1.0 PURPOSE:
2.0 SCOPE:
This SOP is applicable to conduct the mock recall of finished product manufactured at (Company name). The scope does not include confirmation of all the processes that may be necessary to reflect a recall is challenged.
3.0 DEFINITIONS:
Mock recall is conducted to assess whether the recall process can effectively identify and promptly manage a specific lot of potentially affected products, while also ensuring accurate reconciliation of the quantities produced, those in inventory, and those distributed.
4.0 RESPONSIBILITY:
5.0 PROCEDURE:
5.1 No contact shall be made with customers, contract clients or Regulatory agencies, unless specifically authorized by Head-QA.
5.2 Upon the direction of Head-QA or his designee “Mock recall shall be initiated to ensure that the established mechanisms that must be initiated during true recall are effective.
5.3 A senior person from QA department shall be nominated to have management responsibility for the administration of the mock recall.
5.4 Adequate staffing and proper prioritization shall be allocated to ensure the exercise is completed within a single workday.
5.5 For the purpose of this exercise, the Head-QA shall select a specific batch of distributed finished product that shall be considered for mock recall.
5.6 In order to evaluate the product recall program, periodic mock recall should be carried out at least once in two years for at least one batch of any product, dispatched for sale where maximum distributor are involved to test the effectiveness of arrangement of recall.
5.7 All information obtained during the mock recall shall be documented in simulation Protocol & Report of Mock Recall.
5.8 Any corrective action and deficiencies observed during mock recall shall be documented in the simulation recall protocol & report.
5.9 Following points shall be referred for process of the mock recall:
5.9.1 Selection of product batch:
5.9.1.1 Selection of Batch number shall be included based on the following criteria’s:
5.9.1.2 Product selected for mock recall shall be manufactured with sufficient number of Batches manufactured at the site.
5.9.1.3 Batch number selected shall be manufactured latest before 6 month.
5.9.1.4 Batches shall be manufactured prior to and after the Batch selected for Mock Recall.
5.10 Initiation of Mock Recall:
5.10.1 A Simulation Protocol for Mock Recall shall be prepared as per SOP for product recall. Mock recall shall be performed at schedule intervals of its frequency and a summary report shall be prepared after execution.
5.10.2 Acceptance criteria:
The acceptance criteria for mock recall as follows:
Raw material consumption traceability report-within 8 hrs
Sending circular by distribution department- Within 8 hrs
Response of circular from the stockiest and C&F- within 48 hrs
Reconciliation of batch from the date of initiation of recall- with in 72hrs.
5.10.3 Initiate the Mock Recall activities with start of date and time.
5.10.4 Mock Recall Team Committee consists of the concerned personnel of respective function department (PPIC/Warehouse/Production/QC/QA) and its Head QA.
5.10.5 Send circular to all the stockiest up to the retailer level to which the consignment of the batch is dispatched is to be retrieved.
5.10.6 Recall Coordinator shall instruct the PPIC department to contact with the Marketing Head and the third party through fast communication and collect information about routes of distribution of the consignment to various stockiest up to the retailer level and also get the current stock lying with the individual stockiest.
5.10.7 Meanwhile Recall Coordinator shall collect and review to ensure the correctness of all the related documents related to the Batch Number subjected for recall, but not limited:
Bach manufacturing & Packing Records
COA’s of all the Raw & Packing Materials.
COA’s of the Bulk and Finished Products.
Various Log Books of the Recalled Batch,
Dispatch details and Invoice.
Any Deviations/Change Control/Rework/Reprocess etc.
5.10.8 Check the Control Samples and record for their physical characteristics.
5.10.9 Photocopies of all the reviewed documents shall be enclosed with the and report.
5.11 The following additional information must be confirmed on each occasion:
5.11.1 The current telephone and fax number of the Regulatory Agencies are available.
5.11.2 Current telephone numbers are available for all C&F agents / distributors / customers identified in the mock recall.
5.11.3 The formal report of the mock recall must be produced by the administrator, and together with all records must be maintained for a minimum period of five years. The report should pinpoint any procedural weaknesses uncovered during the exercise and provide specific recommendations for addressing them.
5.11.4 It will be the responsibility of the Administrator to ensure that appropriate action is taken to implement those recommendations promptly to ensure that procedures are appropriate and up to date in the event of a true recall.
5.11.5 Mock Recall exercise shall be carried out once in two years.
6.0 ABBREVIATIONS:
SOP :Standard operating procedure.
QA :Quality assurance
COA :Certificate of Analysis
PPIC :Production Planning and Inventory Control
7.0 REFERENCE:
8.0 ENCLOSURES:
Also read: SOP for quality risk management
Also read: 6 Steps of FMEA (Failure Mode Effects Analysis)