SOP For Product Recall Management System QA-010

FOR RESTRICTED CIRCULATION ONLY
LOGO Company Name {Address}

Standard Operating Procedure
Title: SOP for Product Recall Management System
Department: Quality Assurance SOP: No.:
Issue No. Revision No. Effective Date Review Before Page No.
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Written By / Reviewed By and Authorized /

Approved By Signature
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1. Objective:
The objective of this procedure is to outline the steps to be taken in the unlikely event
of a product recall.
2. Scope:
This SOP is applicable to recall quality defective drugs when reported incidents of
safety and efficacy are received.
3. Responsibilities:
Document Control:
To prepare the SOP on approved format and initiate the process of recall, assigning a
number to the recall. Maintaining records. Preparation of investigation reports. To
prepare the comprehensive report of recall and share with drug recall committee.
Manager Quality Assurance:
To assess the criticality of complaint and advocate the criticality to drug recall
committee.
To write the official intimation for the break of sell, distribution and to initiate recall.
Responsible for follow-up action to check the effectiveness of the recall. Suggesting
corrective actions. Ensuring implementation of corrective action.
Head of Quality Operations:
Responsible to approve, authorize & audit the compliance of SOP and corresponding
with the regulatory bodies.
4. Acronyms:
Product recall: A process for withdrawing or removing a pharmaceutical product
from the pharmaceutical distribution chain because of defects in the product,
complaints of serious adverse reactions to the product and/or concerns that the
product is or may be counterfeit. The recall might be initiated by the manufacturer,
importer, wholesaler, distributor or a responsible agency.
Classification of Product Recall:
Class I Recall: This is an emergency situation involving the Removal of the
particular product or batch (s) from marketing and distribution channels those Product
or Batch (s) that, because of a deficiency, pose an immediate or long-term serious
threat to health or life. This is a health hazard situation where there is a reasonable
probability that the use of the product will cause serious, adverse health
consequences or death.
 Reported or confirmed illness
 Product tampering which could result in injury
 Adverse finding by a regulatory agency of a hazard
 Presence of an undeclared allergen in a product
In a Class I recall, top priority must be given to the complete and immediate removal
of the recalled products from all levels in the distribution chain all the way down to the
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consumer level. When implementing a Class I recall it is imperative that all personnel
involved understand the urgency of the situation and that all actions reflect this
urgency.
 A complaint form must be completed; identifying the product,
code date, and the issue requiring that a recall be implemented.
 The complaint form must highlight that a health risk is present.
 Any product remaining under business control must be placed on hold.
 All suppliers must be notified so they can locate any product in
transit and prepare for replacement of product. The complaint
form shall be faxed to the initial contact of the supplier.
Class II Recall: This is a priority situation in which a product deficiency may cause
temporary or medically reversible adverse health consequences and where the
probability of serious adverse health consequences is remote. The probability of
serious adverse health consequences is slight or nonexistent.
In Class II recall, products must be removed from all levels in the distribution chain.
When implementing a Class II recall, effort shall be made to replace the customer’s
product as soon as possible.
 A complaint form must be completed; identifying the product, code
date, and the issue requiring that a recovery be implemented.
Class III Recall: This is a routine situation in which adverse health consequences
of a product deficiency are highly improbable or non-existent. Products are recalled
because of adulteration or misbranding not involving a health hazard. The use of the
product is not likely to cause adverse health consequences. When implementing a
Class III recall, effort shall be made to replace the customer’s product as soon as
possible.
 A complaint form must be completed; identifying the product, code
date, and the issue requiring that a recovery be implemented.
Correction: The repair, adjustment, re-labeling, or inspection of a product without
actually removing it to another location.
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Retrieval: The removal of product at varying levels of the distribution system, store
sales, or consumers’ homes depending on the seriousness of the problem. There
are (3) levels of retrieval: Recall, Withdrawal, and Stock Recovery.
Stock Recovery: Removal or correction of an undistributed product that is still under
the direct control and ownership of producing and/or distributing company. No portion
of the lot has been released for sale or use.
Retention: Holding product from the market or from further processing or shipment
when there is evidence of a quality or labeling deviation in the formula for the target
species.
Recall Coordinator: The Recall Coordinator is the designated individual and is
charged with executing the recall strategy, communicating results within the company
and interfacing with regulatory agencies.
Recall Strategy: The planned course of action to be taken in conducting a specific
recall, which includes the depth of recall, the need for public announcements and the
extent of effectiveness checks.
Consignee: Anyone (customer, wholesaler or broker) who has received, purchased,
or used the subject product.
Distributor: A person or partnership who under their own name or a trade which is
control by them.
Effectiveness: Check includes a survey of those affected by the recall to verify they
have received the recall information and may include the verification of the action
taken
Withdrawal: The removal of a product where a health or safety hazard does not exist
but where a major quality defect or other major concern exists. May involve a minor
regulatory violation for which product seizure would not occur but may have other
legal consequences.
Types of Recalls:
1. Statutory Recall (Recall requested by Drug Regulatory Authority)

2. Voluntary Recall (Recall initiated by Manufacturer)
1. Statutory Recall:
Statutory Recall can be triggered in response to the direction or mandate by Drug
Regulatory Authority in one or more of the following situations:
 Substandard drugs/batch
 Banned drugs
 Out of specification
 Labeling and / or promotional materials, that are considered to be in violation
of Drug act 1976.
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2. Voluntary Recall:
Voluntary Recall can be triggered by any incident that affects the quality, safety
and efficacy of the batch/product in question such as:
 Batch/Product found defective during investigation of market complaint.
 Failure that might have adverse quality impact on released batch (e.g.
possibility of contamination, mix-up, and degradation) is observed during
investigation.
 Batch/Product not complying with the specification during the post marketing
stability studies.
 Post marketing surveillance/pharmacovigilance reports indicating serious
safety risk associated with the product.
Level of Recall:
Level (or depth) of recall of a product/batch shall be determined based on recall
classification and level to which distribution has taken place.
There are four levels of recall:
 Hospital level Includes: clinics, nursing homes and other institutions; clinical
investigators, and the institutions in which clinical investigations are performed;
hospital pharmacists, blood banks, pathology laboratories, operating facilities,
fractionators, human tissue banks and personnel in other hospital departments.
 Wholesale level. Includes: wholesalers, Include Stockiest as well, importers
State purchasing authorities etc.
 Retail level Includes: pharmacies, hospital pharmacies, dispensing physicians,
retail pharmacists; medical, dental and other health care practitioners.
 Consumer/user level Includes: patients and other consumers.
5. Procedure:
5.1. Any batch of a product not meeting the defined quality standards has to be recalled
from the market.
5.2. As soon as the product/batches to be recalled is/are identified, Manager Quality
Assurance shall review the information related to the defective product/batch
received and decide about recall in consultation with Drug Recall Committee in
meeting.
5.3. Senior Executive QA shall enter the details in the “Logbook for Product Recall”,
and assign a unique recall reference number representing the serial number for a
particular year in which the recall has been initiated.
5.4. After the decision taken for the recall of the product/ batches, the communication
shall be sent stating the severity of the defect, using the fastest mode of
communication which may include email, telephone, fax etc. to stop further
distribution of the batches in the stock.
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5.5. Manufacturer/Authorized Importer should inform Department of Drug

Administration/Ministry of Health where the product batch(s) in question was
distributed, immediately after the decision of recall has been taken.
5.6. Head of Quality operations of the manufacturing site shall inform the Distributor
/wholesalers/ Authorized Importer by fastest mode of communication which may
include email, telephone, fax, SMS etc. to stop further distribution of the batch(s) in
the stock and call back the stock available with the distributors, retailers etc.
depending on the seriousness of the defect.
5.7. Recall notice to distributors/wholesalers/Retailers shall be filled and sent to
respective distributor/Wholesaler.
5.8. Upon receipt of intimation, distributer will stopped the further sells and distribution
activates of the subject batch and/or product and check the distribution record to
identify the customers (wholesaler/retailer), where the subjected product/batches
have been distributed and forward the copies of the Recall Notice to them for further
necessary action.
5.9. The distributor shall block the available stock and shall ensure the blockage of stock
for further sale by reviewing the record.
5.10. The distributor shall send the “Summary Report of Recall” along with stock (if
any). All the returned stock shall be further forwarded to the warehouse.
5.11. Manager Supply Chain and Commercial Services shall send a periodical report to
Head of Quality Operations of manufacturing site, for the stock available with them
and the returns received from wholesalers.
5.12. Head of Quality Operations of the manufacturing site shall monitor the recall process
of product/batch to determine whether the recall is progressive satisfactorily.
5.13. The stocks of recalled goods shall be placed under “Quarantine” and stored
separately under lock and key in a secure area until further decision.
5.14. Manager QA shall reconcile the stock of the recalled product/batch against the total
quantity of the distributed stock and prepare a summary report of reconciliation. The
copy shall be forwarded to Head of Quality Operations for review and necessary
action.
5.15. The progress of the recall shall be recorded and monitored by QA, so that the
quantity of returned can be reconciled against the amount produced, distributed, and
still held in stock.
5.16. Time line for Class I recall would be as soon as possible or preferably 24 hours.
5.17. Manager QA shall perform the physical inspection and collect samples of recalled
Product / batch (s) for investigation to establish the root cause of the product quality
defect.
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5.18. The investigation of the recalled batch (s) shall be conducted to identify the root
cause of the failure and initiate Corrective and Preventive action.
5.19. Impact assessment shall be conducted on other batches of the concerned product
and further extended to batch (s) of other product/s, wherever applicable.
5.20. The decision to recall, if necessary, any of the impacted batches shall be made after
product quality assessment.
5.21. After accomplishment of the investigation and root cause, a final report shall be
prepared by QA and shared with Drug Recall Committee.
5.22. Based on conclusion of the final report, Drug Recall Committee shall decide to
appropriate dispose of the batches of the recalled Product / batch(s) as per the
regulations.
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Process Flow of Voluntary Product Recall:

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6. References:
 WHO Chapter I Medicinal Product Recall SOP

 Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use Part 1 Chapter 8: Complaints,
Quality Defects and Product Recalls.

SOP For Product Recall Management System QA-010

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LOGO Company Name {Address}

Written By / Reviewed By and Authorized /

1. Statutory Recall (Recall requested by Drug Regulatory Authority)

5.5. Manufacturer/Authorized Importer should inform Department of Drug

Process Flow of Voluntary Product Recall:

 WHO Chapter I Medicinal Product Recall SOP

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