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 a 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 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: This is a situation in which the 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 period within which recalls are 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 product 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 the 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 hazard. Whenever a public warning is needed, it will be issued 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 physicians, 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.
FAQs
1. What is the difference between a product recall and a product withdrawal?
A product recall involves the removal of a product from the market due to safety concerns or defects that could potentially harm consumers. It is typically initiated when a product poses a significant risk to health or safety. On the other hand, a product withdrawal is a voluntary action taken by a manufacturer, distributor, or retailer to remove a product from the market for reasons other than safety, such as quality issues or labeling errors. While both involve removing products from the market, recalls are usually more serious and involve a greater level of risk to consumers.
2. How often should companies conduct risk assessments for their products?
Companies should conduct risk assessments for their products regularly and as part of their ongoing quality assurance processes. The frequency of risk assessments may vary depending on factors such as the nature of the product, changes in manufacturing processes, regulatory requirements, and emerging safety concerns. Generally, risk assessments should be conducted whenever there are significant changes to products or processes that could impact their safety or quality.
3. What role do regulatory agencies play in the product recall process?
Regulatory agencies play a critical role in overseeing and regulating product recalls to ensure the safety of consumers. Depending on the jurisdiction, these agencies may have the authority to mandate recalls, set standards for product safety, and enforce regulations governing product recalls. They may also provide guidance and support to companies throughout the recall process, including monitoring the effectiveness of recall efforts and taking enforcement actions against non-compliant parties.
4. Can a product recall be voluntary or mandatory?
Yes, a product recall can be either voluntary or mandatory. A voluntary recall is initiated by the manufacturer, distributor, or retailer without regulatory intervention, typically in response to safety concerns or defects discovered in the product. On the other hand, a mandatory recall is ordered by a regulatory agency when a product is found to pose a significant risk to health or safety and the responsible party fails to take appropriate action voluntarily. Mandatory recalls are legally enforceable and may involve penalties for non-compliance.
5. How can companies minimize the financial impact of a product recall?
Companies can minimize the financial impact of a product recall by implementing effective risk management strategies, investing in quality control measures, and having comprehensive product recall plans in place. This includes conducting regular risk assessments, implementing robust quality assurance processes, maintaining accurate records of product distribution, and establishing clear communication channels with stakeholders. Additionally, companies can purchase product liability insurance to help cover the costs associated with recalls, including legal expenses, product replacement, and compensation for affected consumers.
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