QAS-005 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 220

SOP No. QAS-005.00 Effective date: mm/dd/yyyy
Approved by:

SUBJECT: Product Recall Procedure

24.1 PurPose
To provide written instructions to be followed for prompt action in the event of a minor, major, and
critical complaint which is suspected or known to be a defective or hazardous product.

24.2 resPonsibility
It is the responsibility of directors QA and QC, and the QA manager to identify the basis of recall
in collaboration with the product recall committee. The QA director is responsible for the complete
recall operation.

24.3 Procedure

1. The objective is to establish a procedure that will enable prompt action to be taken to recall
a product that is suspected or known to be defective or hazardous. If recalled, the product
will be kept in a segregated area.

2. The responsibility for identifying the possible need to recall a product also rests with any
member of the management whose knowledge and/or technical training will enable him to
identify that a potentially defective or hazardous product has been supplied to the market
or to a customer. This manager has an immediate obligation to inform the general manager
of his opinions in this matter.

3. The responsibility for initiating a product recall rests with the general manager. To assist
him in discharging this responsibility, he will consider the advice offered by the product
recall committee .

4. The members of the product recall committee are as follows:
• QA director
• Production director
• Materials director
• Marketing director or representative
• QC director
• QA manager
• R&D director
• Any other employee considered resourceful by the committee
• Legal advisor of the company, if considered applicable
• The QA director will identify the scope and nature of the defect or hazard
• The QC director will check the scope and nature of the defect or hazard
• The QA manager will verify the scope and nature of the defect or hazard
• The marketing director will identify the possible market/consumer penetration of
the defective or hazardous product and collect information on relevant forms

5. In the absence of the general manager of the company, the QA director will be responsible
for initiating a product recall.

6. Soon after a complaint is received through any source or management level, it is the
responsibility of the receiver of the complaint to pass the information immediately to the
QA director, QA manager, or QC director, whichever is applicable. The marketing director