Product Recall SOP

 

1.0              PURPOSE:

To lay down procedure for prompt and effective recall of finished products known or suspected to be defective, from market.

2.0              SCOPE:

This SOP is applicable to all the product recalls, manufactured in the Formulation plant -----------------------

3.0              RESPONSIBILITY:

3.1              Quality Assurance                   : Decision for recall    

: Reviewing status of recall

3.2              Head QA                                 : Initiation for product recall

: Communication to concerned departments

: Initiation of investigation

: Product Review (current & other manufactured batches)

: Ensuring batch recalled is quarantined          

3.3              Distribution Department          : Provide distribution list

: Facilitating recall from all distribution points

: Ensuring stoppage of further sale & distribution of suspected                                              batches                      

3.4              Manager stores                         : Storage of recalled goods

: Destruction of recalled goods                  

 

4.0              ACCOUNTABILITY:

The Accountability lies upon Quality Assurance Head for implementation and complies of the SOP.

5.0              PROCEDURE:

5.1              DEFINITION OF RECALL:

5.1.1        Removal from the market of the specified batches of a product/ entire product.

5.1.2        Any written communication received from complainant (Distributor/ retailer / stockiest / Field staff / customer / doctor) regarding the defects in product quality (purity, efficacy and any adverse drug reaction) including its physical characteristics, packaging, labeling etc. shall be investigated as per “SOP on handling of market complaints”

5.2              A product shall be recalled in following cases:

5.2.1        When there is market complaint and on investigation it is essential to recall the product as the product may cause serious adverse effect.

5.2.2        When during Control Sample Observation, it is observed that there is degradation in product and it may cause serious adverse effect.

5.2.3        In case any problem is observed during stability of any of the product.

5.2.4        In case any critical labeling error or any critical formulation error.

5.2.5        Any notification from Drug Control Authorities regarding the quality of a product.

5.3              Prior to approving a recall, the top management shall review the need for a recall with the client company representative. For this purpose a complete description of the possible recall situation is required including but not limited to the following:

5.3.1        Name of Product involved and Batch number.

5.3.2        Description of potential problem and how discovered, e.g. product complaint (including number of complaint), failure in testing or audit.

5.3.3        A summary of the quantities involved, i.e. original quantity, quantity held, quantity released and quantity distributed.

5.3.4        Report of any action or investigation undertaken at local level.

5.3.5        Copies of any correspondence with local regulatory agencies.

5.3.6        Rationale for proposed recall including proposed method and depth of recall.

5.4              The following procedure outlines actions required for recall:

5.4.1        Any employee who becomes aware of a possible need for a recall will advise their supervisor, who will notify the management.

5.4.2        The plant manager will instruct the distribution department and individual stockiest for stopping further distribution of products. The process will continue till retailer.

5.4.3        The plant manager will either notify the top management in case of a local government enforced / mandated recall or request approval of the top management as per the format number F/QA-015-01.

5.4.4        After reviewing the need for a recall the top management and client company representative will communicate the decision, including specific recall implementation instructions to the Plant Head. The Plant Head will notify the appropriate regulatory agencies, if required by local health regulations.

5.5              When a product needs to be recall from market it must be determined what classification it must receive. Find out the seriousness of health hazards caused by the product and its consequences. The seriousness shall be classified as:

Class I- Class I is a situation in which the consequence of use or exposure to the product are life threatening or involve in a serious adverse health consequence. This class of defects required recall within 24 hours.

Class II- Class II is a situation in which the use of, or exposure to, a violation product may cause temporary adverse health consequence or where the probability of serious adverse health consequence is remote. This class of defects required recall within 72 hours.

Class III- Class III is a situation in which the use of, or exposure to, the product is not likely to cause adverse health consequence. This class of defects required recall within 5 Days.

5.6              The form shall be forwarded to Head-QA and Plant Head for approval.

5.7              The reasons and conditions of the product recall and its class shall be discussed by Head QA with Plant Head, Regulatory, Marketing and Qualified Person (QP- wherever applicable). An action plan shall be prepared by this group.

5.8              If the product batches to be recalled are from the regulated markets, necessary communication will be sent by Head QA or QP to the respective Regulatory Authority, after consulting Regulatory Affairs.

5.9              The Product Recall shall be initiated promptly no sooner the decision is taken by Head QA. Necessary communication shall be sent to all concerned within the shortest time period, but not later than 72 hours in case of Class I and Class II.

5.9.1        The Distribution record shall be checked by Head QA in consultation with Distribution Department to identify the destinations, the quantities, batch number-wise.

5.9.2        Head – QA shall advise Distribution department and Marketing department to instruct the distributors and stockiest to stop further dissemination and sale of the product batches.

5.9.3        The communication can be sent by telephone, email, fax, and any other faster mode. Where required this may also be put on news media, but only in case of Class I recall.

A follow-up on the communication and response to it shall be monitored by QA, Distribution and Marketing department.

5.9.4        Necessary arrangements shall be administered by the Supply chain to receive the recalled product batches’ quantities. The returned stock shall be reconciled to the closest quantity of actual distribution.

5.9.5        This reconciliation shall consider all unit or pack of batches under recall even from hospital and pharmacy stores. The batch documentation and reconciliation shall be thoroughly scrutinized by competent personnel from QA, Distribution and Marketing departments.

5.9.6        In the likelihood of possibility of destruction of stocks in the country of market, the Head – QA and QP shall delegate responsibility to the supply chain to do so with the permission of the local Regulatory authority.

5.9.7        The returned/ recalled stocks shall be destroyed as per SOP on Rejection and destruction policy of drug products and its components.

5.9.8        All records and communications related to Product Recall shall be properly maintained by the respective departments, such as Distribution department, Marketing department and QA as per Annexure QAGN016/A02. These records shall be reviewed by QA for adequacy and accuracy.  

5.9.9        The local Drug Control Authority shall also be informed of such recalls by QA.

5.10          When there is need for recall of any product, it is initiated by QA Head. Quality Assurance Head shall make the entry in to Product Recall Log Format No.: F/QA-022-02 and allot it a Product Recall Number e. g. PR/18/001, It is allotted as PR/XXYYY

            Where.....                    

                                    PR - Product Recall Number.

                                    XX - current year like 18 for this year.

                                    YYY – Serial Number of the Product Recall.

5.11          QA Head shall then fill the Product Recall Form in Format No.: F/QA-022-01. This includes Product Recall No., Product Name, Batch No., Mfg. Date, Exp. Date, Market Complaint No. if any, reason for recall and names and addresses of persons recalled from.

5.12          The distribution records shall be readily available to the QA Head for recalls, and these records shall contain sufficient information on 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. Send the recall notification to the party/vendor on company letter head with the following details:

5.12.1    The Product Name, strength, pack size

5.12.2    Batch No.

5.12.3    Reason for Recall

5.12.4    Further action required by them

5.13          The QA Head along with Head marketing & Distribution shall implement the recall without delay.

5.14          Recall shall be completed with in 45 days of initiation.

5.15          Recalled products shall be identified and stored separately in a secure area in Finish Goods Store while awaiting a decision on their fate.

5.16          In case if the product belongs to third party or loan license, the QA of respective party shall decide whether the product shall be destroyed or reprocessed.

5.17          Verify that CAPA system procedure that address the requirement of the quality system   regulation have been defined and documented.

5.18          Determine if appropriate sources of product and quality problem have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problem that may require corrective action.

5.19          Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problem that may require preventive action.

5.20          Challenge the quality data information system .Verified that the data received by the CAPA system are complete, accurate and timely.

5.21          If the product has to destroyed it shall be done in the manufacturing premises & If the product is reprocessed then it shall be kept for stability.

5.22          The progress of the recall process shall be recorded and a final report issued, including reconciliation between the delivered and recovered quantities of the products. The recall close out report will be shared with the regulatory authorities, third party or loan license party.

5.23          The effectiveness of the arrangements for recalls shall be evaluated from time to time.

6.0              LIST OF ANNEXURE AND FORMATS:

Sr. No.	Title of Format	Format No.
01	Product Recall Approval Form	F/QA-022-01
02	Product Recall Form	F/QA-022-02
03	Product Recall Log	F/QA-022-03
04	Product Recall Process Flow Chart	A/QA-022-01

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

7.4              SOP-QA-031

7.5              SOP-QA-008

7.6              SOP-QA-035

 

8.0              REVISION HISTORY:

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

9.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
1.	SOP	Standard operating procedure
2.	QA	Quality assurance

 

 

 1.0              Recall Initiation                   

Product Recall No.: (to be assigned by QA)				Date:
1.1	Product Name:		Market Complaint No.:
1.2	Batch Size:		Category:
1.3	Batch No.:	Mfg.:			Exp.:
1.4	Initiated By:				Market:

 

1.5	Reason for Recall:
1.6	Recall Details:			Batch number wise Total Quantities: Pack sizes: Distribution record verification: Distribution destinations:
1.7	Proposed Recall Plan:			Mode of communications: Information to Qualified Person and inputs: Information to RA and inputs: Information to Regulatory authority: Returned Goods Receiving point: Follow-up results:
1.8	Attachments / Supporting Data (if any):
Initiated by QA		Name			Signature		Date
2.0              Review by Qualified Person (comments):
Review by Qualified Person		Name			Signature		Date
3.0              Review by Head-QA (comments):
Review by Head-QA		Name			Signature		Date
4.0		QA Review / Approval			Approved		Rejected
5.0		Implementation of Product Recall
5.1		Dates of Recall communications: -       Stoppage of distribution & sale: -       Return of Goods:
5.2		Quantities returned and Reconciliation:
5.3		Recall process review done by (names & signatures) QA, Distribution, Marketing: ……………………………………………………………………………………………………………….., ……………………………………………………………………………………………………………….., ………………………………………………………………………………………………………………..,
Review by Qualified Person (where applicable)			Name			Signature		Date
Review by Head-Distribution			Name			Signature		Date

 

 

6.0              Decision Taken:	Reprocessing                Destruction
QA Head (Sign/Date): QA Loan License/Third party If Applicable
Destroyed on / Date:
Reprocessing done / Date:

 

Sr. No.	Reprocessing/Destruction  Details	Quantity	Done by /on	Verified by /on

 

Product kept for stability / Date: CAPA No. (If required)

 

7.0	QA Review of Implementation & Closure
7.1	Summary Report of Recall:
7.2	QA Comments on Reconciliation:
7.2.1	All Recommendations Fulfilled:                 Yes /            No
7.2.2	If No, Justification:
7.2.3	Data Generation Completed:                Yes /              No
7.2.4	If No, Justification:
7.2.5	Can the Product Recall Be closed? :                Yes  /             No
7.2.6	Remarks (if any):
Closure Approved by Head-QA		Name	Signature	Date

 

 

 

 

 

 

 

 

 

 

END OF DOCUMENT