Standard Operating Procedure for Product Recall Document Number: C107 Revision Number: 00 Effective Date: 06/15/14 Author: Muna Ali Date: 05/12/14 Author: Sahar Ansari Date: 05/12/14 Approvals: John Smith Date: 06/15/14

SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL

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1. Introduction Product recall is indicated when a product could represent a health risk to the consumer

2. Purpose To provide a documented procedure of handling of product recall

3. Scope This procedure is applicable to recall quality defective drugs when reported incidents of safety and efficacy are received

4. Responsibility Quality Assurance (QA) will take the overall responsibility for co-ordination of Recall. In the absence of QA, Plant Manager will assume the responsibility.

5. Attachments Product Recall Report

6. Procedure 6.1 Initiation of product recall

6.1.1 If there is a market complaints about the product's risk

6.1.2 If manufacturers, wholesalers, retailers and hospital pharmacists reports possible occurrence of health risk

6.1.3 If the sample failed in analysis tested by National Medicine Laboratories (NML) or by private testing laboratories

6.1.4 If the health publications shows the risk

6.2 Preliminary recall assessment (gathering and reviewing following document about the product):

6.2.1 Product information

6.2.2 Labels of the product

6.2.3 Distribution pattern

6.2.4 Product complaints

6.2.5 Product specifications

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6.2.6 Operations manuals, brochures, flyers, or any other product related literature that will aid in determining the violation and evaluation of the product problem

6.2.7 Formulation of the product

6.2.8 Analytical report and methods used to obtain the results of the product involved

6.2.9 Process validation protocols and reports

6.2.10 Analytical validation protocols and reports

6.3 Identification of a root cause of a potential product non-compliance issue

6.4 Decide whether to recall the product or not

6.4.1 If recall is not required, response to customer accordingly

6.5 If recall is required, distribution record shall be checked and following information to be sent to Export department for recall of product

6.5.1 Product(s) name

6.5.2 Batch number

6.5.3 Nature of defect

6.5.4 Date of Manufacturing

6.5.5 Date of Expiry

6.5.6 Exported to

6.5.7 Point of recall

6.5.8 Total quantity to be recall

6.5.9 Shipper carton no. or container no.

6.6 The QA shall ensure that all those, within the company, concerned with the storage, packing and destruction of products and materials are aware of the problem and action to be taken.

6.7 The QA shall convey following information to concern department

6.7.1 Name of product(s)

6.7.2 Batch number(s)

6.7.3 Nature of defect

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6.7.4 Action to be taken

6.8 All affected, or potentially affected, kits and any other stocks or materials shall be securely segregated, and effectively quarantined so as to be sure they cannot be dispatched.

6.9 The QA shall arrange for prompt preparation of a list of the recipients of the defective product

6.10 According to the urgency/extent of potential risk, direct mailing, telephone call, email or fax shall convey this information

6.11 If the defect is considered to be too serious to permit any delay, steps must be taken to inform all potential or possible recipients without necessarily waiting for the collection of full distribution data.

6.12 If defect is considered to represent a serious and immediate risk to user or consumers, then consideration must be given in consultation with marketing department to the use of the media to provide wider awareness of the problem.

6.13 When recall has been initiated, arrangements must be made by QA to receive the returned goods, and to ensure that they are securely segregated from other stock, and stored in specified area.

6.14 The progress of the recall shall be recorded and monitored by QA, so that the quantity of goods returned can be reconciled against the amount produced, distributed, and still held in stock.

6.15 Timeline of maximum 5 days from class I recall, up to a maximum of 10 days for class II recall and up to a maximum of 30 days for class III recall shall be permitted

6.16 Communicate/warn public/related professionals and institutions about the health risk of the recalled product.

6.16.1 In cases of class-I recall, public announcements shall be made to stop the usage of the drug immediately, using fastest mode of communication such as newspapers, television, radio, and the internet

6.17 When it is considered that the recall/freeze has been accomplished as completely as possible, a full report shall be prepared by the QA.

6.18 The detailed report shall contain

6.18.1 Reason for recall/freeze

6.18.2 Results of full investigation into cause(s) of the defective product

6.18.3 Action taken to recall etc.

6.18.4 Numerical details of the reconciliation exercise

SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL

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6.18.5 Action taken to prevent re-occurrence.

6.18.6 Copy of this report shall be forwarded to Managing Director.

6.19 Monitoring and follow up action must be done to ensure recall action is effective and remedial action taken to prevent a recurrence of the defect.

6.20 Documentation of findings

6.21 Closure of a Recall

7. Definitions 7.1 Class I: Defects are potentially life threatening or could cause a serious risk to health

7.2 Class II: Defects could cause illness or mistreatment, but are not Class I

7.3 Class III: Defects may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons

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PRODUCT RECALL REPORT REFERENCE NUMBER

Product Recall Class of Defect (Choose either class I, II or III)

I. II. III.

Product Name (Both Brand and Generic Name)

Marketing Authorization Number

Dosage Form

Strength

Batch Number

Expiry Date

Manufacturer Name and Telephone Number

Recall Number assigned

Information on distribution including exports

Details on Defect/ Reason for Recall

Results of Full Investigation into Causes of Defect

Actions Taken to Recall

Actions Taken to Prevent Re-occurence

Signed

Date

SOP # C107 REVISION # 00 EFFECTIVE DATE 06/15/14 SOP ON PRODUCT RECALL

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