U.S. FDA Requirements
SOP On Product Recall Posted Posted By: Pharmaceuti Pharmaceutical cal Guidanac Guidanace e on: April April 04, 04, 2016 2016 In: QA & QC, Quality Quality Assurance, Assurance, SOP 3 Comments Comments
Objective :To : To lay down procedure for prompt and eective recall of nished products known or suspected to be defective, from domestic and export market.
Scope:This 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 Assurance :Decision for recall,Reviewing status of recall QA Head : Initiation : Initiation for product recall,Communication to concerned department,Initiation of investigation,Product Review (current & other manufacturedbatches),Ensuring manufacturedbatches),Ensuring batch recalled is quarantined Distribution Department: Department: Provide distribution list,Facilitating recall from all distribution points,Ensuring stoppage of further sale & distribution of of suspected batches. Manager stores stores : Storage : Storage of recalled goods,Destruction of recalled goods. goods.
Accountability: QA Head shall be accountable for implementation of this SOP.
Abbreviations and De舂nitions
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, ecacy 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 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 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 classied as:
Class I recall: a recall: a situation in which there i s a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: 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
3
th
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 Aairs. 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 aected 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 identied in the recall procedures, they should be corrected. All corrective actions and deciencies 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
Date
Revision Number
–
00
Reason for Revision
New SOP
Annexure-I
Product Recall Form
Date:
1.0 Recall Initiation
Product Recall No.:
1.1
Initiated By
1.2
Product Name:
1.3
Batch Size:
1.4
Market:
1.5
Reason for Recall
(to be assigned by QA)
Batch No.:
Batch number wise Total Quantities:
Pack sizes: 1.6
Recall Details: Distribution record verication:
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):
Category:
__________
Initiated by
Name
Signature
Date
Signature
Date
QA
Review by Head2.0 QA (comments):
Review by
Name
Head-QA
3.0
QA Review / Approval
4.0
Implementation of Product Recall
Approved
Rejected
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 Fullled:
5.2.2
If No, Justication:
5.2.3
Data Generation Completed:
5.2.4
If No, Justication:
5.2.5
Can the Product Recall Be closed? :
5.2.6
Remarks (if any):
Yes /
No
Yes /
No
Yes /
No
Closure Approved by QA Name Head
Annexure-II
Logbook of Product Recall
Signature
Date
Batch
Disposal
Product
Closure Strength
Sr.
Recall
Product
Batch
No
Report
Name
No.
Reason Batch
Mfg
Exp
Size
date
Date
& Pack
for
Size
Distribution Details
Qty
Principles of Due Diligence - Free PDF Download
B hop al
Qty
Recall
Recalled
Reconciliation
of Recall Plant
B ang al or e
of of
Initiation
Recall
No.
Date of
Recalled Material
on done on
Remarks
