ACTIVITY 5

FDA
INSPECTION
CENTRAL PHILIPPINE SECTION 1 | GROUP 2
UNIVERSITY
SCENARI
O
FDA Auditors inspected your drug facility AS PART OF A POST-LICENSING INSPECTION AND
NOTED THREE (3) DEFICIENCIES CONSISTING OF ONE (1) CRITICAL AND TWO (2) MAJOR
DEFICIENCIES, AS FOLLOWS:

1. MOLDS WERE SEEN GROWING ON THE FLOOR OF STERILE AREA FILLING ROOM B.

2. LARGE CRACKS AND CHIPPING OF FLOORS OBSERVED IN THE NON-STERILE LIQUIDS

COMPOUNDING ROOM C.

3. SAMPLING OF INCOMING RAW MATERIALS IS PERFORMED IN THE DISPENSING ROOM.

DATE OF INSPECTION AND REPORT PREPARATION: JAN 20, 2023

 1. Classify the findings into Critical or Major deficiencies.
INSTRUCTIONS:
2. Identify and tabulate the potential Root Cause/s of the deficiencies to facilitate formulation of
the appropriate Corrective Action Preventive Action (CAPA) plan.

3. To facilitate compliance, prepare a Corrective Action Preventive Action (CAPA) plan by putting
the deficiencies into its correct category by filling up the information into the FDA CAPA Plan
form (See file in folder - QWP-FROO-06 Annex 28 CAPA Plan).

(Note – Generate information needed to fill up the form, for sample purposes only, then fill up into
the CAPA form)

4.Take note of the date of inspection and report preparation and indicate the appropriate
completion or proposed completion date.

5. Submit compliance to facilitate closing of the findings.

BY CLAUDIA ALVES
 Deficiency Description of Deficiency Root Cause/s

Critical Molds were seen growing on the floor Improper cleaning

ANSWERS
of sterile area filling room B.  Increased in ambient
temperatures
Deficient room pressurization

Major Large cracks and chipping of floors Poor construction of foundation

observed in the Non-sterile Liquids Shrinkage
Compounding Room C. 

Major Sampling of incoming raw materials is Inadequate space and

performed in the Dispensing room. unorganized manufacturing area
ANSWERS
ANSWERS
ANSWERS
ANSWERS
 ACTIVITY 6

RISK
MANAGEMENT
CENTRAL PHILIPPINE SECTION 1 | GROUP 2
UNIVERSITY
SCENARI
O
IF THE QUALITY OF EACH PACKAGING MATERIAL USED FOR THE PRODUCT DOES NOT
MEET THE REQUIREMENTS, WHAT WILL BE THE IMPACT TO THE PATIENT BASED ON
MATERIAL CATEGORY? INDICATE ANSWER FOR EACH AS FOLLOWS:

(PACKAGING MATERIALS QUALITY )

The following are the categories of packaging materials used to produce Cetirizine Syrup
(Drops):

PACKAGING MATERIALS
Printed labeling / packaging – label, box
Container-closure / primary packaging – glass bottle, cap
Accessory packaging materials – Measuring cup, medicine dropper
• Printed labeling / packaging – If the printed labeling or packaging material does not
satisfy the requirements, the patient may not know how to take the Cetirizine
syrup, when to take it, its potential side effects, or the route of administration.
Since printed labels and packaging are considered compliance aids, this may
affect or decrease patient compliance if it's not presented appropriately.

2. Container-closure / primary packaging – If the container closure or primary packaging

materials of Cetirizine Syrup did not meet the requirements, the patient may question
the integrity of the product and suspect that the drug product is counterfeit or has
been tampered with, which can alter the properties of the product that could
potentially cause harm to the patient, such as unintended side effects or other health
concerns.
BY CLAUDIA ALVES
3. Accessory packaging materials – If the accessory materials of Cetirizine Syrup did
not meet the requirements, the patient would probably get the wrong amount of
dose of the medicine and it would affect the effectiveness of the active
ingredients..

BY CLAUDIA ALVES
For the next part of the activity, refer to Table 1 with assigned numeric equivalents for Severity, Occurrence
and Detection.

Table 1. Numeric equivalents

Value Severity Occurrence Detection

10 Death or long-term effect eg. More than once per Not detectable by
Carcinogenic, teratogenic, liver batch current methods
damage, etc.

8 Hospitalization (patient not cured) Once per batch Statistical Sampling

BY CLAUDIA ALVES
4 Product complaint (bad taste, bad Once every 6 months All manually inspected
smell, doubtful appearance)

2 Inconvenience; no repeat Once every 1 - 2 years 100% inspection

purchase

1 No effect on product Once every 3 - 10 Obvious or monitored

performance years and alarmed

BY CLAUDIA ALVES
INSTRUCTIONS:
• Assign a numeric value for SEVERITY OF IMPACT and DETECTION for each
packaging material for the product using Table 1 as guide in case failure occurs.

PACKAGING SEVERITY OF IMPACT  DETECTION

MATERIAL

Printed labeling / 8 4
packaging

Container-closure / 10 10
primary packaging 

Accessory packaging 2 2
materials 
BY CLAUDIA ALVES
INSTRUCTIONS:
2. Using Table 2 below, fill up the required equivalent
numeric values under each column and compute for the
RPN to determine the risk-ranking as to what materials
should be monitored more closely during issuance for
production. Relate the Detection method indicated below the
table to assign the numeric equivalent under the Detection
column. Assume the same numeric value assigned for
OCCURRENCE (4 – Once every 6 months) for all raw
materials:
BY CLAUDIA ALVES
 Table 2 - Potential defect – Loss of integrity of packaging material

Material category Severity Occurrence Detection RPN (S x O x D)

Printed labeling / 8   4 - Once every 6 4 128

packaging  months

Container-closure 10 4 - Once every 6 10 400

months

Accessory 2  4 - Once every 6 2 16

packaging materials months

BY CLAUDIA ALVES
Detection Methods:

Identify the method of detection to be used per material and assign a corresponding
numeric equivalent for Detection. The following are the Detection methods to be
used.
(Note: The more complex the method, the higher the numeric equivalent to be
assigned).

• Printed labeling / packaging – Measurement of dimensions, visual inspection

• Container-closure – Leak testing, machine trial, measurement of dimensions
• Accessory packaging materials – Measurement of dimensions, visual inspection

BY CLAUDIA ALVES
QUESTIONS:
• Based on the above tabulation and computation of RPN, what is
the order of priority in terms of ensuring packaging material
integrity?

Priority – ANSWER - Container-closure

Least priority – ANSWER - Accessory packaging materials

BY CLAUDIA ALVES
 2. Does the order of priority have anything to do on the use of the packaging
materials to the product?
QUESTIONS:
YES or NO - YES

3. Explain your answer in Number 2. in terms of impact to the patient.

The priority order is connected to how the packaging materials relate to the
product. Priority is given to packaging materials that come into direct touch
with the product. In that situation, the container should be sealed. Product
contamination can have a major influence on patient safety, particularly since
some types of product contamination are difficult to detect. Microbial
contamination of a product is a risk, especially if a container's closure is easily
removed. As a result of the interaction, it could also result in chemical
contamination.
BY CLAUDIA ALVES
 GROUP NO. / NAME OF INTERNS:

Delos Santos, Faith Nicole

Durimon, Irabelle
Estores, Mary Jane Angel
Falalimpa, April Gay
Farren, Queen D' Great
Favila, Theresa Mae
Fuentes, Karizza Divine
Fuentes, Rubie Anne
Galgo, Quennie Dee
Galono, Allyssa Marie

BY CLAUDIA ALVES
SCHOOL: Central Philippine University