Product Recall.pdf

TRAINING ON
Product Recall
SOP: SOP/QA/009
Presented by: MD. ZAKARIA FARUKI
Manager & Head of QA
Silva Pharmaceuticals Limited
Date of Training July 20, 2022 1 of 23
SPL

What is Product Recall?
A product recall is a request to return a marketed
product for the reasons relating to deficiencies
in quality, safety or efficacy, including labeling
considered to be violation of the laws
administered by the Regulatory Authority.
** Recall & Principles as per WHO- TRS 986, annex2 (Attachment)
2 of 23
Trainer: Md. Zakaria Faruki, Manager, QA, SPL
SPL

Level of Recall
There are three levels of recall such as -
 Consumer or User Level:
This may vary with product, including any intermediate
wholesale or retail level. Consumer or user may
include individual consumers, patients, physician 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.
3 of 23
SPL

Classification of Recall
Basically there are three types of Recall:
…Ref. US FDA
Class 1
 The defect presents a life threatening or serious
risk to health.
 All class 1 recall shall be executed to the levels of
Wholesale, retail and consumer. In such cases, public
announcements shall be made using print/ electronic
media, e.g: Newspaper, TV, Radio etc.
 Some examples of defects that will result in Class 1
recall are non-sterile injections, contamination with
toxic substances and a label mix-up on a lifesaving
drug.
4 of 23
SPL

Classification of Recall: Cont.….
 Class 2
 The defect may cause mistreatment or a temporary
health problem to the patient, but it is not life
threatening or serious.
 All class 2 recalls shall be executed up to the level of
wholesale and retails (if distribution is known, the
notification should be only sent to the contacts
concerned).
 Products that might cause a temporary health problem,
or pose only a slight threat of a serious nature. Example:
A drug that is under-strength but that is not used to treat
life-threatening situations.
5 of 23
SPL

Classification of Recall: Cont.….
 Class 3
 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.
 If deemed relevant by the issuing authority. All Class 3
recalls shall be executed up to the levels of wholesale.
 Some examples of defects that will result in Class III
recall include products with minor labeling errors or
products which fail to meet product specification or
pharmacopoeia standards but are likely to cause
minimal hazard to users.
6 of 23
SPL

 Reports of adverse reaction/counterfeit drugs.
 Non-conforming result of on-going stability
study.
 Formulation problem/ Mix-ups/ contamination.
 Labeling (packaging) errors.
 Any other reasons having potential impact on
customers/company reputation.
REASON OF RECALL
7 of 23
SPL

Product Recall Practice
at Silva Pharmaceuticals
Ltd…
8 of 23
SPL

Receiving Recall
9 of 23
SPL

Recall forward
Concerned personnel will report the
observations and findings leading to
action of recall to Head of Marketing.
Head of Marketing will inform to Head of
Plant and then to Head of QA.
10 of 23
SPL

RECALL NUMBERING
Product Recall Numbering shall be as following :
QA/RC/001/21
Where
 ‘QA’ Department Name
 ‘RC’ Product recall
 ‘001’ represents for serial number of the
Product Recall, which starts from 001 for the
calendar year.
 ‘21’ represents the last two digits of the year
2021
11 of 23
SPL

RECALL ENTRY
 Record the Product recall numbering details
in Product recall logbook (Appendix-III)
12 of 23
SPL

DESCRIPTION & PROCEDURE…
 Head of QA shall advise to carry out
proper investigation for confirmation of
reported defects either jointly or
independently by QC, R&D, Production &
QA. Marketing personnel can also
participate in investigation.
13 of 23
SPL

PROCEDURE CONT……
 After confirmation and justification of
reported defects, Head of QA shall discuss
with Head of Plant and Head of Marketing.
 Once it is agreed to recall the product(s),
Head of QA shall seek permission for recall
from Executive Director as per (Appendix-I)
14 of 23
SPL

Head of QA shall furnish the batch details for
recall notification in specific format
(Appendix-II). This shall be then forwarded to
Head of Marketing and Head of Sales. Head
of QA shall also communicate with Head of
Sales, Head of Distribution and Head of Ware
House to ensure if there any partial quantity of
product remains.
15 of 23
SPL

The Head of Marketing through Distribution
shall send a product recall circular,
immediately upon receiving the product
recall decision, to all concerned persons
requesting them to return all stock of the
batch under question to the depots.
16 of 23
SPL

 Head of Marketing along with Distribution shall
immediately arrange to freeze all stocks of the
batch lying with distributors, agents and
customers. These all freeze stocks shall be
returned to nearest depots.
 Sales / Distribution Department will record the
receipt, origin & quantity of any recalled product
received & holds the recalled product in a
secure place to avoid mix up with other
materials and send to CWH (Central
Warehouse) with special care.
17 of 23
SPL

 The progress of each recall should be
reviewed by recall coordinator (Head of
QA) at regular, frequent intervals to
monitor its effectiveness and ultimately to
decide that the recall is complete.
18 of 23
SPL

Completion will normally be reached when:
 All the acknowledgement forms (reply of recall
circular) issued are returned.
 The products listed in the acknowledgement
form have been returned.
 There have been no further returns or further
adverse reports concerning the product for a
period of 2 weeks.
 At this point the recall may be terminated.
19 of 23
SPL

 Complete reconciliation of stock of the batch
manufactured / distributed and subsequent
quantity of stock received back. In case of
Regulatory Recall intimated this to Regulatory
Authorities.
 When the recalled product received back from
market to CWH (Central Warehouse) shall be
identified and stored separately in a secured
area while awaiting a decision on its disposal.
20 of 23
SPL

MOCK RECALL PROCEDURE
 Carry out a mock recall for at least one batch per year
of any product, dispatched for sale where maximum
distributors are involved to test the effectiveness of the
arrangements of recall.
 Select one product of one batch and inform to all
concerned both plant & marketing department (PMD,
Sales, distribution etc.) by Head of QA via mail.
 Head of QA or his nominee will collect all information
from concerned department and prepare a summary
report of mock recall according to Appendix-IV.
21 of 23
SPL

22 of 23
SPL

23 of 23
SPL

Product Recall.pdf

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Similar a Product Recall.pdf

Similar a Product Recall.pdf (20)

Más de Md. Zakaria Faruki

Más de Md. Zakaria Faruki (19)

Último

Último (20)

Product Recall.pdf