SOP for Product Recall

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.

This procedure is applicable for drug products manufactured by Company Name for domestic as well as Export market.

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.

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

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.

The drug products take back from the market.

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)
  1. Product Mix-ups
  2. Non –conforming results of ongoing stability study
  3. Labeling errors
  4. Damage of containers / closures holding the products during storage / transit
  5. Excess supply to the customers
  6. Market complaint
  7. Expired Product
  8. Minimizing the regulatory involvement
  9. Any other reasons

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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:
  1. Control sample (Inspection and if required analysis)
  2. Stability study data
  3. Transpiration, distribution & Storage
  4. Consumption & usage by user
  5. Pre and Post batches manufactured
  6. Product with same formulation type
  7. 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 categorize the recall:

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.

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 the 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.
  1. Product details
  2. Brand name
  3. Strength
  4. Pack size
  5. Batch No. / Lot No.
  6. Manufacturing date / Expiry date
  7. Any other details identifying the product / batch
  8. Mfg license No.
  9. Actual sample pack or photocopy
  10. Nature of defect

  • Tech Director and Head – QA shall jointly investigate the defect with respect to :
  1. Nature and genuineness of defect.
  2. 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:
  1. The drug product proves to be harmful under normal conditions of use.
  2. The drug product is lacking in therapeutic efficacy.
  3. Qualitative and quantitative composition of the product is not as declared.
  4. 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 productrecall shall inform head- marketing and distribution to:
  1. Discontinue distribution / sale of product.Retrieve unsold stock from market and under transit.
  2. 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(hardcopy / 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, frombath manufacturing record.
Recall notification shall include:

Recall details
  1. Nature of recall
  2. Recall class-I/II/III/IV
  3. Level of recall (distributor level, retail level, pharmacy, user level)
  4. Reason for recall
  5. Date of recall or withdrawal

Volume of recall
  1. Quantity manufactured
  2. Quantity consumed/ retained / under hold
  3. Quantity Distributed
  4. Estimated quantity in market (distributor level, retail level, pharmacy, user level)

Product Details
  1. Brand name
  2. Strength
  3. Pack size
  4. Batch No. / Lot No.
  5. Manufacturing date
  6. Expiry date
  7. Any other details identifying the product/ batch
  8. Product license (PL Number), if applicable
  9. Packing details (Product labeling)
  10. Actual sample pack or photocopy
  11. Promotional material(if applicable)
  12. Nature of defect.
  13. Details of defects
  14. Direction of use/ Route of administration
  15. The account of any action taken in consequence

Recalling firm details
  1. Name(s) of firm
  2. Contact person along with contact number (office hours and off hours)
  3. Firm address, city, state,country, zip code

Distribution details (names/address/city/state/contact name/phone number)
  1. Wholesalers
  2. Distributors
  3. Re-packers
  4. Retail / pharmacy / veterinarian,
  5. Users / customers, (medical, hospitals, clinics, laboratories)
  6. Government Consignee
  7. Foreign consignees (specify whether they are wholesale distributors, retailers or users)
  8. Geographic areas of distribution, including foreign countries.
  • Head- QA shall be forward all above details to all concerned 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
  1. Method of notification
  2. Notification to Regulatory Agency/ Authority(Local/ Export Country)
  3. Notification to contract giver
  4. Mechanism of recall
  5. Impact on the consumer(if this recall will create a market shortage that will)
  6. Recall effectiveness check
  7. Course of action for out of business distributors
  8. Possible ways of addressing the defect
  9. 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 concerned 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.

  • 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
  1. Advertise in daily or community news paper
  2. Display sign in retail outlets for the product.
  3. Issue a media release to newspapers.
  4. Ask relevant industry and community organizations to publicize the recall in their newsletters.
  5. Advertise in special interest publication if appropriate Recall notification shall be Clear & Bold

Electronic communication Media:
  1. Advertise on radio and television.
  2. To assure the broadest coverage, press release should be issued through the associated press.
  3. 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 Given 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
  1. Reason for recall of a product (with batch no. and other details about the product).
  2. Effectiveness of recall.
  3. 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.

cGMP Guideline


SOP: Standard Operating Procedure
QA: Quality Assurance
MOC: Maintenance operational check
BPR: Batch Processing Record
CQA: Corporate Quality Assurance


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