Product Recall Procedure

1.0 OBJECTIVE

To lay down a procedure for requirements concerning the conduct for recall of the product in case of complaint, regulatory notice and discrepancies found after dispatch.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at XXX, Company.

3.0 RESPONSIBILITY

3.1 Managing Director

3.2 Head-Marketing

3.3 Head-Quality Assurance

3.4 Head-Quality Control

3.5 Head-Warehouse

4.0 PROCEDURE

4.1 A recall is defined as the Company's removal of a marketed product because of design or production defects that may compromise safety, efficacy and purity of the product or because of Government regulation.

4.2 A recall of a marketed product will be instituted when either the product is suspected or proven to be defective based on stability study, market complaints, assessment of likelihood occurrence of the hazard or if directed by the Drug Control Administration, Andhra Pradesh or health / regulatory authorities (RA) of the country where the product is marketed.

4.3 When the above criteria met as mentioned in 4.2, Head Quality Assurance shall immediately call for a meeting of the recall committee and discuss about the criticality of the defect.

4.4 In case, the Drug control department asked to recall the product, The Head QA or his designee shall contact the complainant directly to verify the nature of the product defect.

4.5 A recall committee shall be set up, consisting of (Annexure-1)

4.5.1 Head - Marketing

4.5.2 Head - Production

4.5.3 Head - Quality Assurance

4.5.4 Head - Quality control

4.5.5 Other (s) as considered appropriate

4.6 The Head-Quality Assurance shall act as Chairman and Coordinator of all recall activities.

4.7 The review team shall classify the recalls with numerical designation based on the product being recalled.

4.8 The recall classification shall be numerical designation, I, II or III, that is assigned to particular product recall that indicates the relative degree of health hazard by country regulatory authorities.

4.8.1 Class I – Is a situation in which there is a reasonable probability that the use of, or exposure to, a defective product will cause serious adverse health consequences or death and as well as drugs banned under 26A of drugs and cosmetics act 1940.

4.8.2 Class II – Is a situation in which use of, or exposure to, a volatile product may cause temporary health consequences or where the probability of serious adverse health consequences is remote.

4.8.3 Class III –Is a situation in which the use of, or exposure to, a defective product is not likely to cause any adverse health consequences.

4.9 Recall Procedures

4.9.1 Any batch of a product not meeting the defined quality standards has to be recalled from the market. Recall can be of two types; Voluntary Recall and Statutory Recall.

4.9.1.1 Voluntary Recall:

4.9.1.2 Voluntary recall can be triggered by any incident that affects the quality, safety and efficacy of the batch/product in question such as

4.9.1.2.1 If the batch or batches are found to be not complying with the regulatory specifications during the post marketing stability study.

4.9.1.2.2 If the batch is found to be defective during investigation of market complaint.

4.9.1.2.3 During any failure investigation, if it is observed that the failure under investigation might have adverse quality impact on already released batch (e.g. possibility of contamination, mix-up, degradation etc).

4.9.1.2.4 If any unusual observation is noted during visual inspection of retention samples which indicate an impact on quality of the product after investigation.

4.9.1.2.5 If the post marketing surveillance reports /pharmacovigilance reports indicates that there is serious safety risk associated with the product.

4.9.1.3 Statutory Recall

4.9.1.4 Statutory recall can be triggered in response to the direction or mandate by the Drug Regulatory Authorities (Central/State) in one or more of the situations as follows :

4.9.1.4.1 To recall the drug product/batch, considered to be in violation of the laws, it administers such as not of standard quality etc.

4.9.1.4.2 To recall the banned drugs.

4.9.1.4.3 Labeling and /Promotional materials that are considered to be in violation of law.

4.9.1.4.4 Product, violation Rule 106 (Diseases under Schedule J)

4.10 Levels of Recall

4.10.1 The level (or depth) of recall of a product/batch shall be determined based on recall classification and level to which distribution has taken place.

4.10.2 There are three levels of recall such as consumer/user, retail and wholesale.

4.10.2.1 Consumer or User Level: This may vary with product, including any intermediate wholesale or retail level. Consumer or user may include individual consumers, patients, physicians and hospitals.

4.10.2.2 Retail Level: - recall to the level immediately preceding consumer or user level. It includes retail groceries, pharmacies, hospital pharmacies, dispensing physician, institutions such as clinics and nursing homes, etc.

4.10.2.3 Wholesale Level: all distribution levels between the manufacturer and retailer.

4.10.3 All Class I recalls shall be executed to the levels of Wholesale/Distributors, retail, and consumer. In such cases, public announcements shall be made using print/electronic media aids viz. Newspapers, Television, Radio etc.

4.10.4 All Class II recalls shall be executed up to the levels of wholesale and retail. All Class III recalls shall be executed up to the levels of wholesale.

4.11 Time lines for Effective recall system and rapid alert

4.11.1 Based on the category of risks involved, a time line of within 24 hours up to a maximum of 72 hours for Class I recall, for class II recall up to a maximum of 10 days and for Class III recall up to a maximum of 30 days is allowed.

4.11.2 The time line for initiation of recall procedure to commence from the receipt of information as notified by the concerned State/ Central Drugs Control Department under statutory recall or voluntary recall by the manufacturer on its own.

4.11.3 The time line for stopping sale/distribution of defective product under Class I shall be ensured within 24 hours and the physical recall being completed within 72 hours. The Class II and Class III recalls shall be ensured up to 10 and up to 30 days respectively.

4.12 Procedure for Rapid alert & Recall System

4.12.1 As soon as the product/batch (es) to be recalled is/are identified, Head- QA shall review the information related to the defective product/batch (es) and decide about recall as per the procedure established.

4.12.2 The decision on recall of the defective product/batch shall be made within 24 Hours up to maximum of 72 Hours for Class I recall upon receipt of the intimation by recall committee.

4.12.3 Within 24 Hours of the decision taken for the recall of the product/batch (es) the communication shall be sent stating the severity of the defect, using the fastest mode of communication which may include email, telephone, fax, SMS etc to the entire supply chain.

4.12.4 The licensee/representative of licensee where the product is marketed shall inform the concerned regulatory authorities where the product batch (es) in question was distributed immediately after the decision of recall has been taken. Further actions on recall will be undertaken according to class of recall.

4.13 Recall Procedure for Domestic Market

4.13.1 The Quality Head shall enter the details in the ‘recall log’ (Annexure-2) and assign a unique recall reference number representing serial number for a particular year in which the recall has been initiated.

4.13.2 Quality assurance-Head shall inform the Distributor/Marketing Company with fastest mode of communication which may include email, telephone, fax, SMS etc. to stop further distribution of the batch(es) in the stock and call back the stock available with the distributors, retailers etc, depending on the seriousness of the defect.

4.13.3 The ‘Product recall circular’ (annexure-3) shall be filled and sent by Managing director to distributor or marketing company.

4.13.4 He will also instruct to stop further sales of the product of the said batch at every distribution / sales point.

4.13.5 They will have to be requested to reply to the company by filling the product withdrawal details’ as per Annexure-4.

4.13.6 However, in case of urgent recalls in addition to sending circulars immediate contact with concerned persons should be established by telephone, fax, email or any other available means.

4.13.7 QA Head shall monitor the recall process of product/batch to determine whether the recall is progressing satisfactorily as per annexure-5 in coordination with Head-Warehouse.

4.13.8 The stocks of recalled goods shall be placed under “Quarantine” and stored separately under lock and key in a secure area until further decision.

4.13.9 The return goods shall be handled by ‘Handling of return goods’ SOP.

4.14 Recall Procedure for Foreign Countries

4.14.1 The overseas agent / contract giver, where the product has been shipped shall be immediately intimated about the nature of defect in the product and its likely hazards with respect to general health by fax, mail and telephone. The overseas agent / contract giver shall initiate the recall in the respective country or as specified in the agreement / contract.

4.14.2 As the fail-safe policy, the dealer and or agent shall be instructed to intimate the wholesalers and retailers, where he has distributed the product about stoppage of use and return back all the stock back to him.

4.14.3 All the requirements of countries regulatory authority shall be completed jointly by Company as a manufacturer and contract giver or principal company as a distributor or licence holder.

4.14.4 After recalling the stock back to dealer, the arrangement shall be made to ship the recalled stock back to India or destroyed in the country where exported.

4.14.5 When FDA / regulatory authorities terminate the recall, recall reports are to be discontinued.

4.14.6 The progress of recall shall be recorded and the final report be issued including reconciliation between the delivered and recalled quality to the regulatory authorities of the country from where the product is recalled.

4.15 Root Cause Analysis

4.15.1 Analyze the root cause of the problem by raising the NCR as per SOP.

4.16 Corrective and Preventive actions

4.16.1 To prevent the reoccurrence of the problem in future take the necessary corrective and preventive actions as per SOP.

5.0 ABBREVIATIONS

5.1 FDA- Food and drug Administration

5.2 QA- Quality Assurance

6.0 ANNEXURE

6.1 Annexure-1: Recall Committee contact numbers list

6.2 Annexure-2: Recall Log

6.3 Annexure-3: Product Recall Circular

6.4 Annexure-4: Product withdrawal details