Product Recall

Purpose

Product Recall-To lay down the procedure to discontinue distribution and sale of batch of a product and recall sold and unsold stock of the batch from market promptly and effectively.

Procedure

Preamble

Defective finished product:

During the manufacturing or distribution of product, an error or incident may occur whereby product does not conform to its specification or is for some other reason is defective. While such a defect may impair the therapeutic effect of the product and could adversely affect the health of the patient.

Product Recall Flowchart

Recall:

Removal or correction of marketed products for the reasons relating to deficiencies in Quality, Safety or Efficacy, including labeling considered to be in violation of laws.

Batch Recall:

Process for removal of selected batches of a product which are found to be defective and pose health risk to the consumers if left in the market.

Batch:  

A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.

Customer:

Any person, firm or party buying/receiving goods from the company for storage, distribution and sale.

Type of Recall:

Voluntary Recall

Statutory Recall

Voluntary Recall:

A recall initiated by the licensee as a result of abnormal observation in any product quality during periodic review (Internal / External) or investigation of a market complaint or any other failures.

Statutory Recall:

A recall triggered in response to the direction or mandate by the regulatory authorities (Central/State).

Recall Decision:

Finished product shall be recalled in case:

Statutory Recall:

• To recall the finished product/batch, considered to be in violation of the laws it administers such as not of standard quality etc. To recall the banned finished.
• Labeling and / or promotional materials that are considered to be in violation of the law.
• Product, Violation rule 106 (Diseases under Schedule J).
• Voluntary Recall:
• If the batch or batches are found to be not complying with regulatory specification during the post marketing stability study.
• If the batch is found to be defective during investigation of market complaint.
• During any failure investigation, if it is observed that the failure under investigation might have adverse quality impact on released batch (e.g., Possibility of contamination, mix-up, degradation, etc.).
• If any unusual observation is noted during visual inspection of retention samples which indicate an impact on quality of the product after investigation.
• If the post marketing surveillance reports/ Pharmacovigilance reports indicates that there is serious safety risk associated with the product.
• Any other reason.
• Head-QA shall nominate the person for initiating investigation, coordination and product recall.
• An investigation for correctness of reported defects shall be carried out by Head-QA, Head-FRD/ARD and Head-Manufacturing supported by Head-Marketing and Distribution.
• For investigation and further action following details (but not limited to) shall be made available by concern Department Head, Agency, Personnel or Customers.
• Product Name
• Batch Number
• Strength /Composition / Label Claim 
• Pack Size
• Mfg. & Exp. Date or Best Before
• Any other details identifying the product / batch
• Product license
• Actual sample pack or photograph
• Nature of defects
• Customer detail (if Any)
• Region The investigation shall cover but not limited to;
• Nature and genuineness of defect.
• Cause of defect (if not clearly identified probable cause) control sample (Inspection and if required analysis) stability study data.
• Transportation, Distribution & Storage
• Consumption & usage by user
• Pre and Post batches manufactured
• Products with same formulation type
• Same product with different strengths / Label Claim
• In case of either of recall (Statutory or Voluntary) Head-QA or Designee shall assess the situation / complaint/ instruction.
• As and when required  Head-QA or Designee  shall seek the details, data, document from Location, FRD, ARD, Regulatory Agency, Marketing and Distribution and other concerned departments.
• Product recall shall be initiated in case of Investigation concluded with reasons like:
• The finished product proves to be harmful under normal conditions of use.
• The finished product is lacking in therapeutic efficacy.
• Qualitative and quantitative composition of the product is not as declared.
• The  controls  on the  finished  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.
• On the basis of investigation observations, Head-QA or Designee shall classify of product recall.

Classification of Recall:

Based on the investigation data Head-QA or Designee shall categorize the recall as follows:

• Class-I
• Class-II
• Class-III

Class-I:

A condition 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 banned under 26A of Finished and cosmetics Act 1940.

Class-I recall shall be conducted within 24 hours up to 72 hours of receipt of intimation about the defect.

Class-II:

A condition   in which the use of, or exposure to, a defective product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Class -II  recall  shall  be conducted  within  10 days  of receipt  of  intimation  about  the defect.

Class-III:

A condition in which the use of, or exposure to, a defective product is not likely to cause any adverse health consequences.

Class-III recall shall  be  conducted  within  30 days  of  receipt  of  intimation  about  the defect.

Recall Committee:

• “Product Recall Committee” shall be prepared for further review of the matter and to identify the action plan.
• The Recall Committee and its members should be quickly convened when a Class I, II, or III situation exists.
• All information received and communication released regarding the recall should be approved by Head-QA.
• If the decision is that it is a Class I, II, or III recall, the Head-QA should immediately convene the Recall Committee. The Head-QA should then co-ordinate all recall activities, keeping the committee members informed.
• Head-QA/Designee shall forward the observations and suggestion for Product recall to Managing director / Director as Product Recall/Withdrawal Form. Based on observations and suggestion Managing Director / Director shall authorize the product recall.
• Once the product recall is authorized by Managing director / Director, Head-QA or Designee nominated for product recall shall decide the recall strategy.

Recall Strategy:

• Based on observation, investigation and above information Head-QA shall decide the Recall strategy. The strategy shall include.
• Method of notification
• Notification to Regulatory Agency/Authority (Local) Notification to contract giver
• Mechanism of Recall
• Impact on the consumer (if this recall will create a market shortage) Recall effectiveness check
• Course of action for out-of-business distributors
• Possible ways of addressing the defect
• Disposition of recalled product
• Head-QA or Designee nominated for product recall shall inform Marketing Head (Location), Marketing and Distribution to;
• To provide details of product / batch to be recalled i.e., Batch size, Quantity of product.
• Batch transfer to BSR, Quantity of product /batch transfer from location to CWH and further distribution details.
• 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.

Level of Recall:

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. There are three levels of recall such as Consumer/User, Retail and Wholesale.

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.

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.

Wholesale Level: All distribution levels between the manufacturer and retailer.

Details  of  recall  shall  be  shared  with  company  distributors,  wholesalers,  stockiest, retailers by Head-Marketing and Distribution or customer with recall notice .

Head Distribution shall forward “Summary Report of Recall” to distributor, wholesalers, stockiest, retailers and get the required information for stock reconciliation.

Records of distribution shall be used for sending recall notification. Distribution details will be available from following as the case may be;

For Product 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  ERP software,  WIP  stock  from  Batch Manufacturing Record and Batch Packing Record.

For Recall by Customer: Distribution detail of the batch will be available with customer by their own system. If information is received from customer for reconciliation of batches; for verification data can be available from the record of depot stock, plant warehouse stock software (If any), and WIP stock from Batch manufacturing record.

Head Marketing & Distribution shall immediately arrange to freeze all stocks of the specified product / batch lying with distributors, agents and customers.

He / She shall also instruct the entire sales force to freeze further sales of product / batch at every distribution, sales point (stockiest, chemists, doctors, hospitals etc.) This also shall include goods under transit.

Notification:

• Based on recall details, recall classification and recall strategy Head-QA or Designee shall decide the method of notification.
• This is to  get  the  message  across  to  the  relevant  consumers   quickly  enough  to minimize the risk of injury.
• For notification one or more of (or any combination thereof) following shall be considered:
• Publicizing recalls in newspapers & printed media.
• Advertise in daily or community newspapers.
• Display signs in retail outlets for the product.
• Issue a media release to newspapers.
• Advertise in retail flyers (E.g. Supermarkets, Retail Chains and Department Stores often send brochures to Householders).
• Ask relevant industry and community organizations to publicize the recall in their newsletters.
• Advertise in special interest publications if appropriate.
• Recall notification shall be clear & bold.

Electronic Communication Media:

• Advertise on radio and television.
• To assure the broadest coverage, press releases should be issued through the associated press.
• Posting the recall notification on the web site.
• Notification by phone / Social Media.

Recall Notification Shall Include:

Recall Details.

Nature of Recall (Withdrawal/ Recall).

Recall class (Class - I / II/ Ill).

Level of Recall (Distributor level, Retail level, Pharmacy level, wholesaler or user level).

Reason for Recall.

Date of recall or withdrawal.

Product Details:

Brand name Strength.

• Pack size.
• Batch No / Lot No /Manufacturing Date/ Expiry Date. / Best Before
• Any other details identifying the product batch.
• Product license if applicable.
• Packing details (Product labeling, individual package label, case label, package inserts).
• Actual sample pack or photocopy.
• Promotional material (if applicable).
• Direction of use / Route of administration.
• The account of any action taken in consequence.

Recalling firm details:

• Name of firm.
• Contact person along with contact number (office hours and off hours).
• Firm address, City, State, Zip Code.
• Head Distribution shall provide following details to Head QA or Designee to facilitate recall activities;
• Quantity Manufactured.
• Quantity Consumed/ Retained/Under Hold.
• Quantity Distributed.
• Estimated quantity in market (Distributor level, Retail level, Pharmacy level & User level).
• Distribution details (Names/Address/City/State/Contact Name/Phone Number).

Geographic areas of distribution.

Conditions for Recall:

In case of recall as per directives of competent or regulatory authority.

For products manufactured and  marketed  by our company, complete reconciliation of stock  of  the  batch  manufactured / distributed  and  subsequently  quantity of  stock received back shall  be intimated to competent / regulatory authority on request.

In-case of Voluntary Recall:

• When initiated for products manufactured and marketed by Pontika Aerotech Limited (Voluntarily), this shall be informed to the regulatory authority (as applicable).
• If required complete reconciliation  of stock  of the  batch manufactured / distributed  and Subsequently  quantity  of  stock  received   back   shall   be  intimated  to  Competent  / Regulatory Authority.
• The decisions, activities and actions including progress of recall shall be documented and duly authorized. Complete reconciliation of stock of the batch manufactured / distributed and subsequently quantity of stock received back shall be reconciled.
• On completion of recall procedure, “Summary Report of Recall” Shall be prepared which shall include the following
• This summary report shall be prepared by Head Distributor & forwarded to Head-QA  and Head QA Shall circulated to all concerned departments (FRD, ARD, Production, Finance, Sales) and the Managing Director / Director.

In the event of recall initiated by Principal:

• Principal shall take required action for recall and intimate the manufacturer about the recall.
• Note: In case of above two conditions the below procedure shall be followed:
• Principal shall intimate the manufacturer about the details of document required if any from manufacturer.
• Manufacturer shall provide the required documents to principal has requested.
• Principal shall intimate the manufacturer, the quantity of goods retrieved from the market.
• Principal shall provide the copy of report for recall to manufacturer. This report shall be kept by both.
• The decision of disposal of recalled goods shall be taken mutually by the principal and manufacturer.
• The records of the disposal of recalled goods shall be retained at both ends.
• In case of statutory recalls, the former closer shall be done only after receipt of final report from authority.
• Copy of recall document shall be preserved at QA department.

Mock Recall:

• The effectiveness of the recalls system shall be evaluated at least one batch of any product once in a year or whenever the distribution chain is changed in order to confirm the recall process will be executed effectively in case of actual product recall.
• In the event of actual product recall during this period of a year, the mock recall shall not be performed. The mock recall in such case shall be performed after every year from the date of actual recall.
• Head QA or Designee along with Head Distribution shall select the batch of product for mock recall considering batch which covers maximum distribution chain.
• Head QA or Designee shall prepare protocol for execution of mock recall. Protocol number shall be considered as reference number for mock product recall.
• On completion of mock recall, Head QA or Designee shall prepare a report for mock product recall. Based on the conclusion of mock product recall, head QA shall evaluate whether any change in procedure for product recall or modification in existing system of distribution procedure is required.