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SOPOnProductRecall
Posted By: Pharmaceutical Guidanace on: April 04, 2016 In: QA & QC, Quality Assurance, SOP 3 Comments

Objective :To lay down procedure for prompt and e ective recall of nished products known or suspected to be defective, from

domestic and export market.

Scope:This Standard Operating Procedure is applicable to the product recall of the products manufactured at the formulation plant of

Pharmaceutical (Company Name ).

Responsibility:

Quality Assurance :Decision for recall,Reviewing status of recall

QA Head : Initiation for product recall,Communication to concerned department,Initiation of investigation,Product Review (current &

other manufacturedbatches),Ensuring batch recalled is quarantined

Distribution Department: Provide distribution list,Facilitating recall from all distribution points,Ensuring stoppage of further sale &

distribution ofsuspected batches.

Manager stores : Storage of recalled goods,Destruction of recalled goods.

Accountability:QA Head shall be accountable for implementation of this SOP.

Abbreviations and Denitions

SOP:Standard Operating Procedure

QA: Quality Assurance

Procedure

Any written communication received from complainant (Distributor/ retailer / stockiest/ Field sta / customer / doctor) regarding

the defects in product quality (purity, e cacy and any adverse drug reaction) including its physical characteristics, packaging,

labeling etc. shall be investigated as per SOP on handling of market complaints.

Based on the recommendations given in market complaint Investigation, QA Head shall decide for product recall.

The product recall could be Voluntary or Forced.

Voluntary Recall is done for Products by the manufacturer when any adverse reaction is brought to the notice directly to the manufacturer or

when the manufacturer has noticed problems in the product quality or stability.

Forced Recall is done on instructions by the Regulatory Authority when any adverse reaction or untoward incident is reported by the general

public, hospitals, physicians or any laboratories.

Recall can be classi ed as:

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse

health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health

consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

QA shall ll up Product Recall Form as per Annexure-I. Each product recall form shall be assigned a unique alphanumeric number of 7

characters by QA department.

For example, PR16001

Where, rst two characters PR stands for Product Recall.

rd th
3 and 4 characters represent the last two digits of year 2016.

The last three characters denote sequential serial number.

The form shall be forwarded to QA Head for approval.

The reasons and conditions of the product recall and its class shall be discussed by QA Head, Regulatory, Marketing. An action plan shall

be prepared by this group.

If the product batches to be recalled are from the regulated markets, necessary communication will be sent by QA Head to the

respective Regulatory Authority, after consulting Regulatory A airs.

The Product Recall shall be initiated promptly no sooner the decision is taken by QA Head. Necessary communication shall be sent to all

concerned within the shortest time period, but not later than 72 hours in case of Class I and Class II.

The Distribution record shall be checked by QA Head in consultation with Distribution Department to identify the destinations,

the quantities, batch number-wise.

QA Head shall advise Distribution department and Marketing department to instruct the distributors and stockists to stop further

dissemination and sale of the product batches.

The communication can be sent by telephone, email, fax, and any other faster mode. Where required this may also be put on

news media, but only in case of Class I recall.

A follow-up on the communication and response to it shall be monitored by QA, Distribution and Marketing department.

Necessary arrangements shall be administered by the Supply chain to receive the recalled product batches quantities. The returned

stock shall be reconciled to the closest quantity of actual distribution.

This reconciliation shall consider all unit or pack of batches under recall even from hospital and pharmacy stores. The batch

documentation and reconciliation shall be thoroughly scrutinized by competent personnel from QA, Distribution and Marketing

departments.

In the likelihood of possibility of destruction of stocks in the country of market, the QA Head shall delegate responsibility to the supply

chain to do so with the permission of the local Regulatory authority.

The returned/ recalled stocks shall be destroyed as per the destruction procedure.

All records and communications related to Product Recall shall be properly maintained by the respective departments, such as

Distribution department, Marketing department and QA as per Annexure- II. These records shall be reviewed by QA for adequacy and

accuracy.

The local Drug Control Authority shall also be informed of such recalls by QA.

Mock Recall-In order to evaluate the product recall program, periodic mock recalls should be carried out at least once a year. All

information obtained during the Mock recall shall be documented on the Recall Log. The mock recall le should include the name,

address and telephone number of clients for the lot tested, production records, the inventory, and distribution of lot distributed.

Mock recalls are used to determine whether the recall procedure is capable of identifying and quickly controlling a given lot of

potentially a ected product and reconciling the quantities produced, quantities in inventory, and quantities distributed.

A mock recall will identify potential problems and allow personnel to become familiar with recall procedures. If problems are identi ed

in the recall procedures, they should be corrected.

All corrective actions and de ciencies shall be documented in the Recall Report.

Forms and Records (Annexures)

Product Recall Form Annexure-I

 Log Book of Product Recall Annexure-II

Distribution

Master copy Quality Assurance

Controlled copies Quality Assurance, Production, Stores, and Quality Control.

History

ReasonforRevision
Date Revision Number

00 New SOP

Annexure-I

Product Recall Form Date: __________

1.0 Recall Initiation

Product Recall No.: (to be assigned by QA)

1.1 Initiated By

1.2 Product Name: Batch No.: Category:

1.3 Batch Size:

1.4 Market:

1.5 Reason for Recall

Batch number wise

Total Quantities:

Pack sizes:
1.6 Recall Details:

Distribution record veri cation:

Distribution destinations:

Mode of communications:

Information to RA and inputs:

Information to Regulatory authority:

1.7 Proposed Recall Plan:

Returned Goods Receiving point:

Follow-up results:

Attachments / Supporting Data

1.8 (if any):

 Initiated by Name Signature Date

QA

Review by Head-
2.0
QA(comments):

Review by Name Signature Date

Head-QA

3.0 QA Review / Approval Approved Rejected

4.0 Implementation of Product Recall

Dates of Recall communications:

Stoppage of distribution & sale:

4.1

Return of Goods:

4.2 Quantities returned and Reconciliation:

Recall process review done by (names & signatures) QA, Distribution, Marketing:
4.3 ..,

Review by Name Signature Date

Head-Distribution

5.0 QA Review of Implementation & Closure

5.1 Summary Report of Recall:

5.2 QA Comments on Reconciliation:

5.2.1 All Recommendations Ful lled: Yes / No

5.2.2 If No, Justi cation:

5.2.3 Data Generation Completed: Yes / No

5.2.4 If No, Justi cation:

5.2.5 Can the Product Recall Be closed? : Yes / No

5.2.6 Remarks (if any):

Closure Approved by QA
Name Signature Date
Head

Annexure-II

Logbook of Product Recall

 Batch Disposal
Product Closure
Strength Reason Distribution Date of of
Sr. Recall Product Batch Batch Mfg Exp of Qty
& Pack for Details Initiation Reconciliation Recalled Remarks
No Report Name No. Size date Date Recall Recalled
Size Recall of Recall Material
No. on
Plant Qty done on

Principles of Due Diligence - Free PDF Download

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