Handing of Product Recall

1.0 OBJECTIVE:
1.1 To lay down a procedure for product recall and handling of recalled products.
2.0 SCOPE:
2.1 This Standard Operating Procedure is applicable for recall of drug products and handling of recalled drug products manufactured at…..

3.0 RESPONSIBILITY:

3.1 Head-Quality Assurance shall be responsible for the coordination of product recall, final disposition of recalled product and correspondence of recall with the drug authorities.
3.2 Head Warehouse shall be responsible for providing the relevant information to the Head of Quality Assurance and execution of the product recall activity. He shall also be responsible for handling of recalled products as per this SOP.
3.3 Plant Head / Director(s) shall be responsible for final approval and authorization for the product recall.

4.0 ACCOUNTABILITY:
4.1 Store Head /Plant Head/Director/ Head QA

5.0 PROCEDURE:
5.1 On receipt of any complaint on the product safety, efficacy, purity, identity, quality etc. the same shall be investigated as per the SOP titled “Handling of Market Complaints.” During the course of investigation and assessment of degree of seriousness of health hazard to population if it emerges that the product is defective (or) and if company undertakes a voluntary recall or recall directed by the regulatory body(s), then the below mentioned procedure shall be followed.
5.2 Head-Quality Assurance shall initiate the form ‘product Recall-Investigation & Disposition ‘(Annexure-1) by filling product details, name of the committee members (HODs of concerned departments to be provided by Head-QA) and nature of the product complaint/defect.
5.3 Each Product Recall shall be assigned a eight character number PR/XX/YY where:

PR : Stands for Product Recall

/ : Slash

XX : Denotes year of product recall i.e.19 for the year 2019, 20 for the

— year 2020 etc.

A new series shall commence at the beginning of New Year.
/ : Slash
YY : Denotes serial number of the product recall i.e.01, 02, 03,…….99 etc. A new series shall commence at the beginning of New Year.
e.g.: A Second product recall for the year 2019 shall be written as PR/19/02.
5.4 Any batch of a product for which partial distribution has already begun and there is a product defect, the remaining quantity, if any, shall be put under HOLD by Quality Assurance till the committee takes a final decision.
5.5 Head-Quality Assurance shall coordinate with other members of the committee for investigation of product recall/defect & degree of health risk involved. Depending on the investigation, the committee proposes that the product shall be recalled or not.
5.6 The committee shall ascertain the severity of complaint, level of distribution of the product to be recalled & time frame for product recall. ‘Guideline for Categorization of Defects in Products and Reasons for Recall (Annexure-2) may be used as a guideline for ascertaining severity of complaint and time frame for product recall.
5.7 Once the product recall has been decided the recall committee shall devise a recall strategy comprising the time required for conducting product recall. Refer column ‘Recall strategy in the form Product Recall –Investigation & Disposition’ (Annexure-1).
5.8 Recall Strategy: Depending on the product’s degree of health hazard and extent of distribution, the recall committee shall devise a recall strategy. The recall Committee shall specify level in distribution chain to which the recall is to extend. e.g. whether the product recall shall be up to the consumer level, Retailer level, distributor or wholesaler level etc. During the investigation of recall if it is found that product defect is so dangerous as to be life threatening then public announcement shall be made to reach retail outlets, hospitals, medical practitioners, and individuals users by means of mass media.
5.9 Final approval and authorization for a product recall shall be obtained from Plant Head /Director(s), refer form ‘Product Recall- Investigation & Disposition (Annexure-1).
5.10 Once the product recall has been decided, Head- QA on behalf of company shall inform the drug authorities regarding decided product recall with following details
▪ Product Name, Batch No., Batch Size, Manufacturing Date and Expiry Date
▪ Reason for recall.

5.11 The distribution records shall be checked / reviewed to list down the name, addresses and contact numbers of customers with quantities distributed to each distributor.
5.12 Further distribution, sale of the product shall be stopped immediately once recall has been decided.
5.13 All the concerned parties shall also be informed by letter to be posted under “Certificate of Posting”. If no reply is received from them within a period of fifteen days, then a reminder of the same shall be sent to them under “Registered Post”.
5.14 If required, media coverage including television, telephone, print media, radio, internet, etc shall be used for prompt propagation of product recall message.
5.15 Recalled products shall be received by Finished Goods Warehouse personnel. Finished Goods Warehouse personnel shall physically verify the details of the recalled products like Product name, Batch No., Mfg. Date, Expiry Date and pack. The product shall be stored in a designated area in the Finished Goods Warehouse while awaiting a decision on further course of action. Remaining stock, if any, of the suspected batch of the product in the warehouse shall also be moved into this secure storage area and entry to the area shall be restricted.

5.16 Reconciliation between the delivered and recovered quantities of the product shall be recorded on form ‘Product Recall – Reconciliation’ (Annexure-4) by Finished Goods Warehouse personnel and approved by Head- Warehouse and Head-Quality Assurance.
5.17 The concerned person from Finished Goods Warehouse shall handle the recalled products as per the decision taken by the committee [Refer form ‘Product Recall –Investigation & Disposition’ (Annexure-1)].
5.18 In case of product recall, the batch preceding and succeeding the recalled batch shall be investigated e.g. if batch number 10 of product is recalled, then the samples and documents of the batch number 09 and 11 shall be reviewed and proper investigation undertaken.
5.19 A internal audit may be carried out after reconciliation of recalled product to check the effectiveness of the product recall.
5.20 Recall committee shall finally review the complete recall operation including all documentation and Head-QA shall close the recall on form Product Recall Reconciliation

6.0 ABBREVIATION:

S. No.	Abbreviations used	Full form of Abbreviation used
1.	QA	Quality Assurance
2.	SOP	Standard Operating Procedure
3.	HOD	Head of department
4.	No.	Number

7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Product Recall – Investigation and Disposition
Annex-II : Guideline for Categorization of Defects in Products and Reasons for Recall
Annex-III : Address of the Drug control Authorities an Contract Customers
Annex-IV : Product Recall – Reconciliation
8.0 REFERENCE :