SCENARIO:

The Audit Team of a pharmaceutical manufacturing company that produces a high volume of
fast-moving Solid Oral Dosage forms is preparing their audit plans for the coming year. Part of
their plan is the audit of various areas and activities in the plant (internal audit or self-
inspection). Risk management is applied during prioritization of areas to be audited to optimize
the available resources. The following has been identified as the grouping of areas in one Section
to be audited:

1. Bulk Compounding 
2. Primary packaging 
3. Secondary packaging 

If cross-contamination occurs in each of the areas, what will be the impact to the quality of the
product? How do the areas differ in the impact and extent of cross-contamination? Indicate
answer for each as follows: (30 points)

1. Bulk Compounding – Microbiological contamination levels above pharmacopoeial limits

may lead to alterations and spoilage of active ingredients and cause adverse effects by
infections or toxins.
2. Primary packaging –   defects in primary packaging may lead exposure of the drug to
contaminants that may lead to degradation of the drug product, resulting from microbial
proliferation .
3. Secondary packaging – Contamination of in this area would not directly affect the quality
of the drug since it is not in direct contact with the drug itself, but may pose safety issues
on particle build up inside the packaging.

PRIORITIZATION WITHIN THE SAME SECTION

1. Using Table 2, check the numeric equivalents of Severity, Occurrence and Detection.
These values will be used to compute for the RPN to help you decide what area to
prioritize. 

 Table 3. Numeric equivalents

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

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

4 Product complaint (bad taste, bad smell, Once every 6 All manually inspected
doubtful appearance) months
 2 Inconvenience; no repeat purchase Once every 1 - 2 100% inspection
years
1 No effect on product performance Once every 3 - 10 Obvious or monitored
years and alarmed

2. Relate the type of contamination that will occur in the area to the Severity indicated in
Table 2 and the Detection method to the Detection indicated in Table 3 to get the
appropriate numeric equivalent, using your judgement. Assume a numeric equivalent of
2-Once every 1 - 2 years for all areas. 
3. Based on the conditions indicated above, fill up the corresponding numeric values in
Table 3 under the columns for Severity, Occurrence and Detection. Compute for the
RPN by multiplying the values under Severity, Occurrence and Detection. 

Table 3 - Potential defect – Contamination / cross-contamination in Solids area (30 points)

Severity RPN (S x O x
Area (affected products) Occurrence Detection D)
Bulk Compounding (all products in the area) 10 2 10 200
Primary packaging (Tablets and capsules) 8 2 4 64
Secondary packaging (Tablets and capsules) 2 2 2 8

Severity (Type of contamination / problem):

Identify the Contamination problems (equals Severity) per area and assign a corresponding
numeric equivalent for Severity. The following are the Contamination problems in the area. 
(Note: The more complex the method, the higher the numeric equivalent to be assigned). 

4. Bulk Compounding – Chemical, microbial and debris contamination: 10

5. Primary packaging – Microbial and debris contamination: 8
6. Secondary packaging – Mix-up / pilferage: 2

Detection (Contaminant detection method):

Identify the method of detection of contamination per area 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). 

1. Bulk Compounding – HPLC, microbial testing and visual inspection: 10

2. Primary packaging – Microbial testing and visual inspection: 4
3. Secondary packaging –Visual inspection and frisking: 2
QUESTIONS 
Questions:
1. Based on the above tabulation and computation of RPN, what is the order of priority in
terms of areas to be audited? (10 points)
Priority – Bulk Compounding
Least priority – Secondary Packaging

2. Does the order of priority have anything to do with the area to be audited?  (2 points)
YES or NO –  yes

3. Explain your answer in Number 2. in terms of impact to the quality of product. (8 points)
ANSWER – The order of the priority gives the highest attention of area to be audited, in
which in this case, the Bulk compounding area garnered the highest RPN. This area
would highly impact the quality of the product since any cross-contamination would lead
to alterations of the quality and efficacy, the purity of the drug and early spoilage of the
API, thus compromising the safety of our patients and eventually affects the
sustainability of the manufacturing business.

Name of Interns:
Gomogao, Johaimah
Gongob, Beniedick
Hadji Jamel, Rabiha
Hernando, Ylyssa Kaye
Lim, Erwin
Macayan, Gizelle Mae
Maglinte, Lordjay Liza
Manamparan, Hosny
Manamparan, Prince Abdul Salam
Monteron, Fatma Ramla
Ontawar, Arifa
Pumbayabaya, Omekhalthom

School: Adventist Medical Center College