1.

Purpose:
To establish a procedure for recall of finished product from market. This SOP aims to explain
and standardize the procedure for classification and communications involved in a product
recall, to effectively remove therapeutic goods / products from the market that violate
requirements and that may cause a health hazard to the consumer/user.
2. Scope:
This SOP shall be implemented as such for Marketed Drug Product Recall, Mock Recall at the
Citi pharma Ltd.

3. Responsibilities:
Quality Assurance Department (QA) shall be responsible for:
Investigation for product failure after release.
Initiation of Product Recall.
Initiation of Mock Recall.
Maintaining the Documents and LOG for recall and Mock recall.
Review & Approval of product/Mock recall.
Reporting Investigation findings to Management.
Taking necessary actions to ensure speedy, effective and efficient product recall and
mock recall.
Intimation to Management, Marketing Head, Distribution Head and Warehouse Head
for recall and Mock recall.
The decision for impacted/recalled quantity Intimation to Regulatory authorities.

3.1 Management is responsible for:

Authorization of product recall
Providing necessary support to ensure speedy, effective and efficient recall and Mock
recall.

3.2 Distribution Head shall be responsible for:

Maintaining the records of distribution.
Informing branch managers about the product recall.
Taking necessary actions to ensure speedy, effective and efficient recall and Mock
recall.
Support and Coordination for recall and Mock recall.

3.3 Production Manager shall be responsible for:

Coordination and support in the Investigation.
Checking of Batch records etc.
Taking necessary corrective actions and preventive actions (If required).

3.4 Warehouse officer shall be responsible for:

Providing distribution details of related batch/product.
Reconciliation and proper handling/storage of recalled products.
Destruction of the recalled product
4. Health & Safety:
4.1 All implemented EHS rules and protocols will be strictly followed in compliance of
this procedure.
4.2 EHS aspects must also be considered where applicable.
4.3 Do not print the useless and unnecessary information.
4.4 Product safety and purity must be focused and all the legal obligations must be
followed.
4.5 Handling of materials will be done as per existing procedures.
5. Procedure:
5.1 Recall:
Recall (voluntary/statutory) is an effective method of removing or correcting therapeutic
goods, initiated either by the manufacturer as a result of abnormal observation in any
product quality during periodic review (Internal / External) or investigation of a market
complaint or any other failure or that present a risk of injury or is otherwise defective.
Recall (voluntary/statutory) is an effective method of removing or correcting therapeutic
goods, initiated either by the manufacturer as a result of abnormal observation in any
product quality during periodic review (Internal / External) or investigation of a market
complaint or any other failure or that present a risk of injury or is otherwise defective OR
directed by the Drug Regulatory Authority of Pakistan (DRAP) after notifying that the
product is considered to be in violation of the laws, the DRAP Act, 2012, the Drugs Act,
1976 and the rules framed thereunder. The manufacturer holds the primary responsibility to
carry out complete/total recall whether voluntary or statutory. Recall takes place because
manufacturers, wholesalers and retailers carry out their responsibility to protect the public
health and well-being from the products that represent a risk of health hazard, injury or are
otherwise defective.

5.1.1 Reason for Recall

5.1.1.1 Any complaint from market regarding quality & which after evaluation by
Q.C found to be justified.
5.1.1.2 Any observation from within the organization regarding quality & which
after evaluation by Q.C. is found to be justified.
5.1.1.3 Any written communication received from a complainant (Distributor /
Retailer /Stockiest / Field Staff /Customer / Doctor) regarding the
defects in the product quality (purity, efficacy or any adverse drug
reaction) including its physical characteristic(s), packaging, labeling, etc.
shall be investigated as per the “SOP on Handling of Market
Complaints”.
5.1.1.4 Based on the recommendations given in the Market Complaint
Investigation report, Director Quality Compliance shall initiate the recall
of the product if required. In case, it is found that other batches of the
same product or even of other product(s) have the same defect, the
time frame for investigation may increase.
5.1.2 Recall Classification:
Recall classification is a numerical designation, I, II, or III, that is assigned to a particular
recall. This classification indicates the relative degree of health hazard presented by the
product being recalled and determined by regulatory authority.
Class I:
Class I Recall is a situation in which there is a reasonable probability that the
use of, or exposure to, a violative / defective product will cause serious or
permanent adverse health consequences or death.
Examples of such situations are:
• Wrong product (label and contents are different products)
• Correct product but wrong strength, with serious medical consequences.
• Microbial contamination of sterile injectable or ophthalmic product.
• Chemical contamination with serious medical consequences.
• Mix up of products (‘rogues ‘) within a pack. For example, two different blister
strips within one outer carton, or, two different tablets within the one blister strip.
• Wrong active ingredient in a multi-component product with serious medical
consequences.
• Serious adverse reactions which are batch or product related.
• Any other situation as the Competent Authority or the Board may consider
Class II:
Class II Recall is a situation in which use of, or exposure to, a violative /
defective product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
Examples of such situations are:
• Mislabeling - wrong or missing text or figures.
• Missing or incorrect information - leaflets or inserts.
• Microbial contamination of non-injectable, non-ophthalmic sterile product with
medical consequences.
• Chemical/physical contamination (significant impurities, cross-contamination,
particulates).
• Mix up of products. For example, a case of product A contains one or more
packs of product B.
• Non-compliance with specification (e.g. assay, dissolution, stability, content
uniformity, fill/weight).
 • Insecure closure with serious medical consequences (e.g. cytotoxic, child-
resistant containers, potent product.
• Any other situation as the Competent Authority or the Board may consider.
Class III:
Class III Recall is a situation in which use of, or exposure to, a violative product
is not likely to cause adverse health consequence.
Examples of such situations are:
• Faulty packaging – for example, wrong or missing batch number or expiry
date.
• Faulty closure.
• Packing contamination, for example, microbial spoilage, dirt or detritus,
particulate matter.
• Any other situation as the Competent Authority or the Board may
consider
5.2 Levels of Recall / Depth 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: which 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.
• Distributor/Wholesale Level: all distribution/wholesale levels between the
manufacturer and retailer.
5.3 Product recall type:
Recall of product shall be classified into the following three types:
• Statuary recall.
• Voluntary recall.
• Mock recall.
• Statuary Recall of Product:
A recall directed by Drug control authority / Regulator or any other equivalent
authority, after notifying that the product is considered to be a violation of laws
e.g.:
 • Declared as not of standard quality by Government analyst or qualified person
in case of export.
5.4 Voluntary Recall of Product:
A recall initiated by the company as a result of abnormal observation in any
product quality;
Trigger the Voluntary recall by an incident that affects the Strength, Identity,
Safety, Purity, and Quality of drug product/batch in question such as;
• During the periodic review of the product.
• The batch or batches found not complying with the regulatory specifications
during the post marketing stability study.
• If the batch is found defective during the investigation of the market complaint.
• During any failure investigation, if it is observed that the failure under
investigation might have an adverse quality impact on the already
released batch (e.g. possibility of contamination, mix-up, degradation,
etc.).
• If any unusual observation is noted during a visual inspection of retention
sample which indicates an impact on the quality of the product after
investigation.
• It the post-marketing surveillance reports/pharmacovigilance reports indicate
that there is serious safety risk associated with the product.

5.5 Mock Recall:

• A recall carried out to check the effectiveness of the recall.
• Mock recall shall be carried out at least for one product, dispatched for sale
where maximum distributors are involved
• Mock recall shall be performed for the longest distribution chain at least once
a year.
• During mock recall, Perform the traceability for at least, one of the raw
materials used in the batches identified for mock recall.
• The depth of mock recall shall be up to the stockiest level only.
• Mock recall shall be aimed at the following objective:
• Alert recall team
• Performing the reconciliation to test product traceability.
• Test the responsiveness and knowledge of the team operating
the recall system
• To implement any corrective action to improve the recall
system.
 • Mock Recall process shall be completed within 30 working days
from the date of initiation.
• If an actual recall happen in the year then mock recall will not
take place.

5.6 Time Lines for Effective Recall System & Rapid Alert:
Based on the category of risks involved, a time line of within 24 hours up to a maximum
of 72 hours of initiation for Class I recall. For Class II recall up to a maximum of 10 days
of initiation and for Class III recall up to a maximum of 30 days of initiation is allowed.
Sale/supply/distribution of defective product shall immediately be restricted as the
defect is notified.

This time line is for initiation of recall procedure to commence from the receipt of
information as notified by the Drug Regulatory Authority of Pakistan (DRAP) under
statutory recall or voluntary recall by the manufacturer on its own.

For Quality Defects imposing serious health hazards, the recall has to be initiated
immediately without waiting for a notification from Authority. The time line for
stopping sale/distribution of defective product under Class I shall be ensured within 24
hours and the physical recall being completed within 72 hours. The Class II and Class III
recalls shall be ensured within10 and 30 days, respectively.

Class of Initiation Time Time to ensure Physical

Recall Recall
from initiation
I <24 hours Max 72 hours
II < 24 – max 72 Max 10 days
hours
III < 24 – max 72 Max 30 days
hours

5.7 Initiation for recall:

Distribution/Marketing department receives the complaint from market, document its
detail (Date, Name of Complainer, address, nature of complaint, frequency of
complaint, Product Name, Strength, Batch No, Mfg. date & Exp. Date, any other
necessary Information) in product Complaint form or Inter Office Memo & send it to
Manger Quality Assurance along with the sample of the product. Manager Quality
Assurance will hand over the sample to QA along with the complaint form or Inter
Office Memo. QA will send the sample to the Q.C. Manager for analysis
 Manager Quality Assurance will inform Distribution / Marketing Department about the
nature of problem, product Name, Strength, Batch No., Mfg. Date & Exp. Date, any
other necessary information by email or Inter Office Memo.
Based on the investigation finding & reports, once decided that the product needs to
be recalled, the Technical staff of QA shall initiate the recall as per the Annexure 1 –
Product Recall Initiation Form and LOG shall be maintained.
The technical staff of QA shall allot the recall initiation No. as per below procedure:
Each product recall shall be allocated a recall no, comprises 12 (Twelve)
alphanumeric characters as:
XX/AA/YY/ZZZ
Where;
XX Stands for location code (manufacturing plant)
/: Slash
AA: Stands for (“PR” Product Recall and “MR” for Mock Recall)
/: Slash
YY: Last two digit of the current year
/: Slash
ZZZ: Serial number i.e. 001, 002 ………. n.
• Recall initiation form shall be sent to the Manager Production, and Management
for review. After review from the management, the recall initiation form shall be
approved by Manager Quality Assurance.
• After the approval Manager Quality Assurance shall forward the same to Head
of Distribution and Marketing Head along with distribution details for initiation of
Recall and parallel to management for their information /acknowledgment.
• Manager Quality Assurance shall inform respectively regulatory authorities for
the product recall.
• Manager Quality Assurance shall also publish a public awareness recall notice
in at least three of the daily newspapers having nationwide coverage within 24-
72 hours after decision made on recall for voluntary recall or issuance of recall
directions from DRAP for statutory recall warehouse head shall provide the
distribution details of the product/batch to QA.
• The technical staff of QA shall check the distribution record to identify the
warehouse to which the subject product/batch numbers have been sent.
• Head of Distribution/designee shall plan the implementation of recall and start
the process by ‘‘Recall Notification’ to Warehouses/wholesalers / Physicians /
Pharmacies / retails outlets / Hospitals depending upon the level of the recall.
• The distribution head shall ask stockiest to notify the retailers and advise them to
stop further sale of the product/batch for which recall has been initiated. The
remaining stock shall be sent back to the factory / central warehouse.
• Based on the distribution data, the Distribution Head or his designee
communicates (telephonic communication is immediately confirmed in writing)
the decision to the relevant key points in the distribution chain.
• Considering the severity of the cause of “Recall”, the first message to the
relevant key point in the distribution chain shall be “STOP DISTRIBUTION /
SALE & FREEZE STOCKS”.
• During recall activity of any product site, Manager Quality Assurance shall be
always in contact with distribution head for all correspondence & development.
• Any communication to the regulatory authorities, government authorities, and
institutions during the activity must be shared within the site Quality Assurance
manager, distribution head by telephone, fax or electronic mail.
• The recall process of collecting the stock under question and maintenance of
proper and separate account of such stocks should complete within one (01)
month of initiation of the “Recall”. This time limit may be compressed/ reduced to
the best possible in “Life-threatening” situations.
• In-charge stores (Finished Goods) receives the stock and quarantine it in the
specified quarantine area in its original packing.
• In-charge stores (Finished Goods) verifies the quantities of the product and
informs Q.A. about the receipt.
• If product is not near expiry date, Q.A. shall sample the product and submit
samples to Q.C. for analysis.
• In case product is not identified regarding its Batch number, Mfg. date, identity of
strength (in case if more than one strength registered) it will never be sampled &
will be rejected in straight.
• Q.C. department subjects the product to analysis & may suggest.
• The partial destruction of the quantity.
• The complete destruction of the product.
• Reconciliation of recall product should be done and maintained in log book of
recall product.
5.8 Destruction of Recalled Product:
If Q.C. department after necessary testing activity concludes that no
reprocessing is possible or there can be no identification of the batch # of the
product and destruction is recommended by the Q.C. department, the Manager
Stores raises the ‘destruction note’ clearly indicating the reason for destruction
and quantity thereof and sends this note to Q.A. department.
After proper approval from Q.A. and D.O., Q.A. department receives the stock &
destroys it in the presence of deputed Q.A. person.
Destruction note is duly signed by the Q.A officer, Manager Quality Assurance &
M.D the destruction note is to be filled in the relevant batch file.
 5.9 Follow-up action of Recalled Goods:

The follow-up action consists of a check on the effectiveness of the recall, an

investigation of the reason for the recall, root cause analysis and remedial action
taken to prevent a recurrence of the defect.

Manger Quality Assurance shall monitor the recall process of product/batch to

determine whether the recall is progressing satisfactorily.

The stocks of recalled goods shall be placed under “Quarantine” and stored
separately under lock and key in a secure area until final decision.

5.10 Investigation of recalled product/batch:

• Wherever required, Manager Quality Assurance shall perform the physical
inspection of recalled goods and collect sample from recalled goods for
investigation to establish the root cause of the product quality defect.
• The investigation of the recalled batch(es) shall be conducted to identify the root
cause of the failure and initiate corrective and preventive actions (CAPA).
• Impact assessment shall be conducted on other batches of the concerned
product and further extended to batch(es) of other product(s), wherever
applicable
• If the cause of recall is established to be quality issue associated with any of the
raw material used, then the traceability of that material shall be established in all
the product/batches.
• Based on conclusion of the investigation findings, the Manager Quality
Assurance shall forward investigation report along with corrective and
preventive action and appropriate disposition plan of the batch(es) of recalled
goods as per destruction/disposition SOP Disposition/destruction shall be
done in the presence of Quality Assurance inspector.

5.11 Evaluation of Product Recall:

Check the effectiveness of every recall to verify that the recall notification letter
was received by the customer/distributor, that the customer/distributor read &
understood the letter and followed the recall instructions.
5.12 Closure of Product Recall:
Evaluate the product recall for closure after receiving all possible
customer responses
and the recalled product has been recovered/corrected/redressed/destroyed.
 Record of product recall shall be maintained by QA.

6. GLOSSARY:
SOP = Standard Operating Procedure
Q.A = Quality Assurance
7. RELATED DOCUMENTS: -
7.1 Recall Report QA/NAT/FMT-080
8. REFERENCE:
8.1 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL
INSPECTION CO-OPERATION SCHEME PIC/S PE 009-1 5 (Part I).
8.2 WHO good manufacturing practices for pharmaceutical products: main
principles Annex 2.
8.3 WHO good manufacturing practices for pharmaceutical products: main
principles Annex 3.
8.4 ISO 14001:2015
8.5 ISO 45001:2018
8.6 PICS guideline

9. DOCUMENT HISTORY: -
Obsoleted Updated
Sr. # Reason for Change
Version # Version #
01 N/A 01 NEW DOUCMENTS