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AssistingCompaniestoComplyWithU.S.FDAElectronic
DeviceRegulations.
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
Scope:This Standard Operating Procedure is applicable to the product recall of the products manufactured at the formulation plant of
Responsibility:
QA Head : Initiation for product recall,Communication to concerned department,Initiation of investigation,Product Review (current &
Distribution Department: Provide distribution list,Facilitating recall from all distribution points,Ensuring stoppage of further sale &
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,
Based on the recommendations given in market complaint Investigation, QA Head shall decide for product recall.
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
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
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health
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.
rd th
3 and 4 characters represent the last two digits of year 2016.
The reasons and conditions of the product recall and its class shall be discussed by QA Head, Regulatory, Marketing. An action plan shall
If the product batches to be recalled are from the regulated markets, necessary communication will be sent by QA Head to the
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,
QA Head shall advise Distribution department and Marketing department to instruct the distributors and stockists to stop further
The communication can be sent by telephone, email, fax, and any other faster mode. Where required this may also be put on
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
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
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
All corrective actions and de ciencies shall be documented in the Recall Report.
Distribution
History
ReasonforRevision
Date Revision Number
00 New SOP
Annexure-I
1.1 Initiated By
1.4 Market:
Total Quantities:
Pack sizes:
1.6 Recall Details:
Distribution destinations:
Mode of communications:
Follow-up results:
QA
Review by Head-
2.0
QA(comments):
Head-QA
Return of Goods:
Recall process review done by (names & signatures) QA, Distribution, Marketing:
4.3 ..,
Closure Approved by QA
Name Signature Date
Head
Annexure-II
Bangalore Bhopal