Procedure for Product Recall.

1.0	PURPOSE To establish the procedure to discontinue distribution and sale of batch of a product and retrieve (Recalled) unsold stock of the batch under question from market promptly and effectively.
2.0	SCOPE This procedure is applicable for drug products manufactured by Company Name for domestic as well as Export market.
3.0	RESPONSIBILITY Head- Quality Assurance To investigate defective drug product and implement corrective action and preventive action. To co ordinate the recall by providing the required Details. Disposition of the recalled Product.
4.0	ACCOUNTABILITY Tech Director To receive and asses reports of suspected defective drug product. To advise and monitor necessary actions and recall and reconciliation. To communicate with relevant agencies.
5.0	PROCEDURE
5.1 5..1.1 5.1.2 5.1.3 5.2 5.2.1 5.2.1.1 5.2.2.2 5.3 5.3.1 5.3.1.1 5.3.1.2 5.3.1.3 5.3.1.4 5.3.1.5 5.3.1.6 5.3.1.7 5.3.2 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.5 5.6 5.6.1 5.6.2. 5.7 5.8 5.9 5.9.1 5.9.2 5.9.3 5.9.4 5.10 5.11 5.11.1 5.11.2 5.12 5.13 5.14 5.15 5.16 5.16.1 5.16.2 5.16.3 5.16.4 5.16.5 5.17 5.18 5.18.1 5.19 5.20 5.21 5.22 5.22.1 5.22.2 5.22.3 5.22.4 5.22.5 5.23 5.23.1 5.23.2 5.23.3 5.23.4 5.24 5.25 5.26 5.27 5.28 5.29 5.30 5.31 5.32 5.33 5.34 5.35 5.35.1 5.35.2 5.35.3 5.36 5.37 5.38 5.39 5.40	Definition: Defective drug product During the manufacturing or distribution of drug product, an error or incident may occur whereby drug product does not conform to its specification or is for some other reason is defective (e.g. presence of a contaminant which may not be detected during routine analysis). While such a defect may impair the therapeutic effect of the product and could adversely affect the health of the patient. Withdrawal: The drug products take back from the market. Recall Removal of a specific batch (es) of the drug product. Recall decision: Drug product shall be recalled in case, Forced recall (can be due to Instruction from Regulatory or health authorities). Voluntary recall. Voluntary recall may due to following reason (s) ·         a) Product Mix-ups ·         b) Non –conforming results of  ongoing stability study ·         c) Labeling errors ·         d) Damage of containers / closures holding the products during storage / transit ·         e) Excess supply to the customers ·         f) Market complaint ·         g) Expired Product ·         h) Minimizing the regulatory involvement ·         i) Any other reasons Tech Director shall nominate the person for initiating investigation, coordination and product recall. An investigation for correctness of reported defects shall be carried out independently by Head- QA, Head- Production supported by Head – Marketing and Distribution. The investigation shall cover but not limited to: Control sample (Inspection and if required analysis) Stability study data Transpiration, distribution & Storage Consumption & usage by user Pre and Post batches manufactured Product with same formulation type Same product with different strengths In case of either of recall (forced or Voluntary) Tech director shall assess the situation / complaint / Instruction. Classification of Recall Based on the investigation data Head QA shall categories the recall- Class-I The defect presents a life threatening or serious risk to health. Class –II The defect may cause mistreatment or harm to the patient, but it is not life threatening. Class-III The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non compliance with the marketing authorization or specification. Class IV Where there is no threat to patient or no serious defect likely to impair product use or efficacy. There are generally used for minor defects in packaging or other printed materials. They can be called as “Caution in use” defects. For investigation and further action following details shall be made available by concern department head, agency, and personnel authorities. a) Product details b) Brand name c) Strength d) Pack size e) Batch No. / Lot No. f) Manufacturing date / Expiry date g) Any other details identifying the product / batch h) Mfg license No. i) Actual sample pack or photocopy j) Nature of defect Tech Director and Head – QA  shall jointly investigate the defect with respect to : Nature and genuineness of defect. Causes of defect (if not clearly identified probable cause). As and when required head QA shall seek the details, data, document form Location, Regulatory, Marketing and Distribution and other concerned departments. On the basis of investigation Head-QA shall suggest for classification product recall. Product recall shall be initiated in case of justified reasons like: The drug product proves to be harmful under normal conditions of use. The drug product is lacking in therapeutic efficacy. Qualitative and quantitative composition of the product is not as declared. The control on the drug product and / or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled. Head- QA shall forwards the observations and suggestions for product recall to Director/Tech.Director. Once the product recall is authorized by director/Tech. Director, Head –QA  nominated for the product recall shall inform head- marketing and  distribution to: Discontinue distribution / sale of product.Retrieve unsold stock from market and under transit. Action to be taken (within time frame/ immediately) to quarantine stock/ return stock. Both the objective shall be served by sending suitable communication to company distributors, wholesalers, field staff, agents through by Head- marketing and distribution. Records of distribution shall be used for sending recall notification as per Annexure II. For Domestic Recall- The distribution details of the batch shall be available from distribution record(hard copy / software as applicable).For reconciliation of other batches data can be available from the record of distribution depot stock, plant warehouse stock from electronic software, WIP stock from  BPR. For recall by contract Givers- Distribution detail of the batch will be available with Contract giver by their own system. If information is received from Contract giver for reconciliation of other batches, data can be available from the record of depot stock, plant warehouse stock from electronic software, WIP stock, from bath manufacturing record. Recall notification shall include: Recall details a) Nature of recall b) Recall class-I/II/III/IV c) Level of recall (distributor level, retail level, pharmacy  , user level) d) Reason for recall e) Date of recall or withdrawal Volume of recall a) Quantity  manufactured b) Quantity consumed/ retained / under hold c) Quantity Distributed d) Estimated quantity in market (distributor level, retail level, pharmacy, user level) Product Details a) Brand name b) Strength c) Pack size d) Batch No. / Lot No. e)  Manufacturing date f)  Expiry date g) Any other details identifying the product/ batch h) Product license (PL Number), if applicable i)  Packing details(Product labeling) j) Actual sample pack or photocopy k) Promotional material(if applicable) l)  Nature of defect. m)Details of defects n) Direction of use/ Route of administration o) The account of any action taken in consequence Recalling firm details a) Name(s) of firm b) Contact person along with contact number (office hours and off hours) c) Firm address, city, state,country, zip code Distribution details (names/address/city/state/contact name/phone number) a) Wholesalers b) Distributors c) Re-packers d) Retail / pharmacy / veterinarian, e) Users / customers, (medical, hospitals, clinics, laboratories) f) Government Consignee g) Foreign consignees (specify whether they are wholesale distributors, retailers or users) h) Geographic areas of distribution, including foreign countries. Head- QA shall be forward all above details to all concern personnel, authorities, agencies and departments through mail, fax, telephone or by any other means Recall Strategy: Based on observation, investigation and above information Head-QA shall decide the recall Strategy. The strategy shall include a) Method of notification b) Notification to Regulatory Agency/ Authority(Local/ Export Country) c)  Notification to contract giver d) Mechanism of recall e)  Impact on the consumer(if this recall will create a market shortage that will) f)  Recall effectiveness check g) Course of action for out of business distributors h) Possible ways of addressing the defect i)  Disposition of recalled Product Head Marketing and distribution (Local/Export) shall immediately arrange to freeze All stocks of the specified Product/ Batch lying with distributors, agents, Customers. Head Market shall also instruct the entire sales force to freeze further sale of  product / batch at every distribution, sales point (stockiest, chemist, doctors, Hospitals etc.) This also shall include goods under transit. Head Marketing and distribution shall send a product recall circular immediately upon receiving the product recall notification to all concern persons requesting them to all stock of the product / Batch under question to the depots and informing them that a credit note for the stocks returned shall be issued to them at the earliest. Notification: Based on recall details and recall strategy head-QA shall decide the method of notification. This is get the massage accrues to the relevant consumers quickly enough to minimize the risk of injury. Notification shall include the Details as stated above. For notification one or more of (or any combination thereof) following shall be considered. Publicizing recalls in newspaper & printed media a) Advertise in daily or community news paper b) Display sign in retail outlets for the product. c) Issue a media release to newspapers. d) Ask relevant industry and community organizations to publicize the recall in their newsletters. e) Advertise in special interest publication if appropriate Recall notification shall be Clear & Bold      Recall      Notification ____________________________ ____________________________ ____________________________ ____________________________ For Company Name Sign / Date Electronic communication Media:                Advertise on radio and television. To assure the broadest coverage, press release should be issued through the associated press. Posting the recall notification on the web site. Notification is by phone. In case of recall as per directives of competent or Regulatory Authorities, the information shall be forwarded to them. Complete Reconciliation of stock of the batch manufactured / distributed and subsequently quantity of stock received back shall be intimated to Competent / Regulatory Authorities. In case of recall initiated by our company (voluntarily), this shall be informed to the Regulatory Authority. In the event of recall is initiated by Contract Adopter, the initiation of the same shall be forwarded to the authorization person  of Contract Giver by the Technical Director. In the event of recall is initiated by Contract giver, the intimation has to be given to Contract Acceptor by the authorized signatory of Contract Giver. The Contract Giver shall take the required action for the recall and intimate the quantity of goods received from the market. In case of Contract Giver product recall, the report of Contract giver and contract adopter will be co related and a compiled report of reconciliation shall be made. This report shall be kept by both contract giver and contract adopter. The record of the disposal of recalled goods shall be taken mutually by the Contract Giver and Contract Adopter. The records of the disposal of recalled goods shall be retained at both ends. The decisions, activities and actions including progress of recall shall be documented and duly authorized. On completion of recall procedure, summary report shall be prepared which shall include the following reference Reason for recall of a product (with batch no. and other details about the product). Effectiveness of recall. Corrective action to prevent recalls. Total cost incurred due to recall. This summary report shall be prepared by Quality Assurance Head as per Annexure III and be circulated to all concerned departments (Production, Finance, Sales) and the Managing Director, Tech. Director. In case of regulatory originated recalls the former closer shall be done only after receipt of final report from regulatory authority. Refer annexure I closure of product recall. The effectiveness of the system of recall shall be evaluated at least once in a four years or whenever the distribution chain is changed by MOC Exercise. The MOC Exercise shall be done by coordination with Head Marketing.
6.0	REFERENCES      cGMP Guideline

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	PRODUCT RECALL / WITHDRAWAL	QA/022/F01-00
Annexure II	RECALL NOTIFICATION (SPECIMEN)	QA/022/F02-00
Annexure II	SUMMARY REPORT OF RECALL / WITHDRAWAL	QA/022/F02-00

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
MOC						Maintenance operational check
BPR						Batch Processing Record
CQA						Corporate Quality Assurance
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Deptt.
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 2							Head Production (Tablet) Deptt.
Controlled office Copy No. 3							Head Production (Liquid) Deptt.
Controlled office Copy No. 4							Head Production (External) Deptt.
Controlled office Copy No. 5							Head Production (Soap) Deptt.
Controlled office Copy No. 6							Head  Sale & Distribution
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

                                                               

Annexure I

PRODUCT RECALL / WITHDRAWAL

To:  Tech. Director / Managing Director.

Kindly approve recall / withdrawal of the following batch(s) of products from market.

Details of the product:

Product:                                   B. No.                          Mfg. Date                    Exp. Date

Location of Mfg.                                                         Pack size:                     Batch size       

Type of recall: directives from Drug authority / Voluntary

Reason for Recall (Nature of defect)_________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

Approval for action: Recall / Withdrawal / Reprocessing / Destruction Recommended

Recommended by: _________________ Verified by: _________________________

Head –Quality Assurance                    Technical Director

Date:                                                             Date:

            *Marketing / distribution – For action

Information forwarded to: Manufacturing / CQA

Annexure II

RECALL NOTIFICATION (SPECIMEN)

Ref. No.______________________

Recall No._______________________

Date of Recall____________________

To: Accredited wholesalers

Kindly note that: following batch(s) of the product is being withdrawn from the market due to technical reasons. The details of the batch as mentioned below:

You are requested to collect all the stock sold by you to retail outlets and return it to the respective depot from where you have received the stock along with the unsold stock lying with you. After receipt of the stock, free equal replacements will be given to you whole executing your next order. Incase you do not have any stock pertaining to the above batch number with you, we will appreciate if you can write a confirmatory letter to this effect to our depot with a copy to us.

This is to inform you that we are withdrawing ______________ Batch No.________

 Product Name                   :                                     Batch / Lot No.            :

 Main Therapeutic Class    :                                     Mfg. Date                    :

 Pack Size                          :                                     Exp.Date                     :  

                                                                                 Batch Size                   :

Reason for Recall              :

(Nature of defect)

Action to be taken             : Collection at Depot / Returned to Factory

Urgency of Action            : (Time frame)

Annexure III

Summary Report of Recall / Withdrawal

Product: _____________                       Batch No.:________________

Mfg.Date_____________                       Exp.Date.:________________

Reason for Recall (Nature of Defect):__________________________________

_____________________________________________________________________________________________________________________________________________________________________________________________________________________

Recall No.:_______________

Date:____________________

Quantity Distributed:_______________________________________________________

Feed Back from Depots / Distributors / Wholesalers / Customers etc._______

______________________________________________________________________________________________________________________________________________

Action Taken for returned goods:_____________________________________________

_______________________________________________________________________

Total cost incurred due to recall:_________________________________

Corrective action taken to prevent recurrence:__________________________

_______________________________________________________________________

Reported by head of Quality department:_____________________________

_______________________________________________________________________

Date:___________________

Circulate to: 

  Tech. Director

                                                                 Director

           Managing Director