7/18/2021 SOP for Product Recall : Pharmaceutical Guidelines

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SOP for Product Recall

Standard operating procedure to recall the product from the market due to any problem in batch.

1.0 PURPOSE
To provide guidelines to deal with the recalls, field corrections, market withdrawals and stock recoveries.

2.0 SCOPE
This SOP is applicable to the withdrawal of the product from the market.

3.0 RESPONSIBILITY
3.1 Executive Director: For Approval of recall.

3.2 Site Quality Head: For investigation and recommendation for recall. He will notify such recalls to Drug Control Authorities.

3.3 Head of Manufacturing: To investigate the reasons jointly with Site Quality Head.

3.4 Head of Marketing: To monitor and follow up the recalls.

4.0 ACCOUNTABILITY
4.1 Head Quality Assurance

5.0 PROCEDURE:
5.1 Any product complaint from consumer, field staff or from Drug Control Authority is referred to Quality Assurance for investigation.

5.2 After completion of investigation and evaluations QA Manager shall be informed to initiate the recall.

5.3 Based on evaluation the class of recall will be decided.

5.4 Notification to Quality Head shall include the following information:

(a) Complete identity of the product and accurate explanation of the reasons for taking the action.

(b) Date of the action to be completed.

(c) Evaluation of the potential risks.

(d) Quantities of the product for recall.

(e) Level of recall.

(f) Extent of Drug Control involvement.

(g) Any special problems, considerations, complexities etc.

(h) Financial implication of action.

(i) Recommendation for preventive action.

5.5 Site Quality Head will notify local Drug Control Authorities in case of level of recall is of type I or II or recalls initiated on instruction / advise from
Drugs Control Administration.

5.6 Head of Marketing and Distribution shall be informed about the recall and necessary product information. He will stop further distribution and give
clear directions to this effect to all key points in the distribution.

5.7 Recall communication shall also seek and obtain information on stocks of product which is being recalled and confirmation that further distribution
and or sale has been stopped and such stocks are quarantined, by deputing a person to all depots, stockist, chemists& hospitals depending upon the
level of recall.

5.8 If the product defect is CLASS I, the drug has to be withdrawn by sending, intimation up to customer level by making the public announcement
using media and memorandum to all Distributors, Stockist & Hospitals, Chemists and Customers, if addresses available with the bill.

5.9 Head of Marketing / Distribution will check whether the information has reached to all concerned by making telephone or personnel visits to
concerned locations.

5.10 If the product defect is CLASS II, intimation has to be sent to distributors and field staff. Distributors are asked to discontinue the sale of the
product batch. All the field staff shall be informed to collect the stocks concerned from Hospitals / Chemists / Dealers under their area and to return
the withdrawn stocks to concerned distribution center.

5.11 If the product defect is CLASS III, recall the product from distribution outlets and stockiest.

5.12 Entire stocks of the material, which have to be recalled, shall be collected to Warehouse and shall be held under strict security.

5.13 Where appropriate, stocks shall be held till inspection formalities by Drug Authority / Insurance company / Excise authority are completed.

5.14 Site Quality Head shall instruct the Warehouse Manager where the material has to be transferred for disposal.

5.15 Destruction shall be carried out under the supervision of production and QA department representatives.

5.16 Records of such destruction shall be maintained for a period six months beyond the stated expiry date.

6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure

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7/18/2021 SOP for Product Recall : Pharmaceutical Guidelines

6.2 QA: Quality Assurance

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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