SOP OF PRODUCT RECALL
PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different parties related to the recall of medicinal products, which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health. The procedure may be used also for transmission of other information such as caution in use or product withdrawals for safety reasons.
SCOPE: This procedure is applicable for medicinal products manufactured
RESPONSIBILITY: It is the responsibility of Head Quality Assurance to ensure the compliance with this procedure in consultation with Quality Assurance Head of contract giver.
ACCOUNTABILITY: Head QA shall be accountable for this SOP.
PROCEDURE:
Mock Recall: A mock recall is called a simulation of a recall inside a site or company. The intend is to verify the effectiveness of the internal steps in the recall procedure.
Product Recall: The product recall is basically the removal of one or more batches of product from the market.
Information regarding products that may be deemed unfit for their intended purpose, may be received from.
Any Customer
Any other person as applicable
Any regulatory Authority
The person receiving information regarding a defect product shall endeavor to obtain the following information from the informant
Name, address and telephone number of the complainee.
Name, batch number and expiry date of the defect product.
Details regarding the nature of the defects.
Obtain an estimate of the quantity of product within the distribution chain on the basis of product dispatched from the company and the known sales experience.
Sample of defected batch(es) of the product.
On receipt of information regarding a product defect, Head Marketing shall pass the information without delay, to Head QA.
On receipt of the information the Head QA shall determine whether the defect is
Critical – defects are potentially life threatening. (A situation where there is a reasonable probability that use of or exposure to, the Product may cause a serious consequence or death.)
Major – defects should cause illness or mistreatment but are not Critical (A situation where the use of exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.)
Minor – defects may not pose a significant hazard to health. (A situation where the use of exposure to the product is not likely to cause adverse health consequences.)
The Head QA
Shall contact the complainant directly to verify the nature of the product defect.
Shall request for additional information, as applicable, from the Marketing / business agent (incase of export).
The Head QA shall obtain total distribution record of batch(es) from the distribution/export department
Examine the retained sample for signs of defect.
With the assistance of the Marketing Department, identify customers having received product from the batch in question.
Place an immediate hold on further distribution of the batch(es) of the deemed defective product.
On receipt of information regarding a defect product, the Head QA shall immediately call a meeting of the recall committee and present as full details as are available relating to the defect product
A recall committee shall be set up, consisting of:
Chairman Managing Director (If Necessary).
Head Quality Assurance.
Head Quality Control and Formulation and Development.
Head Production.
Head Marketing
Businesses agent as communicators (incase of export).
Head Quality Assurance of contract giver
Other as considered appropriate.
A timetable shall be established for obtaining further necessary information regarding the defect product identifying the person(s) responsible for obtaining such information. A report of all findings shall be presented to the committee within a specified time. In any event, the committee shall be informed about findings on a daily basis.
The Head Quality Assurance shall act as chairman and co-ordinator of all recall activities.
The recall committee shall be based on the recall level, inform immediately to customer.
The recall committee shall inform to customer about decision to recall, by email/ telephone /telegram/electronic media (Television)/Newspaper publishing and / or personal visit.
All the recalls, notification, alert will be done by third party /contract giver as per their procedure.
Defected product must be recovered from the customer as expeditiously as possible.
QA Head will reconcile the received quantity against the details provided by third party after receiving product at site.
Quality Assurance shall maintain a “Product Recall Register” with details as described in the for all the products recalled at the site
The Quality Assurance Department assigns tracking number to recalled products as follows
Product Recall Reference No: PR-XY-001
Where
PR- stand for Product Recall
XY- stand for last two digits of respective year
001 stand for the continuous serial number of respective product recalled in the respective year.
All received quantity of recalled product will be stored in ‘Quarantine Area’ designated for the purpose and affix the status label “Recalled Product”.
Place all recovered product in a secured place with proper status label until the recall is completed and further decision.
A report on the progress of all the recall shall prepare initially on a daily basis (for first 2 weeks) then weekly thereafter, until such time as the recovery is complete, or no future recovery is likely or practical.
The reason for recall will be jointly investigated by Head QA and its team along with the representative of third party/contract giver (if applicable).
The findings of the investigation shall be submitted to management and to the Head QA of third party/contract giver for the further action.
Action as proposed by Head QA and third-party management (for third party’s products) shall be implemented.
Product Recall Report shall be prepared as per format of “Product Recall Report”.
Mock Recall: The effectiveness of activities related to recall must be periodically evaluated through mock recall and Frequency for mock recall shall be once in two years.
Recall Classification
Critical: defects are potentially life threatening. A situation where there is a reasonable probability that use of or exposure to, the Product may cause a serious consequence or death.
Major: defects should cause illness or mistreatment but are not Critical A situation where the use of exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.
Minor: defects may not pose a significant hazard to health. (A situation where the use of exposure to the product is not likely to cause adverse health consequences.
The Quality Assurance Department shall prepare Mock Recall Validation Protocol. The Quality Assurance Head shall select the batch for Mock Recall and take approval from Corporate Quality Assurance Head for the same. The depth of mock recall level shall be decided by corporate Quality Assurance Head.
After getting approval for Mock Recall, Quality Assurance Head shall initiate the mock recall activity. After initiation of mock recall, the information network should be able to locate the distribution channel and provide the intimation to freeze the stock within 24 hours, and the finished product shall be returned to central warehouse within 10 days. The time of mock recall is based on the geographical regions and climatic conditions.
The product recall system shall be validated by conducting the mock recall. The mock recall shall be evaluated and shall be recorded. On the basis of evaluation of Mock Recall, Head QA shall provide recommendations if required (viz. changes in existing product recall system for improvement).
Mock Recall for products manufactured on contract basis: Mock Recall shall initiated by contact giver and recall committee decide and arrange mock recall procedure through head QA of contact giver.
Recall Termination: On completion of the execution of the recall strategy the recall co-ordinator shall submit a written report. The recall is not considered closed until the Agency sends official notice that recall is terminated. This shows normal procedure (SOP) to be followed for day to day practice.
REFERENCE:
SOP FOR SOP
ANNEXURES:
- Product Recall Report
- Product Recall Register
- Recalled Product Label
- Standard Product Recall Letter
- Dummy Run Protocol