1.0 Purpose
1.1 To ensure recall of products that are known or suspected to be defective or hazardous in accordance with a pre-determined plan promptly and effectively from the market.
2.0 Scope
2.1 Applies to all products that manufactured in NAME Pharmaceuticals Ltd. which required to recall after distribution / marketed.
3.0 Responsibility
3.1 Head of Quality Assurance is responsible
for determining the intensity of recall to be taken by consultation, for analyzing the recalled product and taking
necessary action and also for retaining
final recall report with accompanying documentation for future reference.
3.2 Executive Director is responsible for
taking decision regarding recall and the process through which the product will be recalled,
nominating recall Coordinator and informing about the mode of disposition to the recall coordinator.
3.3 Recall Coordinator is responsible for
handling all aspects of the recall with the appropriate degree of urgency and take all necessary actions in
consultation with the head of Plant and Head of Marketing and
also for preparing a recall report.
3.4 Depot In-charges are responsible for
storage recalled products in secured area until disposal of recalled products and for final
disposal of recalled products and for informing recall progress to coordinator.
4.0 Abbreviations and Definitions
4.1 Product Recall: Product Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Regulatory Authority. Product Recall may be undertaken voluntarily and at any time by manufactures and distributors or at request of the Regulatory Authority.
4.2 Market Withdrawal: Market Withdrawal means a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject a legal action by Regulatory Authority or which involves no violation.
4.3 Stock Recovery: Stock Recovery means 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 sales or use.
4.4 Recall Classification: Recall Classification means the numerical designation i.e. I, II or III assigned by the Regulatory Authority to a particular product recall to indicate the relative degree of hazard presented by the product being recalled.
(a) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
(b) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
(c) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
4.5 ADR: Adverse Drug Reaction
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None
7.0 Procedure
7.1 Product
Recall Investigation Flow Chart:
7.2 Product Recall Procedure
7.2.1 A marketed batch including physician samples, samples for clinical tests/ trials, when does not meet the regulatory requirement/specifications the same should be recalled promptly at least up to the level of Hospital/Retailers.
7.2.2 The parameters which would need the recall of any product would include;
·
Product
mix-ups and label mix-ups.
·
Physical
and visual deterioration like significant discoloration, sedimentation, black
spot on tablets, lump formation and caking inside bottle, precipitation and
crystallization in liquids.
·
Failure
to meet regulatory specification (such as, assay, impurity, dissolution etc.)
·
Adverse
reaction(s) due to product defect.
·
Contamination
with foreign matter (e.g. Glass pieces, metal pieces, black particles,
particulate matter, microbial growth etc.)
·
A
directive from any regulatory authorities to recall a product.
7.2.3 The nature of a problem may become apparent from many sources: Alerting to the possible necessity of 'Freezing' stocks and/ or Recall may arise from:
·
Receipt
of a complaint or other information from a customer
· Receipt of a report from the Regulatory Authorities
· Results obtained by Quality Control Laboratory
· Report from a Production unit
7.2.3.1 The person receiving or initiating the above will immediately inform Head of Quality Assurance giving all details.
7.2.3.2 In case of customer complaint the complaint should be handled according to SOP for Complaints Handling Relevant information to be evaluated includes the following:
· Nature of adverse drug reactions or product related technical complaint.
· Specific product information associated with the complaint such as strength, batch number, unusual storage conditions and conditions of product use.
· Analytical information about the product returned from the complaint and/or retained samples from the same batch.
·
Document
analysis from Production (BPR), Quality Control, and prior complaint records.
7.2.3.3 The purpose of the evaluation is to determine the document whether there is a safety or quality problem, which make the product unsuitable for its intended use.
7.2.3.4 Depending on the depth of the situation the Head of Quality Assurance will immediately consult with Director Technical and upon agreement on the following courses action shall be taken.
· No action should remain pending for further information.
· Freezing of stocks.
· Convening the Recall Committee and notifying their decision to the Marketing Department.
7.2.4 Freezing Stocks
7.2.4.1 Head of Quality Assurance will inform the Distribution Manager to notify all PIL Stores/ Depots by using the fastest mode of communication (telephone, fax, e-mail etc.) where possible, that all stocks of the specified batch(s) of a product shall be 'frozen' with immediate effect.
7.2.4.2 Distribution Manager will notify the above in writing to all personnel of Store/Depots including those which received notification over telephone fax or e-mail as early as possible.
7.2.4.3 On receiving the notification either telephonic or written the Stores/Depots will take appropriate action to ensure that the material is not used (sold).
7.2.4.4 Action subsequent to Freezing:
No movement of 'Frozen' stocks or any
part thereof will take place except under the direction of Head of Quality
Assurance who will notify the action required.
7.2.4.5 Removal of 'Freezing' restrictions can only be authorized by Head of Quality Assurance and must be in writing to Distribution Manager, who in turn will notify all recipients of the original notification.
7.2.5 Recall Panel
Recall Panel consists of:
· Head of Marketing
· Head of Plant
·
Head of
Quality Assurance
7.2.6 A Classification of problem will be determined for stock recovery or recall and the depth of recall by the recall panel.
7.2.7 Stock Recovery
7.2.7.1 When a consensus has been arrived by
the recall panel that the problem has been identified as a stock recovery the
following procedure will be followed:
7.2.7.2 All stock of the recalled product in-house will be placed in the Quarantine area.
7.2.7.3 The recall panel will decide what corrective actions will be taken with the Quarantine merchandise (reprocess, destruction etc.).
7.2.7.4 Head of Quality Assurance will inform
Distribution Manager in writing to return the stock to the Factory.
7.2.8 Market Withdrawal
7.2.8.1 When the recall panel has defined and classified the problem as a market withdrawal, the following procedure will be followed:
7.2.8. 2 The product name, batch number and shipment dates will be compiled by the Quality Assurance Department.
7.2.8.3 The above information will be given to the Marketing Department to immediately generate a list of all customers receiving that batch number.
7.2.8.4 All stocks in-house will be placed under Quarantine.
7.2.8.5 The Marketing Department will carry out the job of withdrawal of product from the market by Medical Representative.
7.2.8.6 The Recall Panel will decide final disposition of the product concerned (reprocess, destruction etc.).
7.2.9 Recall
7.2.9.1 When the decision has been made by the Recall Panel that the problem requires a Recall, the following procedure should be followed:
7.2.9.1.1 A designee of the SPL management will contact the Drugs Administration (DA) for assistance in verifying the class of recall and to coordinate actions with DA.
7.2.9.1.2 The Drug Administration will be supplied with following information:
· Identity of the product involved.
· The product deficiency or possible deficiency on investigation to be identified and reason for removal or correction and the date and circumstances under which the problems occurred.
· Evaluation of the risk associated with the possible deficiency.
· Estimation of total amount of such product in distribution channel.
· Distribution information including the number of direct accounts, and if necessary the identity of the direct accounts.
· A copy of Company's recall communication procedure should be issued or instruction regarding what to do with the proposal. The Marketing Manager, Distribution Manager and Head of Quality Assurance will expedite and communicate the Recall program.
· Proposed strategy for conducting the recall.
·
Name and
telephone number of the Official who should be contacted concerning the recall.
7.2.9.2 In case of recall class I, every potential consumer should be prevented to use the recalled product, so outside aid may be activated immediately and coordinated by the Distribution/ Marketing Manager and Head of Quality Assurance.
7.2.9.3 The general public warning can go through either specialized news media, like professional or trade publications or even through the general news media as deemed appropriate.
7.2.9.4 Head of Quality Assurance should further follow up with Distribution Manager by sending detailed information about the quantity dispatched from the factory and break-up of quantities if distributed to more than Depot/Distributor/Stockiest/Wholesalers/Agent etc. with their contact address, telephone numbers, Fax numbers (inside and outside working hours) e-mail address etc. This information may be obtained from the distribution records maintained at factory.
7.2.9.5 Distribution Manager should further collect the details on quantity, contact address, telephone numbers, fax numbers (inside and outside working hours) e-mail address etc. of the retailers and/ or hospitals from the distribution records available with Depots/Distributors/Wholesalers.
7.2.9.6 Distribution Manager should arrange to collect all unused stock of the subjected product batch(s) right from the Retailer/Hospital to the Depot/Distributor/Wholesalers/ Agent etc. and ship the same to factory as recalled batch(s).
7.2.9.7 Distribution Manager should appraise the Quality Assurance Manager on the progress of the recall from time to time and both of them will monitor the effectiveness of the recall procedure.
7.2.9.8 The Drug Administration has to be kept informed of the results on a periodic basis, until the recall is
completed.
7.2.9.9 Head of Quality Assurance shall also check and update reconciliation of recalled stock on weekly basis. On completion final report including reconciliation between the dispatched and recovered quantities of the product should be prepared and issued to the concerned Regulatory Authorities, Chief Operating Officer and Director Industrial Operations.
7.2.9.10 The recalled batch/product should be quarantined separately as “Recalled Batch/ Product” in the returned goods area and access to the recalled material should be restricted until fate of the material is decided.
7.2.9.11 The Head of Quality Assurance should initiate investigations for the reason(s) of product failure. Failure Investigation should be completed within 30 working days of recall and a corrective action plan should be finalized and implemented to avoid similar instances of failure.
Note : The recall
should be completed within 30 working days.
8.0 Reference Document
8.1 WHO GMP Guideline trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1 Annexure-I : PRODUCT RECALL APPROVAL FORM
9.2 Annexure-II : PRODUCT RECALL FORM
9.3 Annexure-III : Format for “PRODUCT RECALL LOG BOOK”
9.4 Annexure-IV : SUMMARY REPORT OF RECALL
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
|
|
| |||
|
|
11.0 Training
11.1 Head of Quality
Assurance or his nominee give the training of all Officer and Manager of all
Department.
Annexure-I : PRODUCT
RECALL APPROVAL FORM
To: The Honorable Executive Director/ Managing Director
Please kindly approve the recall from the market & depot/discontinue the distribution & sales of the following batch(s) of the product to the market:
Details of the product:
|
Product
Name |
|
Batch
No. |
|
|
Pack
Size |
|
Mfg.
Date |
|
|
Batch
Size |
|
Exp.
Date |
|
Type of Recall: Directive from Drug Authority/ Voluntary
Reason of Recall (Nature of defective):
|
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|
Initiated
By |
Agreed
By |
|
---------------------------------------- (Head of QA) |
---------------------------------------- (Head
of Plant) |
Decision:
|
Š Approved / Š Not Approved
Remarks--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- -------------------------- Signature & Date (Executive Director) |
Information forwarded to: Distribution / Sales/ Marketing / Manufacturing / Product Development
Annexure-II : PRODUCT RECALL FORM
|
Product Recall No. |
|
||||||
|
Initiated By |
-------------------------------- (Head of QA) |
Date |
|
||||
|
Production Name |
|
Pack Size |
|
Product Category |
|
||
|
Batch Quantity |
|
Batch No. |
|
||||
|
Name of Depot with Address |
|
||||||
|
Reason of Recall
|
|
||||||
|
Qty. Received by Depot |
|
Challan No. & Date |
|
||||
|
Recall Details |
Address of the customer (with Market Name) |
Quantity Withdrawn (If any) |
|||||
|
1. |
|
||||||
|
2. |
|
||||||
|
3. |
|
||||||
|
Total Quantities withdraw from Medicine Shop/ Clinic/Hospital etc. |
|
||||||
|
Unsold stock in Depot including complaint
& Damaged Qty. |
|
||||||
|
Total
Return Quantity |
|
||||||
|
Recorded by |
Verified by |
Approved by |
|||||
|
------------------------------ Store In-Charge (Name, Signature & Date) |
------------------------------ Area Manager (Name,
Signature & Date) |
---------------------------------- Regional Sales Manager (Name,
Signature & Date) |
|||||
|
Remarks
(If any):
----------------------------------- Regional Sales
Manager
(Name, Signature & Date) |
|||||||
Annexure-III : Format for “PRODUCT RECALL LOG BOOK”
|
Date |
Recall Number |
Product Name |
Batch No. |
Recall Notification Issued by
& Date |
Recall Qty. |
Recall Closing Date |
Remarks |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page .… of ….
Annexure-IV : Format for “SUMMARY REPORT OF RECALL”
|
Recall
Number |
|
Date
of Recall |
|
|
Name
of Product |
|
Mfg.
Date |
|
|
Strength |
|
Exp.
Date |
|
|
Batch
No. |
|
Pack
Size |
|
|
Batch
Quantity |
|
Date
of summary report |
|
Reason of Recall (Nature of defective):
|
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Summary Report:
|
Name of Depot |
Received quantity by Depot form
Central Warehouse |
Number of pack sold
|
Frozen Stock in Depot (Including
complaint & Damaged stock) |
Number of packs return from
Medicine shop/Clinic/Hospital |
Return Quantity |
Date of return |
Stock in Central Warehouse |
|
A |
B |
C = (A-B) |
D |
E=(C+D) |
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
Total unsold quantity (E+F) |
|
||||||
|
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Action
taken to prevent recurrence:
|
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|
Reported by/Date |
Agreed by/Date |
|
-------------------------------------- Head of Quality Assurance |
--------------------------------- Plant Manager |
Circular to:
The Honorable Managing Director
The Honorable
Executive Director
AGM
(Operation)
Head of
Finance & Accounts
Head of IT
