III.

Raw Material Potency Adjustment and

Inventory Management in Manufacturing Dispensing

Instructions:
● Read the following background and production scenarios. Answer the highlighted general
questions and cases assigned for each group. Refer to further details below.
● Reflect all values in three decimal places.
● Provide proof of calculations. No calculations, no score.
● The cases provided below are NOT related to each other. Answer the questions for
each case exclusively.
● Apply the concepts of FIFO (first-in, first-out) and FEFO (first-expiry, first-out) and
manage your existing stocks to optimize inventory and minimize material disposal.

BACKGROUND

Some active pharmaceutical ingredients (API) like vitamins degrade over time due to several factors such as repeated
exposure to light, oxygen, and unsuitable temperature and humidity conditions. To ensure 100% potency of these APIs in
the finished products, the dispensing pharmacist performs necessary calculations and quantity adjustments prior to
dispensing of the raw material to the next manufacturing process.

The dispensing pharmacist reviews the formulation to see how much of the API is required – where such quantity
presumes 100% potency. However, since not all APIs have initial 100% potency (due to degradation or other factors), the
pharmacist must verify the actual potencies from the official laboratory results before weighing.

As an example, if the formulation requires 10.000 kg of Vit. B12 which has an assay value of 98.0%, the pharmacist
calculates the new quantity to be weighed using the formula below:
𝑡𝑎𝑟𝑔𝑒𝑡 𝑝𝑜𝑡𝑒𝑛𝑐𝑦
𝑟𝑒𝑞𝑢𝑖𝑟𝑒𝑑 𝑞𝑢𝑎𝑛𝑡𝑖𝑡𝑦 𝑥 𝑎𝑐𝑡𝑢𝑎𝑙 𝑝𝑜𝑡𝑒𝑛𝑐𝑦
= 𝑎𝑑𝑗𝑢𝑠𝑡𝑒𝑑 𝑞𝑢𝑎𝑛𝑡𝑖𝑡𝑦

100.0%
10. 000 𝑘𝑔 𝑥 98.0%
= 10. 204 𝑘𝑔

Since the Vit B12 available has a lower potency of 98.0%, an additional 0.204 kg must be weighed to attain 100%
potency in the finished drug product. Same goes to some cases where the potency of API is greater than 100%, there is
a need to reduce the final quantity to be dispensed to prevent potential high assay issues.

Dear Future Pharmacists,

I made this activity for you to have a glimpse of what I do when I was a dispensing
pharmacist in a manufacturing setting – not to add burden on your end, but to simulate the
nature of my work should you venture a career in the pharmaceutical manufacturing
industry. After all, this internship should be an experience! ☺

Try not to get overwhelmed with the values, numbers, and basic mathematical operations
that you will be dealing throughout this activity. This is designed to assess your
decision-making, analysis, and comprehension which are all essential skillsets in any job
that you would pursue soon.

A series of cases are provided to mirror some realities of my job. These were deliberately
woven for you to assume my position and see the interrelatedness of activities – how a
single error could be costly in the contexts of business and more importantly, patient and
customer’s safety and welfare.

Kindly do your best to answer this activity with integrity.

I expect nothing but academic honesty.

Regards,
Darien
PPG Pharmaceuticals is required to produce 8,000,000 Viplex Tablets for DR Corporation by the end of April 2023.

Viplex (Vitamin B-Complex) is a multivitamin product that contains Vitamin B1 (Thiamine), B2 (Riboflavin), B3 (Niacin), B5 (Pantothenic
Acid), B6 (Pyridoxine), and B12 (Cyanocobalamin) that play vital roles in maintaining overall bodily function. As highlighted in the
formulation below, the final quantities of Vitamins B2, B6, and B12 need further recalculations to attain 100.0% prior dispensing.

FORMULATION OF VIPLEX TABLET

(batch size: 1,000,000 tablets)
Material Code Material Name Quantity
R1000005001 Thiamine Mononitrate, USP 12.500 kg
R1000000002 Riboflavin, USP *15.000 kg
R1000000333 Niacinamide, USP 12.500 kg
R1000002005 Calcium Pantothenate, USP 5.000 kg
R1000001006 Pyridoxine Hydrochloride, USP *4.500 kg
R1000001012 Cyanocobalamin, USP *10.000 kg
R1200816342 Lactose Monohydrate (Spray Dried) 35.000 kg
R3566123110 Starch Regular, NF 20.000 kg
R2200099115 Magnesium Stearate, NF 4.000 kg
*if potency is 100.0%

As the Dispensing Pharmacist of PPG Pharmaceuticals, it is your responsibility to regularly monitor and manage the inventory of all raw
materials present in the Dispensing Area – ensuring that FIFO/FEFO principles are enforced and calculations are accurately performed
to avert product quality issues. After system extraction of all existing material stocks needed to produce Viplex Tablets, you have
managed to obtain the following information:

RIBOFLAVIN, USP
Lot No. Location Supplier Available Quantity Quantity per Expiry Date Potency
(kg) container (kg) (mm/dd/yy) (%)
R100021 Harman Finochem 5.000 10.000 08/18/23 100.0
Dispensing
R100022 Hubei Guangji 20.000 5.000 12/19/23 100.0
R100023 Hubei Guangji 40.000 5.000 02/14/24 100.0
R100024 Harman Finochem 20.000 10.000 06/16/24 99.3
R100025 Warehouse Prachi Pharmaceuticals 30.000 15.000 02/01/24 100.0
R100026 Prachi Pharmaceuticals 30.000 15.000 01/31/25 101.2
R100027 Harman Finochem 30.000 10.000 10/25/25 98.6
PYRIDOXINE HYDROCHLORIDE, USP
Lot No. Location Supplier Available Quantity Quantity per Expiry Date Potency
(kg) container (kg) (mm/dd/yy) (%)
P100018 Dispensing Midwest Pharmaceuticals 4.500 5.000 07/21/23 100.0
P100019 Hubei Guangji 10.000 5.000 01/08/24 100.0
P100020 Fagron Industry 10.000 10.000 10/30/23 95.0
P100021 Warehouse Fagron Industry 30.000 10.000 11/01/23 96.2
P100022 Midwest Pharmaceuticals 40.000 5.000 07/21/23 100.0
P100023 Hubei Guangji 30.000 5.000 12/16/25 102.1
CYANOCOBALAMIN, USP
Lot No. Location Supplier Available Quantity Quantity per Expiry Date Potency
(kg) container (kg) (mm/dd/yy) (%)
C100016 Endo International 1.000 5.000 10/10/23 100.0
C100017 Dispensing Bristol-Meyers Squibb 4.000 10.000 12/01/23 100.0
C100018 Bristol-Meyers Squibb 10.000 10.000 12/21/23 100.0
C100019 Endo International 25.000 5.000 02/24/24 100.0
C100020 Endo International 25.000 5.000 06/16/24 101.5
C100021 Warehouse Sanofi-Aventis 20.000 5.000 03/18/24 96.8
C100022 Sanofi-Aventis 20.000 5.000 09/27/24 98.1
C100023 Bristol-Meyers Squibb 10.000 10.000 12/31/24 100.0
General Questions:

1. Present a brief introduction of the assigned API, including special handling instructions applicable to manufacturing
dispensing.

Riboflavin, USP
o A water-soluble B vitamin, naturally occurring in some foods and is available as food supplement
o Essential component and precursor of two major coenzymes, flavin mononucleotide (FMN; also known as
riboflavin-5’-phosphate) and flavin adenine dinucleotide (FAD)
o It and its derivatives are photo labile therefore can be rapidly inactivated by ultraviolet and visible light
o Incompatible with strong oxidizing agents, bases, reducing agents
o Handled in accordance with good industrial hygiene and safety practice, preserved in tightly closed, light-resistant
containers and kept in a dry, well-ventilated place
o Recommended storage temperature is 2-8 degrees Celsius

2. Calculate the number of Viplex Tablets batches needed to meet the demand of PPG Pharmaceuticals.

𝑟𝑒𝑞𝑢𝑖𝑟𝑒𝑑 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑡𝑎𝑏𝑙𝑒𝑡𝑠

= 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒

8 , 000 , 000 . 000 𝑡𝑎𝑏𝑙𝑒𝑡𝑠

= 1 , 000, 000 . 000 𝑡𝑎𝑏𝑙𝑒𝑡𝑠

= 8 batches

3. Calculate the theoretical weight of bulk granules that would be produced (after granulation) assuming 100% potency on all
APIs.

12.500 kg (Thiamine Mononitrate, USP) + 15.000 kg (Riboflavin, USP) + 12.500 kg (Niacinamide, USP) + 5.000 kg (Calcium
Pantothenate, USP) + 4.500 kg (Pyridoxine Hydrochloride, USP) + 10.000 kg (Cyanocobalamin, USP) + 35.000 kg (Lactose
Monohydrate) + 20.000 kg (Starch Regular, NF) + 4.000 kg (Magnesium Stearate, NF) = 118.500 kg per batch

(118.500 kg)(8 batches) = 948.000 kg

Case Questions: Answer the case questions assigned per group (refer to assignments below). Sets A and B represent different
scenarios in the workplace yet will follow the same set of questions.

RIBOFLAVIN, USP
SET A SET B
CASE 1 The first batch of Viplex Tablets is scheduled to be The first batch of Viplex Tablets is scheduled to be
dispensed today. dispensed today.

However, during weighing of Riboflavin lot R100021, only

4.450 kg was taken by the Dispensing Assistant from the
container.

1. Do you need to request additional lot/s from the Warehouse?

● No
2. Indicate the lot/s of Riboflavin that you will dispense.
● R100021
● R100022
3. Compute the quantity that you will dispense for each lot/s. Perform potency adjustment as necessary.
100%
● R100021 4.450 kg × 100%
= 4. 450 𝑘𝑔
100%
● R100022 10.550 kg × 100% = 10. 550 𝑘𝑔
4. Compute the new theoretical weight of granules considering the final quantity of Riboflavin that you will
dispense.
● 12.500 kg + 15.000 kg + 12.500 kg + 5.000 kg + 4.500 kg + 10.000 kg + 35.000 kg + 20.000 kg + 4.000 kg
= 118. 500 𝑘𝑔
CASE 2 The first two batches of Viplex Tablets are scheduled to be The first two batches of Viplex Tablets are scheduled to be
dispensed today. dispensed today.

Since your existing stocks in the dispensing area are Since your existing stocks in the dispensing area are
insufficient, you instructed the Raw Material Custodian to insufficient, you instructed your Raw Material Custodian to
request the lot R100023 from Warehouse. request the lot R100025 from Warehouse.

1. How many container/s of the specified lot will you request from the Warehouse? Avoid over-inventory.
● 1 container
2. Indicate the lot/s and quantities of Riboflavin that you will dispense for Viplex Batch 1 and Batch 2.
Perform potency adjustment as necessary.
● Viplex Batch 1
○ R100021 - 5.000 kg
○ R100022 - 10.000 kg
● Viplex Batch 2
○ R100022 - 10.000 kg
○ R100025 - 5.000 kg
3. Is requesting the specified lot the right decision? Why or why not?
● Yes, because in this particular case we apply the first expiry, first out rule. And we also consider its 100%
potency.

CASE 3 DR Corporation specifically instructed PPG DR Corporation specifically instructed PPG

Pharmaceuticals that only Riboflavin lots manufactured by Pharmaceuticals that only Riboflavin lots manufactured by
Harman Finochem shall be used for its Viplex Tablets. Prachi Pharmaceuticals shall be used for its Viplex
Tablets.

1. Based on existing stocks in Dispensing & Warehouse locations, how many batches of Viplex Tabs can be
produced?
● 4 batches

R100025 Prachi Pharmaceuticals 30.000 kg 100% potency

R100026 Prachi Pharmaceuticals 30.000 kg 101.2% potency

100.0%
30.000 kg × 101.2% = 29. 644 𝑘𝑔

Total available
30.000 kg + 30.000 kg = 60.000 kg

Amount needed
30.000 kg + 29.644 kg = 59.644 kg

1 batch = 15 kg Riboflavin 100.0% potency

60 𝑘𝑔
15 𝑘𝑔
= 4 𝑏𝑎𝑡𝑐ℎ𝑒𝑠

2. Will PPG Pharmaceuticals be able to meet the demand?

● No
3. Indicate the lot/s and number of containers per lot of Riboflavin that you will request from Warehouse.
● R100025 - 2 containers
● R100026 - 2 containers
4. Compute the quantities of each Riboflavin lot that you will dispense per batch. Perform potency adjustment as
necessary.
100%
● R100025 30. 000 𝑘𝑔 × 100%
= 15.000 kg
________________
2 batches
100%
● R100026 30. 000 𝑘𝑔 × 101.2% = 14.822 kg
_________________
2 batches
NAME OF INTERN Hernandez, Ericka Mae
Ilustre, Kylie
Lingao, Divina Amor
Macaraig, Hannah Rose
Maramot, Marjorie
Solis, Rea Xairus Jean
Sotelo, Ananda Marga
Villanueva, Nina Angelica

SCHOOL Lyceum of the Philippines University Batangas