QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 136

SOP No. QAS-002.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Product Complaints Handling Procedures

21.1 PurPose
To provide written instructions for the handling of product complaints. The procedure is designed
to ensure that all product complaints are properly and adequately evaluated and are answered in a
timely and a professional manner. To ensure that any trend indicating a quality deficiency is noticed
at the earliest opportunity.

21.2 resPonsibility
It is the responsibility of quality affairs director and in his absence the QC director to follow up the
procedure.

21.3 Procedure
Note: All complaints shall be replied within 1 week after initial investigation. The investigation
must be concluded within 30 days of the receipt of the complaint. In case where the investigation
cannot be included within the prescribed time because of some legitimate and justifiable reason/s
(including and not limited to: complaint sample not arranged, testing not conclusive, requires repeat
testing, etc.) Attachment QAS-040-VI will be raised by the QA director extending the period of
investigation further to a maximum of 30 days to conclude the investigation and draft a response for
the approval of company's head, if required.

1. All product complaints from each and every source external to the ABC Pharmaceutical
Company are to be passed to the QA director. Complaints may be received concerning the
quality of products from any source. The QA director will forward the complaint with
specific remarks as appropriate for investigation. Complaints may be received from the
following possible routes.

a. Marketing department or sales representatives. For clarity of work, the complaints from

marketing and sales shall come on the enclosed form “Customer Quality Complaint
Sheet,” Attachment QAS-040-I.

b. Regulatory affairs, via letter, fax, or telephone call from customer or the health

authority.

c. Complaints received from all sources including marketing department are to be

assigned a complaint reference number by the QA department (Attachment QAS-
040-II: Product Complaint Receipt Form).

d. A register will also be maintained by the QA to maintain a complaint reference num-

ber to all the complaints in sequential order for the year.

2. Prior to any investigation, analysis and reviews for establishing the validity of the com-
plaints, the possible nature of the complaint will be categorized or classified as critical,
major, or minor on the basis of the enclosed format Attachment QAS-040-III “Complaint
Classification Form.”

3. If assistance is required to evaluate the complaint, a meeting will be called by the QA
director.

4. After identification of the problem, the investigational work will be carried out.