QAS-005 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 221

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

will be responsible for locating and bringing the defective sample/s of the product to the
QC department to trigger the investigative analysis on an immediate basis and for other
necessary actions.
7. Meanwhile, the QA director will immediately pass on the information to the general man-
ager and organize a meeting with the product recall committee to identify the type of
recall. Refer to Annexure II for recall classification.
8. After a tentative conclusion of the type of recall, the QA manager will make entries on
Annexure III (Product Recall Investigation Form II) before the final meeting.
9. Immediately after the tentative disposition, the QA director informs the general manager
and advises an immediate provisional freezing of the relevant stocks at the factory store.
Wholesalers, institutions, pharmacies, distributors, and institutions outside the country
will also be instructed to freeze distribution till further instructions.
10. In the absence of the QA director, the QA manager and the QC director will be responsible
for the recall operation.
11. Meanwhile, the general manager will create a team of marketing personnel to start collect-
ing more information to establish facts on Annexure I (Product Recall Investigation Form
I) for legal and technical actions.
12. For corrective actions, refer to Annexure IV.
13. Immediately after the advice offered by the product recall committee , the QA director will
call a meeting of the managers with the general manager for the final conclusion and cor-
rective actions.
14. The legal advisor of the company may also be contacted for his opinion.
15. The meeting objective will be to reassess the depth of recall or other remedial action in
light of the discussion.
16. If considered appropriate, the general manager will also seek advice from the ministry of
health.
17. The possible decisions may be
i. No recall required.
ii. Recall from stores and distribution agents.
iii. Complete recall up to direct users (the general manager may decide to use radio and
television network, if necessary).
18. The ministry of health and all competent authorities of all countries to which the
product/s may have been distributed will be informed promptly if the product/s are to be
recalled.
19. If the decision is no recall, the marketing director will instruct all the distribution centers
to release the stocks, if not replaced by a new batch by that time.
20. The final meeting of the drug recall committee shall be held at the end to review the case
and the steps taken to avoid a similar complaint in future.

21. If appropriate, the committee shall also decide regarding the appropriate compensation
scheme to be followed.

24.4 documentation
Annexure I

Product Recall Investigation Form I

Annexure II Recall Classification

Annexure III Product Recall Investigation Form II

Annexure IV Corrective Action Form