SOP on Product Recall System

SOP on Product Recall System

1.0 Purpose: This SOP defines the procedure for the recall of a failed drug product batch.

2.0 Scope: This SOP applies to all failed drug product batch(es). 

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: None.

5.0 Procedure: Recall means a firm’s removal or correction of a marketed product that the Drugs Control Authorities consider to be in violation of law. 

5.1 Recall Classification – Recall classification means the numerical designation assigned by Drugs Control Authorities to a particular product recall to indicate the relative degree of health hazards presented by the product being recalled.

Class I: Is a situation in which, there is reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II: Is a situation in which use of or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where probability of serious adverse health consequences is remote.

Class III: Is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Recall may be undertaken voluntarily by the company or at the direction of Drugs Control Authorities and the company should decide the time period within which recalls to be completed for that product.

5.2 Recall Strategy: A recall strategy addresses the following elements regarding the conduct of the recall – 

1.0 Depth of Recall: Depending upon the products degree of hazards and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to be extended as follows – 

1.01 Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or

1.02 Retail level, including any intermediate wholesale level; or

1.03 Wholesale level.

2.0 Public Warning: The purpose of a public warning is to alert the public that a product being recalled presents a serious health hazards. Whenever the public warning is needed, it will issue as – 

2.01 General public warning through the general news media, either local or national, as appropriate.

2.02 Public warning through specialized news media, e.g. professional or trade press, or to specific segments of the population such as physician, hospitals, etc.

3.0 Product Checks:  The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notifications about the recall and have taken appropriate action. The recall strategy  specifies the methods to be used for and the level of effectiveness checks that will be conducted as follows – 

3.01 Level A – 100% of the total number of consignees to be contacted.

3.02 Level B – Some % of the total number of consignees to be contacted, which is to be determined on a case-by-case basis, but is greater than 10% and less than 100% of the total number of consignees.

3.03 Level C: 10% of the total number of consignees to be contacted.

3.04 Level D: 2% of the total number of consignees to be contacted.

3.05 Level E: No effectiveness checks.