Product Recall

Product Recall

OBJECTIVE:

To lay down the Procedure for handling Product Recall.

PROCEDURE:

• Recall: Recall means a firm’s removal of products from the market that considers being adverse reaction or in the case of patient safety, a violation of the law.
• Withdrawal: Withdrawal means a firm’s withdrawal, removal, or correction of a distributed product from the warehouse which involves a minor violation or pack size correction, patient safety information, or any legal notification that needs to be added to the product literature.

Recall classification:

Recall shall be based on the severity of defect or directive violations. On this basis defects & violations, the recall shall be categorized as under –

CLASS – I (Critical): recall shall be initiated in which patient safety or life-threatening.

CLASS – II (Major): recall shall be initiated in case of adverse drug reaction but life-threatening consequences will not be there.

CLASS – III (Minor): recall shall be initiated in case of the product does not have a significant hazard to patient health and is life-threatening but the product does not meet on stability study predetermine specification or any change in behavior.

• The procedure for recall applies to the products already distributed in the markets for which reports of Quality complaints have been received.
• Quality complaint could either be due to the efficacy of the drug or adverse drug reaction, which could create a life-threatening situation.
• Products with complaints likely to give rise to a serious adverse reaction or life-threatening situation to the consumer e.g. decomposition leading to toxic substances in the product, very low assay leading to no drug effect or any other life threatening situation or discoloration of product or product changing in physical properties should be RECALLED.
• Complaint which leads to adverse drug reaction or life threatening situation should be considered as critical & recall from consumers, retailers, distributors, hospital supplies should be initiated on War footing. Recall action should be initiated immediately.

Recall shall be done as per their classification

• Class – I: Recall shall be started immediately and it shall be completed within 12-24 hours from the consumer’s level or user level including any intermediate wholesale or retail level.
• Class – II: Within 07 hours from the stockiest level.
• Class – III: Within 30 working days from the stockiest level.

Product recall must be initiated for any one of the following reason

• Critical customer complaints due to any adverse drug reaction
• GMP failure issue
• Failure in Ongoing Stability samples
• Formulation problem/mix-up/contamination/cross-contamination.
• Packing errors, labeling errors.
• Regulatory reasons
• Forced Recall (Instruction from Regulatory Authorities) this is upon discovery of deficiency or violation of regulatory/GMP norms.
• The voluntary recall by the manufacturer is recalling from the distribution network of the entire quantity. This shall be due to:
• In-House adverse findings during ongoing stability study of a product.
• Critical findings related to product quality, safety and efficacy.
• Formulation problem/mix-up/contamination/cross-contamination.
• Packing errors, labeling errors.
• Evaluation of procedure effectiveness.
• Other reasons deemed fit for recall.

Numbering of Recall

The recall number shall consist of 10 alphanumeric characters (PR/XX/YYY).

• The First 2 characters are alphabets ‘PR’ indicates that the document is Product Recall.
• 3^th character is ‘/’.
• 4^th and 5^th characters are also numerical which indicate year.
• 6^th character is ‘/’.
• Last 3 characters are numerical which indicate sequential number .

On receipt of the Quality complaint from the market to QA, shall initiate the investigation as per Attachment I.

QA shall advise Marketing Department to instruct the distributor to stop further distribution.

QA shall ensure a complete investigation of the complaint or any drug adverse reaction.

QA will prepare the investigation report.

On the basis of the investigation report, the determination of recalls will be assessed by the recall committee. A recall decision shall be recommended by the QA along with the recall committee.

Once the recall is decided, QA Head shall obtain the approval for product recall from the Managing Director.

Once the recall is approved by the Managing Director, the Head of QA asks the Warehouse In-Charge to provide the Status of the Batch under Recall / Mock Recall to know the product distribution status.

After that QA Head informs the Head of Marketing in writing about the recall and also provides the filled form of Status of Batch under Recall / Mock Recall.

The Head of Marketing then initiates the recalls from all distribution points by intimating the concerned personnel by sending the Recall / Mock Recall Notice. The Marketing Head asks all distributors and retailers to provide a minimum of the following information:

1 – Name, address, and telephone number of the distributors and retailers

2 – Received quantity of the product

3 – Existing stock details of the product

4 – Sell-Out stock details of the product

If the complaint is critical, then inform the patients by means of newspapers, TV, etc. so that they do not use the product.

Marketing should share with QA the records of recalled products received from each location with all supporting documents.

Once the recalled goods arrived at the site, Warehouse personnel shall reconcile the goods & quantity shall be verified by QA.

Recall goods shall be stored under lock & key at a designated place.

After complete reconciliation, QA shall ensure the product dispose of as per the destruction procedure. Government authorities should be informed about the same.

In case of destruction need to be done at the country site as per their rule and regulation, the reconciliation record shall be shared with plant QA by the country/ marketing head.

Product recall must be closed off within one month period.

On completion of the recall procedure, a Product Recall / Mock Recall Report (Attachment V) shall be prepared.

All product recalls shall be documented in the product recall log.

Product recall may call for a decision to continue the manufacturing or suspension of the product depending upon the severity of the complaint.

Mock Recall

Definition: A mock recall is an internal exercise to test a company’s ability to trace and recall products using their documented traceability and recall plan. When performing a mock recall one need to create a scenario of a problem with a delivered product. The mock recall should have as close to 100% reconciliation of all implicated products as possible.

In order to evaluate the product recall program, periodic mock recalls should be carried out at least once every 3 years. All information obtained during the mock recall shall be documented in the Product Recall Log. The mock recall file should include the name, address, and telephone number of distributors and retailers, production records, the inventory, and distribution of batches 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.

The procedure of mock recall

Either QA or Product Recall Committee plans to conduct the mock recall of existing products once every 3 years and a mock recall decision shall be recommended by the QA along with the recall committee.

Once the mock recall is decided, QA Head shall obtain the approval of the mock recall from the Managing   Director.

Once the mock recall is approved by the Managing Director, the Head of QA asks the Warehouse In-Charge to provide the Status of the Batch under Recall / Mock Recall to know the product distribution status.

After that QA Head informs the Head of Marketing in writing about the mock recall as per Attachment II and also provides the filled form of Status of Batch under Recall / Mock Recall.

The Head of Marketing then initiates the mock recall from all distribution points by intimating the concerned personnel by sending the Recall / Mock Recall Notice (Attachment III). The Marketing Head asks all distributors and retailers to provide a minimum of the following information:

1 – Name, address, and telephone number of the distributors and retailers

2 – Received quantity of the product

3 – Existing stock details of the product

4 – Sell-Out stock details of the product

The marketing Head should share with QA the records of products under mock recall received from each location with all supporting documents.

After receiving the information on the product under mock recall, QA forwards this information to the Warehouse, and Warehouse personnel shall reconcile the product and the reconciliation details to be submitted to QA.

Finally, QA prepares a Product Recall / Mock Recall Report (Attachment V) and verifies the effectiveness of the mock recall procedure. The mock recall should achieve as close to 100% reconciliation of the mock recall product as possible.

Mock recall activity shall be recorded in the Product Recall Log.

Note: All attachments of this SOP shall be used for actual recall and mock recall. Before filling any form it is required to tick mark what it is – actual recall or mock recall.