SOP On Product Recall
To lay down procedures for prompt and effective recall of finished products known or suspected to be defective, from the domestic and export market.
This Standard Operating Procedure is applicable to the product recall of the products manufactured at the formulation plant of Pharmaceutical (Company Name ).
- Quality Assurance: Decision for recall, Reviewing the status of the recall
- QA Head: Initiation for product recall, Communication to the concerned department, Initiation of investigation, Product Review (current & other manufactured batches),Ensuring batch recalled is quarantined
- Distribution Department: Provide distribution list, Facilitate recall from all distribution points, and Ensure stoppage of further sale & distribution of suspected batches.
- Manager stores: Storage of recalled goods, Destruction of recalled goods.
- Accountability: QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- SOP: Standard Operating Procedure
- QA: Quality Assurance
Any written communication received from the complainant (Distributor/ retailer / stockiest/ Field staff/customer/doctor) regarding the defects in product quality (purity, efficacy, and any adverse drug reaction) including its physical characteristics, packaging, labeling, etc. shall be investigated as per “SOP on the handling of market complaints”.
Based on the recommendations given in the market complaint Investigation, QA Head shall decide on 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 of 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 classified 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 the 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 recalls a situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences.
QA shall fill up the “Product Recall Form” as per Annexure-I. Each product recall form shall be assigned a unique alphanumeric number of 7 characters by the QA department.
For example, PR23001
- Where the first two characters PR stands for “Product Recall”.
- 3rd and 4th characters represent the last two digits of the year 2023.
- The last three characters denote sequential serial numbers.
The form shall be forwarded to QA Head for approval.
The reasons and conditions for the product recall and its class shall be discussed by QA Head, Regulatory, and 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 Affairs.
The Product Recall shall be initiated promptly no sooner after 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, quantities, and batch number-wise.
QA Head shall advise the Distribution department and Marketing department to instruct the distributors and stockists to stop further dissemination and sale of the product batches.
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 departments.
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 units or packs 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 the possibility of destruction of stocks in the country of the 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 the 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 file should include the name, address, and telephone number of clients for the lot tested, production records, inventory, and distribution of the lot distributed.
Mock recalls are used to determine whether the recall procedure is capable of identifying and quickly controlling a given lot of potentially affected products 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 identified in the recall procedures, they should be corrected.
All corrective actions and deficiencies shall be documented in the Recall Report.
Forms and Records (Annexures)
- Product Recall Form – Annexure-I
- Log Book of Product Recall – Annexure-II
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Stores, and Quality Control.
Product Recall Form
1.0 Recall Initiation
Product Recall No.: (to be assigned by QA)
Product Name: Batch No.:_________________________Category:
Reason for Recall
- Batch number wise
- Total Quantities:
- Pack sizes:
- Distribution record verification:
- Distribution destinations:
Proposed Recall Plan:
- Mode of communications:
- Information to RA and inputs:
- Information to Regulatory authority:
- Returned Goods Receiving point:
- Follow-up results:
Attachments / Supporting Data (if any):
Initiated by QA
Review by Head-QA (comments):
Review by Head-QA
QA Review / Approval
Implementation of Product Recall
Dates of Recall communications:
Stoppage of distribution & sale:
Return of Goods:
Quantities returned and Reconciliation:
Recall process review done by (names & signatures) QA, Distribution, Marketing:…………………………
Review by Head-Distribution
QA Review of Implementation & Closure
Summary Report of Recall:
QA Comments on Reconciliation:
All Recommendations Fulfilled: Yes / No
If No, Justification:
Data Generation Completed: Yes / No
If No, Justification:
Can the Product Recall Be closed? : Yes / No
Closure Approved by QA Head
Logbook of Product Recall
- Sr. No
- Product Recall Report No.
- Product Name
- Batch No.
- Strength & Pack Size
- Batch Size
- Mfg date
- Exp Date
- Reason for Recall
- Batch Distribution Details
- Date of Initiation of Recall
- Closure of Recall on
- Qty Recalled
- Disposal of Recalled Material done on