COMPLAINTS AND PRODUCT RECALL

How to Tackle it ?

Quality Assurance Department

Pharmaceutical Quality System

BDR

QA

QC

Pass-P
Pass-S

BMR
BPR

Pharmaceutical Quality System

QA

QC

Pharmaceutical Quality System

CCR
QA

QC

Returned

Recall

CUSTOMER COMPLAINTS
Customer complaints are
the perfect opportunity to
assess what aspects of your
business could improve.
There are always things to
improve. Take customer
feedback into serious
consideration, determining
if this is just an issue with
one customer or with many.

LISTEN AND LEARN

Have A.H.E.A.R.T.
for your customers.

Apologize
Hear

Empathize
Ask
Resolve
Thank

PRINCIPLE
All complaints and other information concerning
potentially defective products must be carefully reviewed
according to written procedures.
In order to provide for all contingencies, a system should
be designed to recall, if necessary, promptly and
effectively products known or suspected to be defective
from the market.

Reference : PIC/S (PE 009-12, Part 1, 1 Oct 2015) Chapter 8 : Complaints and Product recall, Page 41-42)

CUSTOMER COMPLAINTS
1. A person should be designated responsible for handling the
complaints and deciding the measures to be taken together with
sufficient supporting staff to assist him. If this person is not the
authorized person, the latter should be made aware of any complaint,
investigation or recall.

2. There should be written procedures describing the action to be

taken, including the need to consider a recall, in the case of a
complaint concerning a possible product defect.
3. Any complaint concerning a product defect should be recorded with
all the original details and thoroughly investigated. The person
responsible for Quality Control should normally be involved in the
study of such problems.

CUSTOMER COMPLAINTS
4. If a product defect is discovered or suspected in a batch,
consideration should be given to checking other batches in order to
determine whether they are also affected. In particular, other batches
which may contain reworks of the defective batch should be
investigated.
5. All the decisions and measures taken as a result of a complaint
should be recorded and referenced to the corresponding batch
records.
6. Complaints records should be reviewed regularly for any
indication of specific or recurring problems requiring attention and
possibly the recall of marketed products.

CUSTOMER COMPLAINTS
7. Special attention should be given to establishing whether a
complaint was caused because of counterfeiting.

8. The Competent Authorities should be informed if a manufacturer

is considering action following possibly faulty manufacture, product
deterioration, detection of counterfeiting or any other serious quality
problems with a product.

RECALL
1. A person should be designated as responsible for execution and
co-ordination of recalls and should be supported by sufficient staff
to handle all the aspects of the recalls with the appropriate degree of
urgency. This responsible person should normally be independent of
the sales and marketing organization. If this person is not the
authorized person, the latter should be made aware of any recall
operation.
2. There should be established written procedures, regularly
checked and updated when necessary, in order to organize any
recall activity.
3. Recall operations should be capable of being initiated promptly
and at any time.

RECALL
4. All Competent Authorities of all countries to which products may
have been distributed should be informed promptly if products are
intended to be recalled because they are, or are suspected of, being
defective.
5. The distribution records should be readily available to the
person(s) responsible for recalls, and should 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.
6. Recalled products should be identified and stored separately in
a secure area while awaiting a decision on their fate.

RECALL
7. The progress of the recall process should be recorded and a final
report issued, including a reconciliation between the delivered and
recovered quantities of the products.
8. The effectiveness of the arrangements for recalls should be
evaluated regularly.

COMPLAINTS AND PRODUCT RECALL

CCR procedure
Customer complaints
Returned goods

Sale representative
By Phone, Fax, e-mail

Risk assessment

Retained sample
Stability testing
FDA request

Recall procedure
Level of recall
Degree of urgency

Failure investigation and CAPA

Root cause analysis, QC testing (Retained sample)

Follow up :

Auditing / Inspection

Risk assessment
Failure Mode Effects Analysis (FMEA)
Severity (S)

Occurrence (O)

Detection (D)

RPN

Determine how serious each effect is. This is the severity rating,
or S. Severity is usually rated on a scale from 1 to 10, where 1 is
insignificant and 10 is catastrophic.
Determine the occurrence rating, or O. This rating estimates the
probability of failure occurring for that reason during the lifetime of
your scope.

Determine the detection rating, or D. This rating estimates how well

the controls can detect either the cause or its failure mode after they
have happened but before the customer is affected.
Calculate the risk priority number, or RPN, which equals S O D.
Identify recommended actions. As actions are completed, calculate the
new risk priority number.

The decision to recall product from the market depending on risk priority number (RPN) or
severity rating.

Recall Procedure
Class I recall: 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.
- Inform the customer immediately when you get the request to recall.
- Investigate and conclude the report to Thai FDA within 15 days.
Class II recall: 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.
- Inform the customer within 1-2 days when you get the request to recall.
- Investigate and conclude the report to Thai FDA within 15 days.

Class III recall: a situation in which use of or exposure to a violate

product is not likely to cause adverse health consequences.
- Inform the customer within 3-5 days when you get the request to recall.
- Investigate and conclude the report to Thai FDA within 30 days.

Case Study
Eye Wash, Due to microbial contamination.

Lamotrigine Orally Disintegrating Tablet 200 mg, Due to the potential for 100 mg blister
cards being packaged in 200 mg containers.
0.25% Bupivacaine Hydrochloride Injection USP, Due to the presence of particulate matter
within a single vial.

RECALLS FOR ALL FDA-REGULATED PRODUCTS

Recalls for all FDA-regulated products

Failure Investigation
Root cause analysis : ishikawa / fish bone diagram with 5M perspectives.
Factor X

Factor X

Factor X

Milieu
(environment)

Man

Method

Factor X

Root cause

Factor X

Material
Factor X

Factor X

Machine
Factor X

Factor X

The process of understanding the key attributes of a particular failure and identifying
the likely causes of failure.

Corrective and Preventive Action (CAPA)

CAPA is a well-known CGMP regulatory concept that focuses on investigating,
understanding, and correcting discrepancies while attempting to prevent their
recurrence.
Corrective action

Root cause

Problem

Quality improvement

Preventive action
Potential cause

Potential problem

Quality improvement

Pharmaceutical Quality System

Supplier Approval and
Evaluation System

Marketing

Purchasing
Approved Vender List

RM/PM

warehouse

Dispensing
Dispensing
center

Contact Manufacturer and Analysis

R&D

Contact Manufacturer

Technology transfer

Production

Quality Risk Management

Incident Report
Failure Investigation and CAPA
Change Control
GMP Self-inspection
Management Review
Product Quality Review

Sale &

FG

logistics

warehouse

Quality Control + Stability Testing

Investigating Out-of-Spec.
Test Result & Control of
Non-Conformance

GMP
Customer

GSP, GDP

Supporting System
( HR, Engineering, )

Customer complaints
Returned & Recall

Batch release
Permit-to-Operate
Product Registration
Document Control
Validation and Qualification
Calibration/Maintenance

CONCLUSIONS
Every pharmaceutical product has established identity, strength, purity, and
other quality characteristics designed to ensure the required levels of safety
and effectiveness.
Drives continual improvement throughout the product and process lifecycle
to ensure a reliable supply of quality products to our patients.
Quality should be built into the product, and testing alone cannot be relied
on to ensure product quality.

THNAK YOU