SUNMORN FARMA COMPANY

Formula Tablet Kloramfenikol

Setiap 500 Mg Tablet Mengandung 
Kloramfenikol 250mg (Zat Aktif)
Mg Stearat 2% (Lubrikan)
Talk 8% (Pelincir)
Amylum Maydis 15% (Disintegran)
Pvp 5% (Pengikat)
Natrium Benzoat 0,02% (Pengawet)
Avicel 102 Ad 100% (Pengisi)

Company Structure
✨COOs
Latifah & Nurul

✨Researchers
Project Manager (Arif)
Pharmacologist (Annisa & Delyvia)
Toxicologist (Haida & Dhiya)
Medical Chemist (Sinta & Azra)
Clinical Researchers (Salma & Genfa)
Regulatory Profesional (Intan & Melani)
Data Analytst (Zulfa & Felisha)
Quality Control (Ginasti & Rysma)
Medical Writer (Nova & Resta)

✨Regulatory Affairs
Manager (Cahyody)
Medical Directure (Wana)
QA Specialist (Nanda & Rizky)
Medical Write (Difo & Nelvi)

✨Marketer
First Speaker (Julio)
Second Speaker (Sapta)
Designer (Rafif & Sofy)

✨Auditor
- Tania
- Fathiya
- Dinar
- Andi
- Mesi
- Kezia
- Rhindiani
 MEDICAL CHEMISTS

From : Medical Chemists (Sinta Pinarni and Azra Aqin Nabila Putri)

To : Muhamad Ad Muarif

Subject : Report on Validation of Ingredients for Chloramphenicol Tablet

Dear Muhamad Ad Muarif,

         We hope this email finds you well. We, Sinta and Azra, as medicinal chemists of our
company, would like to provide you with an update on our project to validate the efficacy and
safety of our antibiotic tablet ingredients for treating bacterial infection symptoms.

         Our team have reviewed the ingredients selected for the antibiotic tablet and agree that
they are mostly applicable for treating the diseases. However, we did have a slight disagreement
on the use of Avicel 101 or Avicel 102 as a filler. Ultimately, we decided to recommend the use
of Avicel 102, since Avicel 102 has good flow properties and has a high moisture content, so that
it can create a fairly strong bond between the drug molecule and the excipient.

         Additionally, we recommend in vivo testing to validate the efficacy of our selected
ingredients and determine the appropriate dosages. We believe this is an important step for the
pre-clinical study and will provide valuable information for our drug development process.

         Thank you for your continued support and guidance on this project. If you have any
questions or concerns, please do not hesitate to contact us.

Sincerely,

Sinta and Azra

 DATA ANALYST

From : Data Analyst Team (Felisha Rivanti and Zulfa Farah Fadilla)

To : Muhamad Ad Muarif

Subject : Data Analysis Report for Confirmatory Trial - Project Update

Dear Muhamad Ad Muarif,

I hope this email finds you well. I am writing to provide you with a comprehensive report
on the findings from the confirmatory trial conducted for our company's latest project. In this
email, I will summarize the key points discussed during my conversation with Zulfa, ensuring
that you are up to date with the latest results.

The trial involved 1200 ill adults with symptoms of headache and fever caused by
Salmonella typhi bacteria in Bandung. Our analysis revealed the promising efficacy of our
medicinal tablets, as 1080 out of 1200 participating patients experienced relief from their
headache and fever symptoms after taking the tablet. This accounted for significant improvement
for most of the participants.

However, it is important to recognize that adverse reactions have been reported among
some patients. Approximately 5% of participants (60 patients) experienced an adverse reaction.
According to clinical researchers, the most common is gastrointestinal discomfort such as mild
abdominal pain and nausea.

In addition, side effects were observed in 3% of participants (36 patients). The

researchers said that the events mainly consisted of mild allergic reactions such as skin rashes.
Additionally, serious side effects were reported by 2% of participants (24 patients). These
serious events include the occurrence of respiratory distress and difficulty breathing.

As requested, we will compile a detailed statistical report encompassing these findings,

including the efficacy of the chloramphenicol tablet, adverse reactions, adverse events, and
serious adverse events. Here is a graphic to illustrate:
 This report confirms that our project is heading to the right direction with 90% of
success. We also signal that our product can be produced in-mass with your approval to the
COO.

Thank you for your understanding and patience. If you have any questions or require
additional information, please do not hesitate to reach out. We remain dedicated to ensuring the
success of this project.

Best regards,

Felisha and Zulfa

 CLINICAL RESEARCHERS

From : Clinical Researchers (Genfa Iren Aldila dan Salma Ruhaimatul Badari)
To : Muhamad Ad Muarif
Subject : Data analysis report for chloramphenicol antibiotic drug trials – project
update

Dear Muhamad Ad Muarif,

I hope this email finds you well. I am writing you with a comprehensiv report on the
findings from Trial of chloramphenicol antibiotics drugs in typhoid fever patients. This project
itself is a new project from our company. In this email I will briefly explain the important points
that exist in this project.
Based on the trials conducted, medical record data was obtained from Fatmawati
Hospital, it was found that 244 patients affected by typhoid fever were children. The patients
consisted of 182 pediatric typhoid fever patients without comorbidities, as many as 53 pediatric
typhoid fever patients with comorbidities, and 9 pediatric typhoid fever patients who did not
complete treatment or patients were forcibly discharged. The demographic characteristics of
sufferers can be seen in Table 1.
Data analysis was then carried out on pediatric typhoid fever patients without
comorbidities to see the distribution of the type of antibiotic used, treatment class, payment
method, and distribution of hospitalization. The types of antibiotics given for the treatment of
typhoid fever can be seen in Table 2.
Table 1. Demographic characteristics of pediatric typhoid fever patients hospitalized at the
Child Health Department of Fatmawati Hospital Jakarta

Table 2. Distribution of types of antibiotics for treatment of hospitalized pediatric typhoid

fever patients
Table 3. Distribution of hospitalization days for pediatric typhoid fever patients at the
Child Health Department of Fatmawati Hospital Jakarta

Based on the type of antibiotic used in the treatment of typhoid fever in children, it can be
seen that chloramphenicol (53.55%) is still the main choice antibiotic given for typhoid fever in
the Child Health Department of Fatmawati Hospital, because the efficacy of chloramphenicol is
still recognized based on its effectiveness against Salmonella typhi besides the drug is relatively
cheap.
In this report shows that the effectiveness of chloramphenicol drugs compared to others is
still very large in typhoid fever patients with a percentage of 53.55%. Therefore we hope that
chloramphenicol products from this company can be mass produced with your approval to the
COO.
Thank you for the understanding and patience you have given us, and if you have
questions or need information about chloramphenicol antibiotics, then do not hesitate to contact
us. Because we will be dedicated to ensuring success regarding this project.
Best regards,
Genfa dan Salma
 PHARMACOLOGIST

From : Pharmacologist Team (Annisa & Delyvia)

To : Muhamad Ad Muarif
Subject : Report on the Pharmacology test for treating tyhoid caused by Escherichia coli
bacteria using the antibiotic chloramphenicol
Dear Mr. Arif,
I hope this email finds you in health. I am writing to provide you with a detailed report on the
pharmacology test (vivo testing) conducted for our company's current project. The testing aimed
to assess the drug's efficacy and potential side effects antibiotic chloramphenicol.
In accordance with our discussion, my colleague Delyvia and I carried out the testing on four
adult: Nain (25 year old), Baim (30 years old), Bunga (28 years old), and Rifat (23 years old).
We administered doses of the cough syrup to each person and closely observed their reactions
over the course of an hour.
During the testing, we encountered varying responses and challenges. Bungaexperienced side
effects, nausea and vomiting, so that the absorption of the drug in the body was reduced. To
address this, we immediately stopped giving. Likewise, Rifat also experienced side effects,
namely allergies, and we followed the same procedure as Bunga, stopping use.
On the other hand, Baim and Nain did not encounter any issues with the administration of the
antibiotic chloramphenicol . They responded positively, with no adverse effects observed. They
responded positively, with no observed side effects. This shows that everyone's immune system
affects their ability to fight target bacteria and the absorption of drugs in their bodies is quite
good.
based on these findings, we believe it would be beneficial to involve our toxicologist team to
gain further insights into the adverse reactions experienced by Bunga and Rifat. Their expertise
will help us understand the underlying causes and address any potential concerns.
Thank you for your attention to this matter, and we look forward to your guidance on the next
steps to take based on these findings.
Best regards,
Pharmacologist Team
 QUALITY CONTROL PROFESSIONALS

Team : Quality Control Professionals (Ginasti & Rysma )

Instruction : Provide a set of QC documents to be audited later
Example : Documents of drug manufacturing (personnel of the company, factory
equipment, supplier control, and manufacturing process of the drug

I. Personnel of the Company (COO and researchers)

No. Position and Name Responsibilities Current work
1. Chief Operating Supervise all activities  Organize members, assist
Officer (Sayidatul of the current project whoever needs, and keep in
Latifah and Nurul touch with stakeholders
heryati)
2. Medical Writers (Nova Prepare and review  Write clear and concise
Arsita and Resta) scientific documents summaries of the study
findings to develop the drugs
3. Medicinal Chemists Design and synthesize  Optimize the chemical
(Sinta Pinarni and Azra novel compounds or structures of the ingredients to
Aqin) modify existing natural improve bioavailability and
compounds to enhance pharmacokinetics.
the efficacy and safety  Work closely with the basic
of tablets scientists and pharmacologists
to ensure the compatibility of
the synthesized compounds
with the desired formulation.
4. Pharmacologists Conduct preclinical  Assess the therapeutic effects
(Annisa Rumaisha and studies to evaluate the and safety profiles of the
Delyvia Aprillyanti) pharmacological ingredients using in vitro and
properties of in vivo experiments.
chloramphenicol tablets  Provide guidance on dosage,
administration, and potential
drug interactions.
5. Toxicologists (Haida Evaluate the safety of  Assess the potential adverse
azahrani and dhiya h the tablets by effects and toxicity risks
w) conducting toxicity associated with the
studies. ingredients.
 Provide recommendations on
safe dosage levels and
formulation adjustments to
 ensure the product's safety for
children under 5 years old.
6. Clinical Researchers Design and conduct  Collect and analyze data on
(Santika Puja Annisa clinical trials to evaluate the syrup's effectiveness in
and Lani Maelani) the efficacy and safety relieving cough symptoms and
of the tablet antibiotic improving overall health.
all in young children.
 Collaborate with healthcare
professionals and caregivers to
monitor patient outcomes and
ensure compliance with
ethical and regulatory
standards.
7. Data Analysts (zulfa Analyze and interpret  Apply statistical methods to
and felisha) data from preclinical evaluate the efficacy, safety,
and clinical studies. and quality control data.
 Generate reports and
summaries to support decision-
making and regulatory
submissions
8. QC Professionals Develop and implement  Perform tests and inspections
(Ginasti and Rysma) quality control protocols to ensure the product meets
for the tablet antibiotics established quality standards.
manufacturing process.  Collaborate with other team
members to address any
quality-related issues and
implement corrective actions.
9. Regulatory Navigate regulatory  Prepare and submit necessary
Professionals (Intan requirements and ensure documentation for regulatory
and Melani) compliance with approvals and licenses.
relevant laws and  Stay updated on the latest
guidelines. regulations and guidelines
related to pediatric medicines
and tablet antibiotics

II. Factorial Equipment of Producing All-natural Cough Syrup for Children Under
Five Years-old (Only the most important)
No. Tools / Equipment Quan- Function Maintenance
tity
1. 2 Blending the regular cleaning
kloramfenikol, Avicel, and sanitization
and Calcium Stearate
together.

Double Cone blander

2. 3 Put the mixed results routine inspection
into the funnel and the and maintenance
tool will print tablets of heating
elements,
temperature
controls, and seals

Compressing Tablet killian

Ruts
3. 2 serves as a drug coating regular
so that the drug does not replacement of
corrode and temperature filter media and
protection thorough cleaning

Filtration system
4. 2 regular
Convert Crystalline Po maintenance of
conveyor belts,
wder Into Granular Tabl filling
mechanisms.
ets.

Tablet Printing machine

 5. 2 Seals tablets securely to inspections and
maintain product maintenance of
freshness and prevent seals, conveyor
contamination systems, and
temperature
controls

Packaging and storing

machinery

III. Supplier Control (Monthly Production)

Monthly production : 25 batches, of 12 tablets
Each batch requires : 75 grams Kloramfenikol,
75 grams Avicel, and
50 grams of Calcium stearate.
No. Tools / Equipment Quantity Quantity Quantity Supplier
/ single / batch / month
package
1. 100 75 2,25 "PT Nuraku Jaya
miligram grams kilograms Abadi Made In
Indonesia

kloramfenikol
2. 100 75 2,25 "PT Niraku Jaya
miligram grams kilograms Abadi Made In
Indonesia

Avicel
3. 50 15 450 "PT Niraku Jaya
miligram grams grams Abadi Made In
Indonesia”

Calcium stearate
IV. Manufacturing Process
The process of making chloramphenicol tablets using these tools/equipment is usually
carried out in the following steps:
1. Preparation: Gather the necessary materials, including chloramphenicol, avicel,
and calcium stearate. make sure the ingredients are of high quality.
2. Mixing: Start by mixing the chloramphenicol, avicel, calcium stearate and the
required ingredients in a bowl. Mix the ingredients thoroughly until well blended.
3. evaluation: the mixture is evaluated first to determine the biological, chemical and
physical properties of the preparation.
4. printing : After the mixture is weighed and mixed, then it is transferred to the
tablet printing machine
5. Quality Control: Use pH meters to ensure the desired acidity level, refractometers
to measure the sugar content, and viscosity measurement devices to monitor the
consistency.
6. primary packaging: Utilize thick aluminum material that has been labeled with the
description of 250 mg per tablet
7. sekunder Packaging : put it in a box that has been given a description and
storedand prevent contamination.
 REGULATORY PROFESSIONALS

Team : Regulatory Professionals (Intan Dwita and Melani)

Instruction : Make a Standard Operating Procedure (SOP) for manufacturing the drug
(highlight the passive voice sentences). Optionally, it could be correlated with the
QC documents.

Example : SOP in the manufacture of chloramphenicol drug tablets

NOTE: the sky blue-highlighted points are correlated with the QC documents, while the purple-
words points are external variables from the QC documents.

1. Raw materials preparation:

 The required ingredients are gathered and verified for quality and quantity.
 Raw materials are carefully and weighed carefully according to the formulation
specifications.
 The materials are labeled and properly stored in designated areas.
2. Mixing and formulation:
 Materials are transferred to the mixing vessel under controlled conditions.
 The ingredients are mixed together until a homogeneous mixture is obtained.
 Formulations are carefully checked for any deviations or inconsistencies.
3. Evaluation 1:
 The mixture is evaluated first to determine the physical properties of the preparation
 Valuated by compressibility testing, mesh and others
4. Printing:
 After the dough is weighed and mixed, then it is transferred to the tablet printing
machine.
 Tablets ready to print
5. Evaluation 2:
 Tablets that have been printed are re-evaluated
 Evaluation by testing tablet hardnes, size uniformity and others
6. Quality control:
 Samples from each batch are collected for quality testing as per established
protocols.
  The samples are sent to the quality control department for analysis and evaluation.
 The results are recorded, and the batch is released for distribution only if it meets the
specified quality standards.
7. Documentation:
 Detailed records of each manufacturing step, including raw material information,
formulation details, and quality control results, are maintained.
 All relevant information is accurately documented and archived for future reference
and regulatory compliance.
8. Equipment maintenance and cleaning:
 The manufacturing equipment is regularly inspected, cleaned, and calibrated to
ensure proper functioning and accuracy.
 Maintenance activities and cleaning procedures are performed according to
predefined schedules and documented accordingly.
9. Adverse event reporting:
 Any adverse events or product complaints received are promptly recorded and
reported to the appropriate authorities in compliance with regulatory requirements.
10. Personnel training and hygiene:
 All personnel involved in the manufacturing process receive adequate training on
Good Manufacturing Practices (GMP) and the SOPs.
 Personal hygiene practices, including proper gowning, handwashing, and
sanitization, are strictly followed by all manufacturing staff.

MARKERTER
Design Of Chloramphenicol Tablet Package