Pharmaceutical Product recall is defined as the removal of a product sold by the Company due to design or manufacturing defects that could compromise efficiency and safety.
Product Recall
Product purity or by government order. Withdrawal of a product from the market may begin if the product is suspected to be defective or is found to be defective on the basis of a market power study.
complaints, assessment of the likelihood of danger or as prescribed by the FDA or the Authority the health / regulatory authorities (RAs) of the country where the product is sold.
OBJECTIVE
1.1 The Objective of this SOP is to describe procedure for the product recall, responsibilities, actions its evaluation and to provide guidance on:
1.1.1 Circumstances under which a recall of product(s) is warranted.
1.1.2 How a Product recall process is initiated?
1.1.3 Who should be informed about Product Recall?
1.1.4 Who should be involved in evaluating the information regarding Product recall?
1.1.5 How Product recall material should be handled.
SCOPE
2.1 The scope of this SOP is applicable to Product recall and withdrawal of the product from the market.
RESPONSIBILITIES
3.1 Quality Assurance Manager is responsible to ensure that this SOP is followed in its entirety, reviewed and updated as necessary.
3.2 CEO is responsible for issuance of Product recall notice.
3.3 Distribution manager is responsible to collect the record of recalled product.
3.4 Finished product store supervisor is responsible for keeping the product recall in segregated area and their labeling.
3.5 QA is responsible for the proper handling and disposal of recalled products.
DEFINITIONS & ABBREVIATIONS
4.1 FACTS FINDING COMMITTEE: A multifunctional team , Headed by chief executive officer,Sales director, and consisting of Quality Assurance manager, Quality control Manager, Production Manager, technical operation and any other SME (Subject Matter Expert), with the object of reviewing and assessing product quality issues which are deemed to represent potential product recalls.
4.2 MARKET WITHDRAWL: Removal or correction of a marketed product that involves a minor violation that would not be subjected to legal action by a regulatory agency or which involved no violation.
4.3 RECALL:The removal or correction of a marketed product, that is in violation of applicable laws and / or may pose a potential hazard to public health.
4.4 RECALL CLASSIFICATION: Product recall are generally classified as to their risk related to health and safety and these are.
4.4.1 CLASS1: Situation in which there is a reasonable probability that the use of ,or exposure to, a product will cause a serious adverse health consequences.
4.4.2 CLASS II: Situation in which use of , or exposure to, a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
4.4.3 CLASS III: Situation in which use of , or exposure to , a product is not likely to cause adverse health consequences.
4.4.4 CLASS IV: No hazardous effect on health but does not meet the specifications.
4.5 RECALL EXECUTIVE COMMITTEE: A committee convened by the Chief executive and / or Director sale, Production Manager,Quality Assurance Manager,Quality control Manager, and Regulatory Affairs Manager. The Chief executive Officer may invite ad-hoc representative from any other departments (for example, R&D, Manufacturing, Technical Services, Distribution, Sales, etc.) as may be necessary to develop a recommendations recording product recall.
4.6 RECALL FILE: A physical file , Assembled by the product recall administrator ( Appointed by the recall executive committee) documenting all the activities related with the decision making process to recall or not and containing all documents associated with a product recall, such as meeting minutes ,and correspondence with appropriatesregulatory authorities.
4.7 RECALL STRATEGY: A planed specific course of action, to be taken in conducting a specific recall which address the depth of recall, need for public warning, and extent of effectiveness checks for the product recall.
MATERIALS & EQUIPMENTS
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PROCEDURE
INITIATION OF Product RECALL :
6.1.1 Product Recall might be initiated as a result of reports referred to the company from a variety of sources. The reports may be referred by external source (Wholesalers, Retail and Hospital Pharmacist, Medical practitioners, Patients and Drug Regulatory Authority) or by internal source (Sales department, Quality Assurance, Quality Control Department, Finished goods store, Regulatory Affairs department.)
6.1.2 Product Recall might also be initiated as a result of analysis and testing of samples of the products by the regulatory testing laboratories: and as a result of advice received from other bodies.
6.1.3 Certain information is essential to permit the assessment of the validity of the report of a problem with the product;the potential danger to consumers and the action appropriate to the situation .Copies of the Medicine problem Report (FQA-009) are used to report problems to the QA department.
6.1.4 Serious problems which may lead to recall should be reported immediately to QA Manager.
6.1.5 A medical officer must assess each potential recall to evaluate the potential consumer safety risk.
6.1.6 When the need for recall has been established, Additional information is required so that an appropriate recall strategy may be advised.
6.2 INFORMATION REQUIRED FOR ASSESSMENT OF RECALL:
6.2.1 Prior to notification of a recall situation, QA department gather all the relevant information on problem reported, the product and its distribution, and action proposed.
6.2.2 The information (for example, batch size, distribution chains and quantities distributed) to be readily accessible for use in recall situations.
6.2.3 The type of information required may include:
6.2.3.1 Details of the Problem
6.2.3.1.1 Name, telephone and facsimile, number of the person reporting the problem
6.2.3.1.2 Date of report
6.2.3.1.3 Physical location of problem
6.2.3.1.4 Nature of the problem
6.2.3.1.5 Number of similar reports received
6.2.3.1.6 Results of tests (if necessary) and other investigations on suspect or other samples
6.2.3.1.7 Availability for investigation of suspect sample or other samples
6.2.3.2 Details of the Product
6.2.3.2.1 Product name and description including dosage form, strength, drug registration number
6.2.3.2.2 Pack size or type
6.2.3.2.3 Batch number(s)
6.2.3.2.4 Expiry date (if relevant)
6.2.3.2.5 Manufacturing date
6.2.3.2.6 Date released
6.2.3.2.7 Quantity of the batch, date and amount released Process deviations, if any
6.2.3.2.8 Review the Quality Control Records for the affected product Batches
6.2.3.2.9 Evaluation of retained samples
6.2.3.2.10 Evaluate available stability information for product Batches
6.2.3.2.11 Local distribution
6.2.3.2.12 Overseas distribution of Products Batches involved
6.2.3.2.13 Distribution Manager determine the classes of customer for the affected product Batches distributed e.g. main distributor, and other buying group such as Armed forces, Govt. Institutions, Hospitals and as well as foreign customer.
Recall Notification
6.3.1.1 Once all the above information collected, Quality Assurance Manager convenes a Fact Finding Committee, which has the responsibility for
6.3.1.1.1 Reviewing and assessing all available information associated with the potential recall and ensures that it is adequate and appropriate in scope to support decision-making.
6.3.1.1.2 Determining if a recall situation exists.
6.3.1.1.3 If the Fact Finding Committee determines that a potential for a recall does not exist, a written summary of the facts shall be submitted to the Chief Executive and/or Director Sales.
6.3.1.1.4 If the Fact Finding Committee determines that a potential for a recall exists, decision to recall stock can occur with concurrence from the Chief Executive and/or Director Sales.
6.3.1.2 Where appropriate, the Chief Executive and/or Director Sales, convenes a meeting of the Recall Executive Committee.
6.3.1.3 The Recall Executive Committee meets to consider the information generated by the Fact Finding Committee and to evaluate issues that may lead to the recall of products.
6.3.1.4 The Recall Executive Committee reviews these facts and is charged with recommending appropriate actions.
6.3.1.4.1 If the recommendation is to recall, the Chief Executive and/or Director Sales immediately notifies all the concerned persons.
6.3.1.4.2 The intent to recall must be communicated as required to the appropriate regulatory authority as soon as possible, not later than the required notification period.
Recall Strategy
6.4.1.1 Each recall is a unique exercise. However. in tailoring an appropriate recall strategy, there are a number of factors common to all recalls that need to be considered. These include the
6.4.1.1.1 Nature of the deficiency in the product
6.4.1.1.2 Incidence of complaints
6.4.1.1.3 Consumer safety
6.4.1.1.4 Distribution networks
6.4.1.1.5 Recovery procedures
6.4.1.1.6 Resources for corrective action.
6.4.1.2 In discussing the recall strategy, consider the factors which may affect the duration of the recall action, and a completion date should be agreed.
Recall Classification
6.5.1.1 Recalls are classified according to the following classification system:
6.5.1.1.1 Class I recall occurs when products are potentially life-threatening or could cause a serious risk to health.
Examples of Class I Defects
a) Wrong product (label and contents are different products)
b) Correct product but wrong strength, with serious medical consequences
c) Chemical contamination with serious medical consequences
d) Mix up of some products with more than one container involved e) Wrong active ingredient in a multi-component product with serious medical consequences
6.5.1.2 Class II recalls occur when product defects could cause illness or mistreatment, but are not Class I.
Examples of Class II Defects
a) Mislabeling e.g. wrong or missing text or figures
b) Missing Or incorrect information — leaflets or inserts
c) Microbial contamination of non-sterile product with medical consequences
d) Chemical/physical contamination (significant impurities, cross contamination, particulates)
e) Mix up of products in containers
f) Non-compliance with specification (e.g. assay, stability, fill/weight).
g) Insecure closure with serious medical consequences (e.gcytotoxics, child resistant containers, potent products).
6.5.1.3 Class III recalls occur when product defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Examples of Class III Defects
a) Faulty packaging e.g wrong or missing batch number or expiry date
b) Faulty closure
c) Contamination – microbial spoilage, dirt or detritus, particulate matter.
6.5.1.4 Class I or Class II recalls are considered to be urgent safety-related recalls. A safety related recall is defined as the recall of ‘goods of a kind which will or may cause injury to any person’. Where the recall is safety-related, there is a legal requirement to notify the regulatory bodies.
6.5.1.5 Class III recalls are considered to be routine non safety-related recalls
Note: Each recall is a unique exercise and there may be occasions when the scope of a recall can be narrowed to particular customer groups. For example, in some specific situations, hospital pharmacies might be excluded from a recall applying to retail pharmacies.
Recall Level
6.6.1.1 As with classification, the level (or depth) of a recall is to be determined by consultation with regulatory body.
6.6.1.2 In determining the recall level, the principal factors to be considered arc the significance of the hazard (if any), the channels by which the goods have been distributed, and the level to which distribution has taken place. Again, expert opinion may be necessary to determine the significance of the hazard.
6.6.1.3 In this procedure there are four levels of recall: hospital, retail and consumer. One of these levels will be assigned to each recall.
6.6.1.3.1 Distributor and Wholesale level
Includes:
Main Distributor
Govt. Institutional purchasing authorities etc.
6.6.1.3.2 Hospital level
Includes:
Hospital pharmacists and personnel in other hospital departments And wholesale level.
6.6.1.3.3 Retail level
Includes:
Retail pharmacies, Medical, health care practitioners, other retail outlets, e.g. supermarkets and health rood stores; and wholesale and hospital levels.
6.6.1.3.4 Consumer level
Includes:
Patients and other consumers; and wholesale, hospital and retail levels.
Recall Communications
6.7.1.1 Recall should be communicated through the best available resources to the maximum depth level decided.
6.7.1.2 The recall letters should include a factual statement of the reasons for the recall of the product, together with specific details that will allow the product to be easily identified (See example letter at Annex-C).
6.7.1.3 Medicine Recall Letters, Facsimiles or E-mails
6.7.1.3.1 [Use company letterhead; include date and name and title of signatory.]
6.7.1.3.2 Headings, If Class III: ‘Medicine Recall’ or ‘Recall for Product Correction’ or ‘Hazard Alert’, If Class I or II: ‘Urgent Medicine Recall’, or ‘Urgent Recall for Product Correction’
6.7.1.3.3 Composition of Text
6.7.1.3.4 Name of the product
6.7.1.3.5 Drug Registration number when this appears on the product
6.7.1.3.6 Pack size
6.7.1.3.7 Dosage form
6.7.1.3.8 Batch(es) Number
6.7.1.3.9 Expiry date (when this appears on the product)
6.7.1.3.10 other details necessary to allow absolute identification
6.7.1.3.11 Reason for recall
6.7.1.3.12 Necessity to identify and quarantine the product from further sale or supply
6.7.1.3.13 Method of recovery which will be used
6.7.1.3.14 A request to retain the letter in a prominent position for one month in case stock is in transit (where applicable)
6.7.1.3.15 Contact telephone number and facsimile return numbers (paid).
6.7.1.4 If safety to the public is involved and distribution is limited, the information listed above may be given by telephone and then confirmed by the recall letter.
6.7.1.5 Where recalled stock has been distributed to a limited number of hospitals and the recall letter is not to be sent to all hospitals, the letter is to include the following statement or words to the effect of:
6.7.1.5.1 ‘If any of the recalled stock could have been transferred from your hospital to another, please immediately let that hospital know of the recall.
6.7.1.6 A business reply card or a facsimile reply form (see Annex-A for an example) may be included with the recall letter where considers necessary.
6.7.1.7 Envelopes for Dispatch of Recall Letters
6.7.1.7.1 A distinctive standard envelope is required to ensure that it is easily recognized among the large amount of mail usually received byprofessional people. The envelope is used for all classifications of recalls.
6.7.1.7.2 The envelope has been approved by Post and has the words ‘Urgent -Medicine Recall’ or ‘Urgent – Product Correction’ or ‘Hazard Alert’ arc printed diagonally in bold red type on the lop lea hand corner and are underlined with three red bars (See example envelopes at Annex-B)
6.7.1.8 Paid Advertisements
6.7.1.8.1 If the depth of recall is to consumer or retail level and the consumers or retail outlets cannot be identified, advertisements are to be inserted in the daily print media especially in the regions in which distribution has possibly taken place.
6.7.1.8.2 Description of Paid Advertisements
6.7.1.8.2.1.1 Choice of daily media – select all the available major media. Consideration should also be given to the need to inform ethnic groups.
6.7.1.8.2.1.2 Size – Double column width by 10cm deep is the minimum size for advertisements, which should be enclosed in a diagonally hatched border.
6.7.1.8.2.1.3 Position – Advertisements are placed in one of the first five pages of each of the daily print media chosen.
6.7.1.8.2.1.4 Text – This is submitted to the regulatory body for confirmation before it is sent for publication.
6.7.1.8.2.1.5 Headings- if Class III: ‘Medicine Recall’ or ‘or ‘Recall for Product Correction’, if Class 1 or 11: ‘Urgent Medicine Recall’ or ‘Urgent Recall for Product Correction’.
6.7.1.8.2.1.6 Composition of Text
6.7.1.8.2.1.6.1.1 Name of product
6.7.1.8.2.1.6.1.2 Drug Registration number where this appears on the label of the product
6.7.1.8.2.1.6.1.3 Pack size
6.7.1.8.2.1.6.1.4 Dosage form
6.7.1.8.2.1.6.1.5 Batch(es) number
6.7.1.8.2.1.6.1.6 Expiry date (where this appears on the label of the product)
6.7.1.8.2.1.6.1.7 other details necessary to allow absolute identification
6.7.1.8.2.1.6.1.8 Reason for recall
6.7.1.8.2.1.6.1.9 Method of recovery which will be used
6.7.1.8.2.1.6.1.10 If the hazard to the patient is serious, indications of clinical symptoms and advice to consult a medical practitioner, if desired
6.7.1.8.2.1.6.1.11 Contact telephone number.
6.7.1.9 Media Release
6.7.1.9.1 In the case of Class 1 or 11 consumer level recalls, it may be necessary to issue a media release. The text of the media release must contain sufficient detail to uniquely define the product, together with a clear outline of the problem (without causing unnecessary alarm) and must stale the appropriate response by the consumer.’ A telephone number of the contact person, to allow 24-hour access to further information, should be given.
Implementation Of Recall Procedures
6.8.1.1 Quality Assurance will serve as the intra-company coordinator for recall, and Regulatory Affairs Manager for primary contact with the Drug Regulatory Authority.
6.8.1.2 They will be responsible fbr Preparation and sign communications to be sent (as detailed above) to the customers and field force Ibr purpose of tracing and recovering the affected product Batches.
6.8.1.3 Quarantine the affected product Batches at all company controlled inventory locations
6.8.1.4 Prepare a list of the affected product Batches quantities in inventory and transit.
6.8.1.5 Prepare a written summary of each day’s main recall activities. 6.8.6 Submit periodic recall status report to the appropriate Drug Regulatory Authority office and the CEO
6.8.1.6 Prepare the site for Drug Regulation Authority inspection
6.8.1.7 Distribution Manager will be responsible for Stop distribution of affected Batches in consultation with QA, and arrange for delivery of substitute Merchandise to affected customer
6.8.1.8 QA receive and Quarantine all recovered quantities of affected Batches
Termination And Closure Of Recall
6.9.1.1 When the Quality Assurance / Control determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product, the Quality Assurance will request termination of the recall with the approval of Chief Executive Officer by submitting a written request to appropriate Drug Regulatory Authority office.
6.9.1.2 The request will be accompanied with the most current recall status report and a description of the proposed disposition of the recalled product (reconditioned, or destroyed)
6.9.1.3 Quality Assurance will obtain the concurrence of the CEO as to what disposition will be made of the recovered product Batches and affected product Batches in inventory.
6.9.1.4 Regulatory Affairs Manager will then obtain the approval of the Drug Regulatory Authority on the proposed final disposition, prior to taking any action
6.9.1.5 Quality Assurance will document the method used for destruction of all affected inventory and the individuals witnessing the destruction
6.9.1.6 A recall will be considered terminated when the Drug Regulatory Authority determines that all reasonable efforts have been made to remove or correct the drug product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. At that time, the Drug Regulatory Authority will provide SPL with a written notification of recall termination.
6.9.1.7 Subsequent to receipt of the Drug Regulatory Authority recall termination communication, Quality Assurance Manager will prepare and submit a final report to the Chief Executive of the results of the recall and include therein a review of the steps taken to guard against any recurrence of a similar situation
Follow Up Action
6.10.1.1 The follow-up action consists of a check on the effectiveness of the recall and an investigation of the reason for the recall and remedial action taken to prevent a recurrence of the problem.
6.10.1.2 The QA Manager examines the effectiveness of recall action. Recall records may be inspected by regulatory body.
6.10.1.3 Investigation of the Reasons for Recall and Initiation of Remedial Action
6.10.1.3.1 On completion of a recall, the QA department provides details of the remedial action proposed to prevent a recurrence of the problem which gave rise to the recall. Where the nature of the problem and appropriate remedial action are not apparent, investigation and in some cases Good Manufacturing Practice audits may be necessary.
Record Retention
6.11.1.1 Quality Assurance will maintain the official file of recall record.
6.11.1.2 Such records will be maintained for a period of at least one year past the expiration date of the drug product.
REFERENCES
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REQUIRED DOCUMENT
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9.0 ATTACHED DOCUMENT
9.1 Medicine Problem Report, Form (FQA-009)
9.2 Business Reply Card, Annex-A
9.3 Recall Letter Envelop, Annex-B
9.4 Sample for Recall Letter, Annex-C
9.5 Sample for Media Release, Annex-D
ANNEX-A
| PLEASE FILL OUT AND RETURN:
To:______Pharmaceuticals Attention: Quality Assurance Manager _________________________
Subject: Recall of (Product Name)___________________________________________________________________________ From: Name of Institution, Distributor, Pharmacy _______________________________________________________________ Contact Person: _____________________________________ Contact Number: ________________________________ ________________________________________________________________________________________________________
We do / do not have stock which is subject to this recall. Stock Received: Batch #: __________________________________ Quantity: _____________________ Batch #: __________________________________ Quantity: _____________________
Stock in hand subject to recall: Batch #: __________________________________ Quantity: _____________________ Batch #: __________________________________ Quantity: _____________________
Any other relevant detail: ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________
Name: _________________________ Signature: __________________________________ |
| BUSINESS REPLY MAIL
Permit #———— POSTAGE WILL BE PAID BY __________________Pharmaceuticals |
ANNEX-B
RECALL LETTER ENVELOP
| URGENT MEDICINE RECALL |
| URGENT MEDICINE CORRECTION |
| HAZARD ALERT |
ANNEX-C
SAMPLE FOR RECALL LETTER
Example of a recall letter for a hospital level recall (similar letters, with appropriate amendments, would be required for retail or wholesale level recall letters to physicians)
| < Company letterhead paper>
Chief Executive Officer < Hospital Address> Attention:
Subject: URGENT MEDICINE RECALL
<PRODUCT NAME> Batch Number(s): xxxxxxx Order number: 00000000 __________Pharmaceuticals (Pvt.) Ltd., following advice that the batches said above may not fit for use and is recalling the above batches of <product name>. No other batches or pack sizes of this product are affected by this recall. The batch numbers are displayed on the bottom right hand corner on the front of the packs. Please inspect your stocks and quarantine all units from the above batch numbers, then complete the attached Facsimile Reply Form and fax it to us so that we may arrange for your stock to be recovered and replacement stock, or a credit note, issued. Please complete the Facsimile Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile this process. If any of the recalled stock could have been transferred from your hospital to another, please • immediately let that hospital know of the recall. It would be appreciated if you would then telephone us so that we can make contact with the hospital supplied from your hospital. Please retain this letter in a prominent position for one month in case stock is in transit. _________________Pharmaceuticals (Pvt.) Ltd. sincerely regrets any inconvenience caused to your hospital.
<Signature> Title <Date> |
ANNEX-D
SAMPLE FOR MEDIA RELEASE
| URGENT MEDICAL RECALL
<PRODUCT NAME> 60mL bottle Batch number XXXXX, Expiry date: Dec 2016
______________________Pharmaceuticals (Pvt.) Ltd., following consultation with the regulatory body, is recalling, batch XXXXX of <Product Name> (which is an anti-fungal used to treat xxxxxxxxxxxx,) because (Description of the reason) of this batch. No other batches of <Product name> are affected by this recall.
If you have a bottle of <Product name> from hatch XXXXX, do not use it. Return it to the place of purchase for a refund or call our customer service line to arrange the return of affected product andrefund.
CUSTOMER SERVICE 00000 XXX XXX
Anyone who is concerned in any way about the use of this product should consult their doctor. _______Pharmaceuticals (Pvt.) Ltd. sincerely regrets any inconvenience to their customers. |