class-wp-comment-query.php on line 853

Notice: compact(): Undefined variable: groupby in /home/pharmapathway/public_html/wp-includes/class-wp-comment-query.php on line 853

LEAVE A REPLY

Please enter your comment!
Please enter your name here