SOP ON PRODUCT RECALL AND MOCK RECALL PROCEDURE
PURPOSE : To define the procedure for drug product recall and mock recall.
SCOPE : This SOP shall be applicable to,
Hold and/ or recall of drug products from distribution or market due to certain non- confirmatory aspects or instruction from regulatory agency.
Hold and/ or recall of drug products sold in domestic and/ or export market.
REFERENCE(S)
WHO Technical report series No. 908 (2003), Annexure-4
PIC/s SOP: “Procedure for handling rapid alerts and recalls arising from quality defects”. 1st July 2004.
Drug and Cosmetics Act, 1940, Schedule-M
CROSS REFERENCE DOCUMENTS
- Change Control Management
- Corrective and Preventive Action (CAPA)
- Quality Risk Management (QRM)
- Handling, Management and investigation of Deviation
- SOP On Investigation
Attachment
- Product recall classification and associated actions with timelines.
- Format of product recall register (To be maintained at location.).
- Format of product recall register (To be maintained at CQA.)
- Format of product recall register (To be maintained at Logistics).
- Format of product hold and recall authorization request.
- Format for preparation of rationale for product recall.
- Format of letter to be used for Type A recall by logistics.
- Format of letter to be used for Type B recall by logistics.
- Format of recall effectiveness check letter to consignee.
- Format of recall effectiveness check response (Letter / e-mail method).
- Format of recall effectiveness check response (Telephone & personal visit method).
- Format of product recall periodic status / final report.
- Format of mock product recall audit report.
DEFINITIONS
Complaint: A market / consumer complaint is notification that a product in commercial distribution (which also includes physician sample).
May be in violation of the laws or regulations administered by the FDA (Drug Control Authority)
May have caused an illness, injury or death.
Is alleged to have caused problems not covered by the above.
Product Recall: A product recall may be defined as the retrieval from the marketplace of a batch (es) of a medicinal product as a result of a quality defect or other issue being identified with the batch (es) which resulted in the batch (est.) not to be in compliance with the terms of the product marketing authorization. In addition, a product recall may be warranted due to the emergence of new safety information relating to a product or class of products.
Correction: Repair, modification, adjustment, relabeling or inspection of product without physical removal.
Recalling firm / manufacturing location /Location: The firm who has produced / manufactured / marketed the product (under distribution or in use) being recalled.
Consignee (C & F agent / Distribution depot / Stockist) : Anyone who receives and further distributes the product.
Market withdrawal: A firms removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the food and drugs administration or which involves no violation, e.g. Normal stock rotation practices, routine equipment adjustments/repairs etc.
Stock recovery: A firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e. The product is located on premises owned by or under the control of the firm and no portion of the lot has been released for sale/use.
RESPONSIBILITY
Quality Assurance:
To recommend product recall.
To arrange for destruction of recalled product as per relevant SOP of location.
To ensure proper documentation of all the activities.
QA Head:
To authorize the hold and /or destruction authorization request and sent to CQA.
To monitor the activity as per product recall and any other relevant SOP.
To monitor implementation of CAPA as per the recommendation(s).
Plant Head :
To authorize hold and /or destruction authorization request.
To monitor the activity as per SOP.
To monitor implementation of CAPA as per the recommendation(s).
Corporate Quality Assurance(Marketing company):
To provide hold &/or recall registration number.
To review hold &/or recall authorization form.
To intimate logistics /international marketing for retrieval of product from market.
To monitor implementation of CAPA as per the recommendation(s).
Head Corporate Quality Assurance(Marketing company::
To decide on product recall request.
To ensure intimation to respective regulatory agencies.
To get verified the recalled quantity against the distributed quantity and reconciled with the quantity dispatched.
To communicate to R & D, if required.
To get mock recall performed for evaluation of effectiveness of the product recall procedure.
Logistics(Marketing company):
To hold the stock for further distribution at respective consignee.
To provide the stock available at respective consignee.
To retrieve the hold product at company’s depot / any other destruction location.
To intimate corporate quality assurance about retrieval.
Regulatory Affairs(Marketing company):
To provide guidance to location / international marketing for the recall of the exported product.
To get the recall process completed through international marketing for export
To communicate with regulatory agency regarding product recall and its progress for domestic recall.
International Marketing(Marketing company)::
Is a bridge between location / regulatory affairs and regulatory agency of the respective country.
To provide the product distribution &/or stock status information to location as and when requested.
To communicate to regulatory agency of the respective country to hold & / or recall of the product.
PROCEDURE:
Recall initiation:
Initiation of a product recall may be voluntary or Drug Control Authority requested or mandated.
Product hold and recall may trigger due to any of the below reasons:
On confirmation of quality complaint which may be from customer/ patient/ doctor/ regulatory agency /external sources or agencies. Examples of such complaints are following but not limited to:
- Melt back of lyophilized cake.
- Foreign matter.
- Colour change.
- Change in physical form of tablets, solution, and suspension.
- Adverse drug reaction/event.
- Product stability failure.
- Mislabeling observed.
- Counterfeit products.
Product recall classification:
Type A (PIC/s class I & II): Recall from consumer/ retailer / pharmacy / medical user / stockiest level where there is a risk to patient’s health.
PIC/s Class-I: defects are potentially life threatening or could cause a serious risk to health. A rapid alert notification must be sent to all parties, parties irrespective of whether or not the batch was exported to that country.
Examples of PIC/s-class I defects include following but not limited to.
- Wrong product (label and contents are different products).
- Correct product but wrong strength, with serious medical consequences.
- Microbial contamination of sterile injectable or ophthalmic product
- Chemical contamination with serious medical consequences
- Mix-up of some products with more than one container involved
- Wrong active ingredient in a multi-component product, with serious medical consequences.
PIC/s Class-II: Defects could cause illness or mistreatment, but are not class I. A rapid alert notification should be sent only to those parties to which it is known, or believed, that the batch has been distributed. In the case of parallel exports where there is difficulty in establishing the traceability of batches, consideration should be given to notifying all parties by the rapid alert system.
Examples of PIC/s-class II defects include following but not limited to:
- Mislabeling, e.g. wrong or missing text or figures.
- Missing or incorrect information (leaflets or inserts)
- Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences.
- Chemical/physical contamination (significant impurities, cross-contamination, particulates).
- Mix up of products in containers.
- Non-compliance with specification (e.g. assay, stability, fill/weight).
- Insecure closure with serious medical consequences (e.g. cytotoxic, child resistant containers, potent products).
Type B (PIC/s class III): Recall from stockiest where there is no risk to patient’s
PIC/s class-III: Defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons. If deemed relevant by the issuing authority, the rapid alert system may be used.
Examples of class III defects include following but not limited to:
- Faulty packaging, e.g. wrong or missing batch number or expiry date.
- Faulty closure.
- Contamination, e.g. microbial spoilage, dirt or detritus, particulate matter.
Timelines and actions associated with recalls:
The timelines and actions associated with the above classes of recalls are summarized in Attachment-I.
Hold, recall and destruction procedure for domestic products:
In case of product failure which may be due to any of the reasons, QA person shall make necessary entries in product recall register and shall inform to CQA through e-mail and shall collect product hold & recall registration number from CQA.
CQA shall make necessary entries in product hold & recall register.
Hold & recall registration number at CQA shall be defined as CHR/25/01 where CHR stands for hold and recall, 25 for year 2025 and 01 is serial number.
QA person shall send approved copy of “Product hold and recall authorization request” to CQA as per Attachment-V along with the rationale or investigation report containing rationale for hold/recall.
Note: investigation report must include Impact analysis: Inspection / analysis of samples of other batches and CAPA.
CQA shall review the request and shall take approval from head CQA for further actions depending upon the nature of the problem. Further actions may include following but not limited to:
Holding of the further distribution of the product batch.
Inspection / analysis of samples of different distribution locations.
Withdrawal of stock
Refusal of hold &/or recall request.
Head CQA shall comment / suggest / approve the recall authorization request.
Copy of the approved / commented request shall be sent to location QA department with copy to management, regulatory affairs and logistics.
If recommendations/comments given through mail, copy of the same shall be attached withhold & recall authorization request.
In case of approval of the hold and recall authorization request, CQA shall instruct logistics (with copy to regulatory affairs and Management though e-mail & phone if required) to hold and/or recall the batch(es) and to provide the stock status through e-mail, if required.
Logistics shall provide the stock status available at respective stockiest / C & Fs on the same day and make necessary entry in the product recall register..
CQA shall arrange to collect samples from different stockiest/C& Fs and shall send them to respective location for the inspection / testing (for critical quality parameters) if recommended in hold & recall request.
If required, a representative from concerned location may visit the respective Consignee(s) within 02 working days after receipt of stock status and withdraw the samples and arrange for analysis for further investigation.
In case of type B recall, if CQA has recommended sampling, inspection, analysis of samples of different distribution locations (Stockiest/C&Fs) , location shall take actions accordingly and shall send report to CQA having action taken, analysis results, impact analysis etc. within 03 working days after receipt of the samples at location (except products where biological assay is involved).
In case of rejecting the hold and recall authorization of the batch/es, proper justification shall be included by CQA head.
CQA head shall give instruction to logistics where to recall and destroy the batch in question.
In case of type A recall, logistics shall instruct different C&F /stockiest to recall the batch up to Stock list as well as dealers, distributors, wholesalers and retailer level through mail.
Logistics shall send the proofs of such communications & acknowledgments of the same received from dealers, distributors, wholesalers and retailer to concerned location with copy to CQA.
In case of type A recall rapid alerts to consumer level shall be given through television, radio, newspapers etc. in consultation with respective regulatory agency, if required.
In case of type B recall, Logistics shall instruct different C&F /stockiest to recall the batch up to Stockist level through mail . Copy of the e-mail or proofs of such communications shall be sent to concerned location with copy to
QA person shall ensure hold and recall of the product as per timelines.
QA person shall ensure that recalled product is stored at the designated area ensuring product security, storage condition and segregation.
QA person shall verify the quantity of recalled/recovered stock against hold stock status & shall make necessary entries in hold & recall register.
QA person shall arrange destruction of the batch as per relevant location SOP in the presence of QA. Destruction procedure followed shall be documented as per location SOP.
In case if the recall & destruction is recommended at any other destruction location, the same shall be done in presence of QA representative and necessary destruction details/procedure shall be recorded by location representative as per Attachment-II and relevant SOP.
Incase if recall is due to product complaint /nonconformity received from regulatory agency, CQA shall recommend necessary actions in consultation with regulatory affairs department. Any further communication to regulatory agency regarding investigation, product hold and/recall shall be done through regulatory affairs.
CQA shall monitor that hold and recall actions are taken as mentioned..
Hold, recall and destruction procedure for export products:
Procedure up to recall authorization approval by CQA head for the exported products shall be same as for domestic products.
CQA shall provide the relevant details to regulatory affairs for hold / Recall of the product in the impacted country (ies).
The recall information shall be submitted by Regulatory Affairs to respective country as per rules prevailing in respective country through international marketing.
Regulatory Affairs shall arrange for product hold and recall through international marketing with copy to location (recalling firm), CQA & Management.
The timelines for product hold and recall shall be as per Attachment-I.
Assessing Recall Effectiveness:
The purpose of effectiveness checks is to verify that all consignees have receive notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, mails or a combination there of.
CQA shall evaluate the effectiveness of the product recall procedure from the actual product recall or by performing mock recall and prepare the evaluation report.
Mock recall(s) shall be performed once in a year ± 1 month.
Procedure for mock product recall:
CQA shall collect following information /batch detail through mail for at least three products from more than one location.
- Product name & strength.
- Batch number.
- Manufacturing and expiry dates.
- Pack presentation.
- Total quantity of batch dispatched.
- Date of dispatch.
- Dispatched to.
Locations shall provide the requested batch details to CQA.
CQA shall inform to the head logistics to hold the stock of the selected products requesting the stock status at various Consignee (distribution depots and C & Fs).
Logistics shall hold the stock of the products and shall provide stock status at various Consignee (distribution depots and C & Fs).
CQA shall visit the two or three Consignee (distribution depots and /or C & Fs) and shall verify the stock of the product/s against stock status received from logistics head along with product storage condition and security of the hold product. The details of audit shall be recorded.
CQA shall prepare the mock product recall report and conclude the effectiveness of the recall.
CQA shall circulate the report to logistics as well as locations for record.
Procedure for effectiveness check of actual product recall:
Location shall perform recall effectiveness in consultation with either logistics department head or international marketing department head & regulatory affairs.
In conducting a recall effectiveness check, there are certain basic questions that consignees shall be asked either through letter/e-mail/ telephonically/ personal visit.
The purpose of these questions is to determine whether: the recall notification was received, the product involved was handled as instructed in the recall notification, the product was further distributed by the consignee before receipt of the recall notification, and if so, were these additional consignees notified. Other questions may need to be asked depending upon the nature of the recall. Also the design and format of the questionnaire may vary depending upon which method of contact is to be used.
Elements of these methods include following.
A letter to consignee.
An envelope prominently inscribed with “IMPORTANT RECALL INFORMATION INSIDE,”
A questionnaire, and
A self-addressed stamped envelope for the consignee to return the completed questionnaire.
The letter/ mail to the consignee shall state exactly the reason for the recall, a complete description of the product being recalled or corrected, and instructions as to disposition of the recalled product, and a request for cooperation in completing and returning the questionnaire.
Upon receipt of the completed questionnaires, a master file shall be prepared to identify responding consignees by their unique identification number and to record their answers to the questions.
Recall effectiveness check shall be completed within 35 working days of product recall at location.
Recall status reports/Recall final report:
Periodic status reports shall be prepared by the recalling firm on the progress of the recall effectiveness checks at biweekly intervals. These recall status reports shall contain following information:
Number of consignees notified of the recall, and date and method of notification.
Number of consignees responding to the recall communication and quantity of products on hand at the time it was received.
Number of consignees that did not respond.
Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.
Number of consignees contacted as per level and results of effectiveness checks that were made.
Estimated time frames for completion of the recall.
Corrective action plan.
In case of domestic product, these periodic status reports should be addressed to CQA & Management
In case of export product, these periodic status reports should be addressed to the respective regulatory agency, Regulatory Affairs, CQA & Management.
A final report on product recall shall be prepared including reconciliation between the delivered and recovered quantities of the products.
The report shall be sent to CQA for recall termination within 35 working days after product recall at location. The final report should include CAPA.
Correction and preventive Action Plan (CAPA) should include following
- Product description
- Consignee list (foreign and domestic).
- Description of the defect (including all reports, documents, memos, etc., of meetings, technical reviews, etc., which pertain to the analysis of the problem).
- Proposed steps to be taken to correct the product in the field and steps taken to prevent future occurrences.
- Proposed effectiveness checks to be conducted.
- Proposed date of completion and appropriate interim dates for implementation of the correction.
- Any and all injury/death investigations or reports.
Pertinent complaints on file.
If product recall is due to stability failure CQA shall intimate R & D and co-ordinate in resolving the product problem.
The recalling firm shall issue CAPA to concerned for the same.
Recall termination:
Termination of a domestic product recall: Type A / Type B
Upon receipt of the final recall report, CQA shall evaluate the same with respect to efforts put to recover the product; quantity delivered v/s quantity recovered and shall approve the recall within 03 working days after receipt of the report.
In case of type B recall, recall shall be terminated after ensuring recall of 100% quantity of the stock from consignee to location.
Termination of a export product recall:
Recall termination procedure shall be as per rule / law /guideline of the regulatory agency of the respective country.
Product destruction/corrections:
The recalling firm and customers shall keep adequate documentation of product destruction as per defined procedures.
Field corrections, (e.g. product relabeling), should be performed by recalling firm representatives, or under their supervision and control at a decided location.
Destruction Procedure of Recalled Product
The product returned from the market, shall be removed from its primary and secondary packing and recovered product shall be collected in SS container. Add sufficient volume of water with this recovered product and after getting it completely dissolved, check the pH, which should be more than 8 (If required use 1M NaOH to set the pH).Transfer this slurry in collection tank of ETP system.