1.0
PURPOSE:
To lay down procedure for prompt and effective recall of
finished products known or suspected to be defective, from market.
2.0
SCOPE:
This SOP is applicable to all the
product recalls, manufactured in the Formulation
plant -----------------------
3.0
RESPONSIBILITY:
3.1
Quality
Assurance : Decision for
recall
: Reviewing status of recall
3.2
Head QA :
Initiation for product recall
: Communication to concerned departments
: Initiation of investigation
: Product Review (current & other manufactured
batches)
: Ensuring batch recalled is quarantined
3.3
Distribution
Department : Provide distribution list
: Facilitating recall from
all distribution points
: Ensuring stoppage of
further sale & distribution of suspected
batches
3.4
Manager
stores : Storage of recalled goods
: Destruction of recalled
goods
4.0
ACCOUNTABILITY:
The Accountability lies upon Quality
Assurance Head for implementation and complies of the SOP.
5.0
PROCEDURE:
5.1
DEFINITION OF RECALL:
5.1.1
Removal from the market of the specified batches of a product/ entire
product.
5.1.2
Any written communication received from complainant (Distributor/
retailer / stockiest / Field staff / customer / doctor) regarding the defects
in product quality (purity, efficacy and any adverse drug reaction) including
its physical characteristics, packaging, labeling etc. shall be investigated as
per “SOP on handling of market complaints”
5.2
A product shall be recalled in
following cases:
5.2.1
When there is market complaint and on investigation it is essential to
recall the product as the product may cause serious adverse effect.
5.2.2
When during Control Sample Observation, it is observed that there is
degradation in product and it may cause serious adverse effect.
5.2.3
In case any problem is observed during stability of any of the product.
5.2.4
In case any critical labeling error or any critical formulation error.
5.2.5
Any notification from Drug Control Authorities regarding the quality of a
product.
5.3
Prior to approving a recall, the top management shall review the need for
a recall with the client company representative. For this purpose a complete
description of the possible recall situation is required including but not
limited to the following:
5.3.1
Name of Product involved and Batch number.
5.3.2
Description of potential problem and how discovered, e.g. product
complaint (including number of complaint), failure in testing or audit.
5.3.3
A summary of the quantities involved, i.e. original quantity, quantity
held, quantity released and quantity distributed.
5.3.4
Report of any action or investigation undertaken at local level.
5.3.5
Copies of any correspondence with local regulatory agencies.
5.3.6
Rationale for proposed recall including proposed method and depth of recall.
5.4
The following procedure outlines actions required for recall:
5.4.1
Any employee who becomes aware of a possible need for a recall will
advise their supervisor, who will notify the management.
5.4.2
The plant manager will instruct the distribution department and
individual stockiest for stopping further distribution of products. The process
will continue till retailer.
5.4.3
The plant manager will either notify the top management in case of a
local government enforced / mandated recall or request approval of the top management
as per the format number F/QA-015-01.
5.4.4
After reviewing the need for a recall the top management and client
company representative will communicate the decision, including specific recall
implementation instructions to the Plant Head. The Plant Head will notify the
appropriate regulatory agencies, if required by local health regulations.
5.5
When a product needs to be recall from market it must be determined what
classification it must receive. Find out the seriousness of health hazards
caused by the product and its consequences. The seriousness shall be classified
as:
Class I- Class I is a situation in which the consequence of use or
exposure to the product are life threatening or involve in a serious adverse
health consequence. This class of defects required recall within 24 hours.
Class II- Class II is a situation in which the use of, or exposure to,
a violation product may cause temporary adverse health consequence or where the
probability of serious adverse health consequence is remote. This class of defects
required recall within 72 hours.
Class III- Class III is a situation in which the use of, or exposure to,
the product is not likely to cause adverse health consequence. This class of
defects required recall within 5 Days.
5.6
The form shall be forwarded to Head-QA and Plant Head for approval.
5.7
The reasons and conditions of the product recall and its class shall be
discussed by Head QA with Plant Head, Regulatory, Marketing and Qualified
Person (QP- wherever applicable). An action plan shall be prepared by this
group.
5.8
If the product batches to be recalled are from the regulated markets,
necessary communication will be sent by Head QA or QP to the respective
Regulatory Authority, after consulting Regulatory Affairs.
5.9
The Product Recall shall be initiated promptly no sooner the decision is
taken by Head QA. Necessary communication shall be sent to all concerned within
the shortest time period, but not later than 72 hours in case of Class I and
Class II.
5.9.1
The Distribution record shall be checked by Head QA in consultation with
Distribution Department to identify the destinations, the quantities,
batch number-wise.
5.9.2
Head – QA shall advise Distribution department
and Marketing department to instruct the distributors and stockiest to stop
further dissemination and sale of the product batches.
5.9.3
The communication can be sent by telephone,
email, fax, and any other faster mode. Where required this may also be put on
news media, but only in case of Class I recall.
A
follow-up on the communication and response to it shall be monitored by QA,
Distribution and Marketing department.
5.9.4
Necessary arrangements shall be administered by the Supply chain to
receive the recalled product batches’ quantities. The returned stock shall be
reconciled to the closest quantity of actual distribution.
5.9.5
This reconciliation shall consider all unit or pack of batches under
recall even from hospital and pharmacy stores. The batch documentation and
reconciliation shall be thoroughly scrutinized by competent personnel from QA,
Distribution and Marketing departments.
5.9.6
In the likelihood of possibility of destruction of stocks in the country
of market, the Head – QA and QP shall delegate responsibility to the supply
chain to do so with the permission of the local Regulatory authority.
5.9.7
The returned/ recalled stocks shall be destroyed as per SOP on Rejection
and destruction policy of drug products and its components.
5.9.8
All records and communications related to Product Recall shall be
properly maintained by the respective departments, such as Distribution department,
Marketing department and QA as per Annexure QAGN016/A02. These records shall be
reviewed by QA for adequacy and accuracy.
5.9.9
The local Drug Control Authority shall also be
informed of such recalls by QA.
5.10
When there is need for recall of any product, it is initiated by QA Head.
Quality Assurance Head shall make the entry in to Product Recall Log Format
No.: F/QA-022-02 and allot it a Product Recall Number e. g. PR/18/001, It
is allotted as PR/XXYYY
Where.....
PR
- Product Recall Number.
XX
- current year like 18 for this year.
YYY
– Serial Number of the Product Recall.
5.11
QA Head shall then fill the Product Recall Form in Format No.: F/QA-022-01.
This includes Product Recall No., Product Name, Batch No., Mfg. Date, Exp.
Date, Market Complaint No. if any, reason for recall and names and addresses of
persons recalled from.
5.12
The distribution records shall be readily available to the QA Head for
recalls, and these records shall contain sufficient information on wholesalers
and directly supplied customers (with addresses, phone and/or fax numbers
inside and outside working hours, batches and amounts delivered), including
those for exported products and medical samples. Send the recall notification
to the party/vendor on company letter head with the following details:
5.12.1
The Product Name, strength, pack size
5.12.2
Batch No.
5.12.3
Reason for Recall
5.12.4
Further action required by them
5.13
The QA Head along with Head marketing & Distribution shall implement
the recall without delay.
5.14
Recall shall be completed with in 45 days of initiation.
5.15
Recalled products shall be identified and stored separately in a secure
area in Finish Goods Store while awaiting a decision on their fate.
5.16
In case if the product belongs to third party or loan license, the QA of respective
party shall decide whether the product shall be destroyed or reprocessed.
5.17
Verify that CAPA system procedure that address the requirement of the
quality system regulation have been
defined and documented.
5.18
Determine if appropriate sources of product and quality problem have been
identified. Confirm that data from these sources are analyzed to identify existing
product and quality problem that may require corrective action.
5.19
Determine if sources of product and quality information that may show
unfavorable trends have been identified. Confirm that data from these sources
are analyzed to identify potential product and quality problem that may require
preventive action.
5.20
Challenge the quality data information system .Verified that the data
received by the CAPA system are complete, accurate and timely.
5.21
If the product has to destroyed it shall be done in the manufacturing
premises & If the product is reprocessed then it shall be kept for
stability.
5.22
The progress of the recall process shall be recorded and a final report
issued, including reconciliation between the delivered and recovered quantities
of the products. The recall close out report will be shared with the regulatory
authorities, third party or loan license party.
5.23
The effectiveness of the arrangements for recalls shall be evaluated from
time to time.
6.0
LIST OF ANNEXURE AND FORMATS:
Sr. No. |
Title of Format |
Format No. |
01 |
Product Recall Approval Form |
F/QA-022-01 |
02 |
Product Recall Form |
F/QA-022-02 |
03 |
Product Recall Log |
F/QA-022-03 |
04 |
Product Recall Process Flow Chart |
A/QA-022-01 |
7.0
REFERENCES:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-014
7.4
SOP-QA-031
7.5
SOP-QA-008
7.6
SOP-QA-035
8.0
REVISION HISTORY:
Sr. No. |
Date |
Reason for Revision |
Revision No |
1.
|
31/10/2018 |
New SOP |
R0 |
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
Sr. No |
Abbreviations |
Details |
1.
|
SOP |
Standard operating procedure |
2.
|
QA |
Quality assurance |
Product Recall No.: (to be
assigned by QA) |
Date: |
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1.1 |
Product
Name: |
Market Complaint No.: |
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1.2 |
Batch
Size: |
Category:
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1.3 |
Batch
No.: |
Mfg.: |
Exp.: |
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1.4 |
Initiated
By: |
Market: |
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1.5 |
Reason
for Recall: |
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1.6 |
Recall
Details: |
Batch number wise Total
Quantities: Pack
sizes: Distribution
record verification: Distribution
destinations: |
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1.7 |
Proposed
Recall Plan: |
Mode
of communications: Information
to Qualified Person and
inputs: Information
to RA and inputs: Information
to Regulatory authority: Returned
Goods Receiving point: Follow-up
results: |
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1.8 |
Attachments
/ Supporting Data (if
any): |
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Initiated by QA |
Name |
Signature |
Date |
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2.0
Review by Qualified Person (comments): |
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Review
by Qualified Person |
Name |
Signature |
Date |
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3.0
Review by Head-QA (comments): |
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Review
by Head-QA |
Name |
Signature |
Date |
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4.0 |
QA Review / Approval |
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5.0 |
Implementation
of Product Recall |
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5.1 |
Dates of Recall communications: - Stoppage of
distribution & sale: - Return of
Goods: |
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5.2 |
Quantities returned and Reconciliation:
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5.3 |
Recall process review done by (names & signatures) QA, Distribution,
Marketing: ……………………………………………………………………………………………………………….., ……………………………………………………………………………………………………………….., ……………………………………………………………………………………………………………….., |
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Review
by Qualified Person (where
applicable) |
Name |
Signature |
Date |
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Review
by Head-Distribution |
Name |
Signature |
Date |
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6.0
Decision Taken: |
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QA Head (Sign/Date): QA Loan License/Third party If Applicable
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Destroyed on / Date: |
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Reprocessing
done / Date:
|
Sr.
No. |
Reprocessing/Destruction Details |
Quantity |
Done
by /on |
Verified
by /on |
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Product kept for stability / Date: CAPA No. (If required) |
7.0 |
QA Review of
Implementation & Closure |
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7.1 |
Summary Report of Recall:
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7.2 |
QA Comments on Reconciliation:
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7.2.1 |
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7.2.2 |
If No, Justification:
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7.2.3 |
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7.2.4 |
If No, Justification:
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7.2.5 |
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7.2.6 |
Remarks (if any):
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Closure
Approved by Head-QA |
Name |
Signature |
Date |
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END OF DOCUMENT
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Pharmaceutical guideline only