SOP Title: Product Recall Procedure
- Objective:
To lay down procedure for recall of product which is found not to comply with the specification because of a defect in the products quality or because of a serious unexpected adverse drug reaction and withdrawn from the market immediately.
- Scope:
The procedure sets out the chain of communications and responsibility for product recalls of all complaints related to the product from the market, practical recall process and how a recall is to be monitored and documented.
- Responsibility:
| Contract Giver | : | Shall be responsible for approval of the decision to be taken on the complaint received and recall of the product from market. |
| Contract Acceptor | : | Shall be responsible for recalling of the product from the market (if instructed by the Contract Giver). |
| Recall Committee | : | Recall Committee consist of Plant Head, Head of QA, Logistics Manager and Director. |
- Accountability:
Head Quality Assurance Department/Plant Head
- Procedure:
5.1 Definitions:
Recall: The withdrawal from the market if a product is known or suspected to be defective.
Note:
1. The recall procedure is expected to be completed within 30 days in case of domestic market.
- The recall of product for the specific market shall be completed according to the regulatory norms of the respective country.
- The recall may apply to a particular batch of the product or extend to a general prohibition against any use of the product in consequence of new information including a health risk to its consumers.
- The recall shall only be made by Contract Acceptor when advised by Contract Giver.
5.2. Procedure:
| 5.2.1 | The Contract Giver shall advise and intimate for any product recall by email, fax or phone to the Contract Acceptor. The Head of QA shall pass it to the Recall Committee. Details provided by phone must be followed-up by written confirmation. | |
| 5.2.2 | Case Classification: Contract Giver shall recommend recall of the product under the following circumstances:
Category-I : A situation in which there is a strong likelihood that the use of, or exposure to a product will cause serious adverse health consequences or death. Category-II: A situation in which use of, or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Category-III: Defect in quality of the product with respect to physicochemical characteristics, purity, efficacy. Category-IV: No threat to patients or serious defect likely to impair product efficacy. Category-V: Voluntary Recall. |
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| 5.2.3 | Recall shall be initiated, but not limited to, the following circumstances:
—Formulation problems, product mix-ups and other contaminants. —Label mix-ups and errors. —Physical and visual deterioration like significant discoloration, sedimentation, crystallization etc. —Drop in assay of active ingredients below the statutory limits. —Results of ongoing stability studies show significant changes in physiological characteristics, purity, and microbial quality as prescribed in the specification. —Notification from API supplier of a defective material or batch of material. |
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| 5.2.4 | The Recall Committee will conduct meeting to decide the following next steps:
—Recall coordinator. —Recall action time limit. —Response to Contract Giver based on recall category. (Category I- within 24 hours, Category II-within 3 days, Category III-within 5 days, Category IV-within 7 days, Category V-within 15 days). |
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| 5.2.5 | If the recall falls under category I, manufacturer shall take an immediate action for recall and simultaneously inform the Contract Giver and DMRC (Defective Medicines Report Centre). | |
| 5.2.6 | If the recall is due to the defective API or batch of API, it shall immediately inform the same to the Contract Giver along with the information received from supplier to proceed for recall of the product. | |
| 5.2.7 | The details of defective API will include:
—Batch no of API. —Batch no of finished product & total batches affected. —Reason of failure. |
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| 5.2.8 | Manufacturer shall also inform the DMRC regarding the defective API supply with details mentioned under Section 5.2.7. | |
| 5.2.9 | A written status of product recall shall be forward to Director for approval with category to be mentioned. | |
| 5.2.10 | Director shall approve recall decision. | |
| 5.2.11 | If the product recall is approved, the same shall be intimated to the plant Head for recall operations. | |
| 5.2.12 | The information shall be given to all Regulatory Authorities (local and of all countries to which products may have been distributed) if products have been decided to be recalled because they are suspected of being defective. The DMRC (Defective Medicines Report Centre) shall be intimated for the action taken and updated with recall process. | |
| 5.2.13 | Intimation to the Logistics Manager for the recall operations along with the product details shall be given. | |
| 5.2.14 | Recall Documents | |
| 5.2.14.1 | Manager (Logistics) shall ensure that an up to date list of all the emergency contact numbers and the product details are immediately available | |
| 5.2.14.2 | The distribution records shall be readily available to the Manager (Logistics) for recalls, and shall contain sufficient information of wholesalers and directly supplied customers (with addresses, phone and/or fax numbers, inside and outside working hours, batches and amounts delivered), including those for exported products and medical samples. | |
| 5.2.14.3 | Logistics Department shall assign a Recall number to each recalled product which shall be referred in all correspondence. | |
| 5.2.15 | Public announcements | |
| 5.2.16 | Logistics Department shall implement the required depth of recall of distribution from which a product is recalled, i.e. wholesale, retail, user/consumer and start the process by recall notification to accredited wholesalers/ Physicians/ Pharmacies/ Retails outlets/ Hospitals to return all unsold stock and get return feedback. If required, product recall information shall be given on Media Network (Radio or, Television). | |
| 5.2.17 | Recall Closeout | |
| 5.2.17.1 | The Head of Marketing along with Logistics Manager shall ensure that all unsold stocks at all levels viz. stockist, distributors, retailers are immediately quarantined and returned to warehouses for further action. | |
| 5.2.17.2 | All stocks of the recalled products at Warehouses shall be identified and stored separately in a secure area while awaiting a decision. | |
| 5.2.17.3 | Complete reconciliation between the delivered and recovered quantities of the products shall be done as per Annexure and forwarded to the Plant Head/Head QA for information. | |
| 5.2.17.4 | A detailed investigation of the recalled batch shall be carried out and the reason for quality failure shall be evaluated and preventive action shall be initiated to avoid reoccurrence of such failure. | |
| 5.2.18 | Mock Recall | |
| 5.2.18.1 | A dummy recall exercise shall be conducted through the “Dummy Letter of Recall” as per Annexure once a year. The dummy recall can be performed either by the Contract Giver or the Contract Acceptor in association with the Contract Giver, to cover up the entire chain of distribution. The recall lead time along with percentage of goods recalled shall be recorded to ensure effectiveness of the procedure. | |
| 5.2.18.2 | If the dummy recall exercise is carried out by the Contract Acceptor, then the Logistics Manager will inform the Contract Giver the details of the batch by telephone and the reason for recall and will email the recall form to the Contract Giver. | |
| 5.2.18.3 | Contract Giver will than arrange to collect details of available stock at each distribution point and will intimate to the manager (logistics) of Contract Acceptor. | |
| 5.2.18.4 | The details will be forwarded to the Recall Committee for review. | |
| Note:
The procedure shall be reviewed after every recall event and reviewed as necessary. This procedure shall not be applicable where recall advice is not received from Contract Giver. Contract Acceptor shall carryout the dummy recall only when the product is directly distributed by him to the distributors/ suppliers. |
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- Abbreviation:
| Abbreviation | Expansion |
| i.e. | Id Est. |
| API | Active Pharmaceutical Ingredient |
| DMRC | Defective Medicines Report Centre |
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