BRDG3

Pharmaceuticals

Group 1

Albao, Barbie Stef P.

Barbosa, Glyza

Eracho, Giulia

Jamisola, Gabriela Ann

Regis, Rhea

Reynera, Deon Shane

Ms. Neri Fabillo, RPh

 Teacher

PHARMACY ADMINISTRATION, LEADERSHIP

AND MANAGEMENT PROJECT

1. INTRODUCTION

In this world where the incidence of diseases is on the rise, the demand for drugs,
innovative research for new medicines, and proper dispensing of drugs have become a critical
missing piece in the economy and the health industry. Recognizing this gap, the BRDG3
Pharmaceuticals was established to address these pressing needs comprehensively.
The company, named after its founders Barbie, Rhea, Deon, Gabriela, Giulia, and
Glyza, is dedicated to providing high-quality, affordable drugs. Moreover, it also focuses on
developing new formulations of medicines through research targeting both treatable and
untreatable diseases specifically HIV (Human Immunodeficiency Virus).
By ensuring that essential medications are accessible to all and continually advancing
medical science, BRDG3 Pharmaceuticals aims to bridge the gap in the pharmaceutical
industry and improve the quality of life worldwide.

2. THE COMPANY’S LOGO

The official logo of BRDG3

 The official company logo symbolizes several things: the initials of the owners of
BRDG3, the symbol of pharmacy, color symbolism, and the overall picture, which shows the
company’s objectives.

Based on the picture shown above, a visualization of the letters B, R, D, G, G, G can

be seen, which are the first letters of the names of the owners: Barbie, Rhea, Deon, Giulia,
Gabriela, and Glyza, thus the name BRDG3.

The Bowl of Hygeia, the most widely recognized symbol of pharmacy, is also
included in the official logo. Hygeia was the daughter of the god of health. Our company
incorporated the Bowl of Hygeia as it symbolizes healing, professionalism, and a trusted
tradition in pharmaceutical care.
Furthermore, the colors shown in the logo have color symbolisms with purple symbolizing
prestige, quality, calmness, and healing. Purple is linked to healing and soothing, reflecting
the therapeutic nature of the medications; it also implies high-quality products. Meanwhile,
the color blue is a symbol for trust, which implies that our company can be trusted with
pharmaceutical products. Then, the color green symbolizes safety such as the medicines that
our company manufacture. Lastly, the color yellow symbolizes optimism and positivity,
reflecting the healing and hopeful nature of pharmaceutical care.

Additionally, the bridge in our logo symbolizes connection, accessibility, guidance,

and community. As pharmacists, it is our duty to connect our patients to pharmaceutical
products, emphasizing accessibility to healthcare products. The bridge also symbolizes
guidance which suggests that pharmacists are the guiding light to the patients’ journey by
offering expert advice and assistance. And, as pharmacists, we must collaborate with our
community to promote overall health and wellness.
 Finally, an image of a person can be visibly seen, symbolizing the main objective of
our company: prioritizing the well-being of the people. With our company, we craft health,
one pill at a time.

3. MISSION

Our mission is to manufacture innovative, high-quality pharmaceutical

products that ensure safety, affordability, and efficacy, ultimately enriching the lives of our
customers.

4. VISION

To become one of the leading drug manufacturers of antiretroviral (HIV) in the next
five years without compromising the quality and safety to be delivered.

5. PRODUCT AND SERVICE

BRDG3 Pharmaceuticals, as a manufacturing corporation, provides the following

product and services:

● Anti-HIV medicines. Human Immunodeficiency Virus (HIV) is a virus that

attacks the body’s immune system, which can lead to acquired
immunodeficiency syndrome (AIDS) if not treated immediately. This virus has
been detected over the years and has led so many people to get AIDS. To
prevent this from happening, a countermeasure was made, antiretroviral drugs,
which can prevent HIV from reproducing, were produced. Anti-HIV
medicines produced by this corporation have better qualities. One of them
would be, it quickly alleviates HIV symptoms and pain within 12 hours of
intake. Another would be its proper dissemination of the right information.
This medicine will be in different forms and strengths. The products will also
have the following information in their packages to guide the customers or
consumers: generic name of product, brand name, dosage form and strength,
manufacturing information including the dates of manufacture and expiration
date, and the name of the company and its address, the ingredients utilized,
uses of the medicine, precautions, guide to the dosage strengths taken by age,
and shows FDA’s approval.

● Proper dispensing service. Aside from anti-HIV medicines, BRDG3

Pharmaceuticals provides better ways to dispense the product. One would be
sealing the product well, then, handling the package with care as to not get
 dents on the box. Another would be promoting and distributing the medicines
not just in local area community pharmacies but also nationally and
internationally.

6. A 5-YEAR OBJECTIVE OF THE COMPANY

Launch new and first-in-class drugs for HIV (human immunodeficiency virus) by
2027, achieving a combined market share of 20% within three years of launch and securing
long-term contract manufacturing agreements with international pharmaceutical companies
by 2025, increasing service revenue by 25% year-over-year.

7. ORGANIZATIONAL STRUCTURE AND COMMITTEES

8. OBJECTIVES OF DEPARTMENT COMMITTEES

The list below indicates the objectives of each department of the BRDG3
Pharmaceuticals:
Chief Executive Officer (CEO): Strategize future plans, make informed financial decisions,
foster a culture of motivation and teamwork among employees, and steer the company
towards success by meeting the demands and needs of the target market.

Research and Development (R&D): Lead comprehensive research efforts in formulating new
medicines and enhancing existing products, driving innovation in drug development to
address both treatable and untreatable diseases effectively

Engineering Department: Facilitate the production of high-quality drugs by estimating

production costs, approving designs and budgets, and innovating facility technologies
through rigorous research and development processes
Quality Control Department: Uphold rigorous quality standards by inspecting products,
testing new-release medicines, measuring materials, monitoring operations, and
recommending adjustments to ensure adherence to production standards and continuous
improvement in the production process.

Supply Chain Management: Optimize the movement of goods, ensure timely delivery,
implement effective supply chain strategies, monitor inventory levels, and nurture strong
supplier relationships to support the company's mission of providing high-quality, affordable
drugs worldwide.

Marketing and Sales Department. Drive market penetration, increase brand awareness, and
achieve sales targets through strategic marketing initiatives and effective sales strategies,
ensuring broad accessibility to BRDG3 Pharmaceuticals' products.

Human Resources Department. Attract, retain, and develop top talent by implementing HR
policies, fostering a positive work environment, ensuring compliance with labor laws, and
promoting continuous professional development to support the company's mission and
objectives.

Finance and Accounting Department. Maintain financial health by managing budgets,

overseeing financial planning and analysis, ensuring accurate financial reporting,
implementing robust financial controls, and mitigating risks to support the company's
sustainable growth and profitability.

9. DUTIES AND RESPONSIBILITIES OF DEPARTMENT COMMITTEES

1.) Rhea Regis - Chief Executive Officer (CEO)

Rhea, as the CEO, provides leadership and direction for the company. She is
responsible for establishing long-term goals in which the CEO plans business
strategies. Monitoring all the departments is also her responsibility to ensure they are
aligned with the company's objectives.
2.) Barbie Albao - Research and Development Department (R&D)
Barbie, as the Research and Development Department Head her
responsibilities encompass overseeing the discovery and development of new drugs,
from initial research to pre-clinical trials, while ensuring compliance with regulations
and maintaining the highest standards for safety and efficacy. She also manages the
R&D budget, oversees clinical trials, and collaborates with other departments, such as
marketing, to ensure successful product launches.

3.) Giulia Eracho - Engineering Department Head

Giulia, as the Engineering Department Head, is responsible for the intricate
planning and coordination of projects, as well as the oversight of teams and
exploration of new products. Additionally, she manages the production flow of goods
and services. It includes logistics, inventory, and the process of converting raw
materials into a final product. Her duties include the development of strategies,
effective budget management, and ensuring the successful completion of projects.
Close collaboration with teams and other management personnel is paramount,
necessitating strong analytical, communication, and organizational skills.

4.) Gabriela Jamisola - Marketing and Sales Department Head

Gabriela, as the head of the Marketing and Sales Department, is responsible
for formulating marketing strategies to enhance brand recognition and promote
pharmaceutical products to healthcare professionals and, where applicable, to
customers/patients. This encompasses conducting market research, determining
product positioning, and overseeing sales channels to ensure effective product
distribution and revenue generation.

5.) Deon Reynera - Finance and Accounting Department Head

Deon, as the head of the Finance and Accounting Department, is responsible
for managing all financial activities, including budgeting, cash flow management, and
financial reporting. It ensures the accuracy of financial statements and internal
controls to secure the company's financial health. Additionally, she manages tax
obligations and may participate in financial planning and fundraising activities crucial
for the company's growth and sustainability.

6.) Glyza Barbosa - Human Resources Department Head

Glyza, as the Human Resources Department Head, in which her duties involve
managing the entire employee lifecycle, from recruitment and onboarding to training,
and development, ensuring compliance with labor laws and regulations, fostering a
positive work environment, and maintaining strong employee relations.
10. STAGES AND ACTIVITIES OF PLANNING

Step 1: Develop an objective.

Step 2: Gather information.
Step 3: Form an alternative plan.
Step 4: Create and delegate tasks to meet the objectives.
Step 5: Identify the resources needed.
Step 6: Create a timeline of activities.
Step 7: Finalize the plan.
Step 8: Execute the plan.
Step 9: Monitor and assess the progress and performance of the team.
Step 10: Give feedback and rewards.

11. BUDGET MANAGEMENT

Start-up Cost: 14,800,000

Start-up Budget

Equipment 5,000,000 33.79 %

Building 2,500,000 16.89 %

Production Department 1,000,000 6.76%

Location 1,000,000 6.76 %

Utilities 1,000,000 6.76 %

Research & Development 800,000 5.41 %

Department

Quality Control 700,000 4.73 %

Department

Human Resources and 700,000 4.73 %

Labor Department
Finance & Accounting 600,000 4.05%
Department

Marketing & Sales 500,000 3.38 %

Department

Raw Materials 350,000 2.36 %

Engineering Department 250,000 1.69 %

Supply Chain Management 200,000 1.35 %

Emergency Funds 200,000 1.35 %

12. MARKETING STRATEGY

Pharmaceutical marketing strategy uses different marketing approaches to promote its

product. Here are various ways to do so:

1) Digital marketing:

· Search engine optimization- Provides quality and quantity of traffic to a

website from search engines.
 · Social media marketing- Makes use of different social media platforms to
promote the company and its product.

· Website Personalization- designing a website provides accessibility and easy

use for potential clients.

2) Convention and Events: Participating in trade shows and events allows manufacturers
to showcase their products and build connections in the field of pharmaceutics.

3) Medical Representative: Professional responsible for promoting and selling

pharmaceuticals and products while establishing a good relationship with healthcare
professionals.

13. INVENTORY MANAGEMENT

This section details the meticulous procedures to track and manage every single item
that comes in and out of the company.

1) Strict receiving and logging procedure:

Incoming items or supplies must be documented and monitored to maintain
precise records, enhance accountability, and adhere to established protocols.

2) Lot tracking system

Each batch of raw materials and finished drugs is allocated a distinct identifier,
typically a lot number or code. It serves as an essential tool for ensuring product
quality, safety, and regulatory compliance in the company.

14. FORECAST SALES AND GOAL RESULTS

The indicators below will tell that the company is doing well in the coming years:

Interest rates. It represents the surcharge levied by a lender on a borrower atop the principal
sum for asset utilization, underscoring the corporation's commitment to fully reimburse the
borrowed capital within a three-year timeframe, a pledge contingent upon the successful
launch of the new drug.

Worker productivity. It serves as a quantifiable gauge of the output of goods and services by a
collective workforce within a specified interval, and constitutes a pivotal metric scrutinized
by economists; within this corporation, employees are poised to exhibit exemplary
performance, yielding heightened production of premium anti-HIV medications and enhanced
dispensing services.

Retail sales. An escalation signifies a robust expansion in sales activity, indicative of a

thriving market environment; with heightened consumption of the newly introduced
medication, stock levels are anticipated to surge, yielding favorable outcomes for
shareholders.

Consumer confidence. An increased rate signifies heightened satisfaction with the

pharmaceutical product, affirming its efficacy, efficiency, and overall satisfaction; this
underscores the pronounced optimism consumers harbor regarding the accessibility and
affordability of the anti-HIV medication.

Unemployment rate. A decline in this signifies a greater prevalence of gainfully employed

individuals; with the anticipated introduction of numerous new drugs within the next five
years, both the market and the economy stand to gain substantially, potentially culminating in
celebratory events marking the diminished prevalence of unemployment among Filipino
citizens.

The sales would increase in 5-year time with significant results. The tables below show the
yearly timeline of forecast sales and goal results.

14.1 Forecast Results Timeline

Year No. Results Forecast
Year 1 ● Anti-HIV research commencement
● Successfully made a new formulation for the HIV drug
● Plan for marketing of the new drug

Year 2 ● Commence marketing plan

● Mass production of drugs
● Successful launch of new first-class HIV drugs

Year 3 ● Pharmaceutical companies invest

● Company growth
● Employ new workers

Year 4 ● Improved quality of first-class HIV drugs

 ● Launch of improved quality of first-class HIV drugs
internationally
Year 5 ● Establish branches around the Philippines
● Anticancer research commencement

15. COMPANY POLICY FOR PERSONNEL

● The Virtue Policy. Uphold integrity, honesty, professionalism, and respect for
colleagues.
● Documentation Policy. Document and record everything such as the
distribution and the test results.
● Safety Policy. Use protective equipment and gear when handling medications
or hazardous substances; Label, secure, and store drugs properly to avoid mix-
ups.
● Hygiene and Sanitation Policy. Clean and disinfect the area regularly to
prevent the spread of infectious diseases.
● Feedback Policy. Immediately report accidents to identify the course of action
to be taken.
● No Smoking Policy. No smoking/vaping on the company premises. ● No
Eating/Drinking Policy. No eating or drinking in the laboratory.
● Disposal Policy. Dispose properly of what was used during the laboratory.
● Quality Control Policy. Procedures must be detailed to ensure quality and
purity of the drugs.
● GMP Policy. Ensure the consistent quality of the products according to quality
standards.
● Natural Policy. Minimizing the company’s carbon footprints by sustainable
practices and good waste management.

16. COMPANY POLICY FOR OPERATION

Consignment Agreement: The consignee (distributor) receives the items to be sold, with his
commission serving as the mark-up. The consignee is then required to return the products to
the consignor (manufacturer) if they are unsold or to remit the sale earnings within the
predetermined time frame.
Counterfeit Product: The manufacturer shall be liable for any products that are deliberately
and fraudulently mislabelled with respect to and/or source and may include products with the
correct ingredients or with wrong ingredients, without active ingredients, with insufficient
active ingredients, or with fake packaging.
First Expiry, First Out: Stocks with the earliest expiry date shall be disposed of and/or used
before an item with a later expiry date is disposed/or used.

Expired Good Return Policy: Expired product must be within six (6) months of expiration
but cannot be out of date by more than six (6) months. Products that are outside of this twelve
(12) month window will not be credited.

17. PERSONNEL HIRING PROCEDURE AND QUALIFICATIONS

Chief Executive Officer (CEO)

Qualifications:
● Extensive experience in pharmaceutical management and leadership.
● Strong background in strategic planning and financial decision-making.
● Proven ability to motivate and lead a diverse team.
● Excellent communication and liaison skills.
● MBA or equivalent advanced degree preferred.

Research and Production Department Head

Qualifications:
● Ph.D. or Master's degree in Pharmaceutical Sciences or a related field.
● Significant experience in drug research and production management.
● Proven track record in developing new formulations of medicines.
● Strong leadership and project management skills.

Workers under this department:

Production Leader’s Assistant
Qualifications:
● Bachelor's degree in Industrial Engineering or related field.
● Experience in production planning and operations.
● Strong organizational and multitasking skills.

Production Planner
Qualifications:
● Bachelor's degree in Supply Chain Management, Business, or related
field.
● Experience in production scheduling and inventory management.
● Strong analytical and problem-solving skills.

Technical/Industrial Leader
Qualifications:
● Bachelor's degree in Industrial Engineering, Mechanical Engineering,
or related field.
 ● Experience in technical operations and industrial processes.
● Strong project management and leadership skills.

Quality Assurance Manager

Qualifications:
● Bachelor's degree in Quality Management, Pharmaceutical Sciences, or
related field.
● Experience in quality assurance within the pharmaceutical industry.
● Knowledge of regulatory standards and compliance.

Research and Development Committee Leader

Qualifications:
● Ph.D. or Master's degree in Pharmaceutical Sciences or related field.
● Extensive experience in R&D, preferably within the pharmaceutical
industry.
● Strong leadership and innovative thinking skills.

Quality Control Department Leader

Qualifications:
● Bachelor's degree in Chemistry, Biology, or related field.
● Experience in quality control and laboratory management.
● Strong analytical and attention to detail skills.

Engineering Department Head

Qualifications:
● Bachelor's degree in Engineering (Chemical, Mechanical, or
Industrial).
● Significant experience in pharmaceutical engineering and facility
management.
● Strong leadership and project management skills.

Workers under this department:

Leader of Supply Chain Management
Qualifications:
● Bachelor's degree in Supply Chain Management or related field. ●
Extensive experience in supply chain coordination and logistics.
● Strong analytical and problem-solving skills.

Engineering Design Leader

Qualifications:
● Bachelor's degree in Engineering Design or related field.
● Experience in designing pharmaceutical production facilities.
● Strong technical drawing and design skills.
Installation and Maintenance Committee Leader
Qualifications:
● Bachelor's degree in Mechanical or Electrical Engineering.
● Experience in the installation and maintenance of pharmaceutical
equipment.
● Strong technical and problem-solving skills.

Marketing and Sales Department Head

Qualifications:
● Bachelor's degree in Marketing, Business Administration, or related
field.
● Extensive experience in pharmaceutical marketing and sales.
● Strong leadership and strategic planning skills.

Workers under this department:

Brand/Advertising Creative Committee Leader
Qualifications:
● Bachelor's degree in Marketing, Advertising, or related field.
● Experience in brand management and advertising.
● Strong creative and strategic thinking skills.

Promotions/Media Committee Leader

Qualifications:
● Bachelor's degree in Marketing, Communications, or related field.
● Experience in promotions and media relations.
● Strong communication and media planning skills.

Public Relations Leader

Qualifications:
● Bachelor's degree in Public Relations, Communications, or related
field.
● Experience in public relations and corporate communications.
● Strong networking and interpersonal skills.

Trade Marketing Leader

Qualifications:
● Bachelor's degree in Marketing, Business, or related field.
● Experience in trade marketing and sales promotions.
● Strong analytical and negotiation skills.

Market Analyst
Qualifications:
● Bachelor's degree in Marketing, Business, or related field.
● Experience in market analysis and research.
 ● Strong analytical and data interpretation skills.

Finance and Accounting Department Head

Qualifications:
● Bachelor's degree in Finance, Accounting, or related field.
● Extensive experience in financial management and accounting.
● Strong leadership and analytical skills.
● CPA or equivalent certification preferred.

Workers under this department:

Controller
Qualifications:
● Bachelor's degree in Accounting or Finance.
● Experience in financial reporting and control.
● Strong organizational and analytical skills.
Treasurer
Qualifications:
● Bachelor's degree in Finance or Business Administration.
● Experience in treasury management and financial planning.
● Strong analytical and strategic planning skills.
Internal Audit
Qualifications:
● Bachelor's degree in Accounting, Finance, or related field.
● Experience in internal auditing and compliance.
● Strong attention to detail and analytical skills.

Managerial Accountant Leader

Qualifications:
● Bachelor's degree in Accounting or Finance.
● Experience in managerial accounting and budgeting.
● Strong analytical and decision-making skills.

Financial Accountant Leader

Qualifications:
● Bachelor's degree in Accounting or Finance.
● Experience in financial accounting and reporting.
● Strong attention to detail and compliance skills.

Tax Accountant Leader

Qualifications:
● Bachelor's degree in Accounting or Taxation.
 ● Experience in tax accounting and compliance.
● Strong knowledge of tax laws and regulations.

Human Resources Department Head

Qualifications:
● Bachelor's degree in Human Resources Management, Business
Administration, or related field.
● Extensive experience in HR management and employee relations.
● Strong leadership and organizational skills.

Workers under this department:

Team Leader of Training Group
Qualifications:
● Bachelor's degree in Human Resources, Education, or related field.
● Experience in training and development.
● Strong instructional and leadership skills.

Leader of Recruiting Team

Qualifications:
● Bachelor's degree in Human Resources, Business Administration, or
related field.
● Experience in recruitment and talent acquisition.
● Strong interpersonal and networking skills.
Office Support Committee Leader
Qualifications:
● Bachelor's degree in Business Administration or related field. ●
Experience in office management and administrative support.
● Strong organizational and multitasking skills.

Compensation Committee Leader

Qualifications:
● Bachelor's degree in Human Resources, Finance, or related field.
● Experience in compensation and benefits management. ● Strong
analytical and decision-making skills.
●
These qualifications ensure that each leader and worker in BRDG3
Pharmaceuticals is equipped with the necessary skills and experience to fulfill their
roles effectively and contribute to the company's mission of providing high-quality,
affordable drugs and advancing medical science.

17.1 Procedure in hiring of personnel for vacant positions

 To ensure the selection of qualified personnel for all departments and
positions, BRDG3 Pharmaceuticals will follow a comprehensive and standardized
hiring process. Below are the detailed steps:

1. Listing Down Job Requirements

● Identify the vacancy: Department heads notify HR of the need to fill a
position.
● Job analysis: Conduct a thorough analysis of the job to determine specific
tasks, responsibilities, and qualifications.
● Create a job description: Detail the job title, duties, required qualifications,
skills, experience, and any other relevant information.
● Approval: Get approval from relevant executives to proceed with the
recruitment.

2. Knowing Sources of Prospects

Internal sources: Consider current employees for promotions or lateral moves.
External sources: ● Post job ads on the company’s website, job boards, and
professional networks.
● Partner with recruitment agencies and attend job fairs.
● Reach out to universities and professional organizations.

3. Applicants Filling Out Application Forms and Submitting Supporting

Documents ● Application process:
● Interested candidates fill out application forms available on the
company website.
● Submit required documents such as resumes, cover letters, transcripts
of records, NBI and police clearance, and other certifications.
● Initial screening: HR reviews applications to ensure they meet the
basic requirements.

4. Targeted Selection Interview

● Scheduling interviews: HR schedules interviews with shortlisted candidates.
● Interview panel: Form a panel consisting of HR, the department head, and
other relevant team members.
● Interview process: Conduct structured interviews focusing on job-specific
competencies and behavioral questions to assess fit with the company culture
and role requirements.

5. Summarizing Interview Evidence

● Interview notes: Panel members document their observations and key points
from the interviews.
● Evaluation forms: Use standardized evaluation forms to rate candidates on
various criteria.
 ● Panel discussion: Convene a meeting to discuss each candidate’s strengths and
weaknesses based on the interview evidence.

6. Checking References and Background Interview

● Reference checks: Contact previous employers and professional references
provided by the candidate to verify their work history, skills, and performance.
● Background interview: Conduct additional interviews if necessary to clarify
any concerns or gather more information.

7. Checking Physical Fitness

● Medical examination: Arrange for candidates to undergo a medical
examination to ensure they meet the physical requirements of the job.
● Health clearance: Obtain health clearance from a certified medical
professional.

8. Totalling the Applicant's Score

● Scoring system: Combine scores from the interview, reference checks, and
medical examination to create an overall score for each candidate.
● Final decision: The hiring panel reviews the scores and makes the final hiring
decision based on the total score and overall fit for the role.
● Approval: Obtain final approval from senior management if necessary.

18. COMPANY OPERATIONAL PROCEDURES

1. Production Procedures:

● Batch Manufacturing Procedures:

0 Raw material receiving and inspection
○ Equipment setup and calibration
○ Mixing, processing, and packaging steps
○ In-process quality control checks
○ Final product testing and release
● Cleaning and Sanitation Procedures:
○ Gathering of supplies and clearing the area
○ Removing debris, disassembling, and scrubbing surfaces
○ Disinfecting equipment and the area and applying appropriate contact time
○ Thoroughly rinse surfaces with clean water
○ Ensuring surfaces are completely dry
○ Inspecting, reassembling, and documenting the process for quality control and
compliance
 ● Equipment Maintenance Procedures: These outline the preventative maintenance
schedules for all production equipment. This ensures equipment reliability and
minimizes production downtime.
0 Inventory of equipment and prioritize based on importance
○ Develop preventative maintenance schedules for each item
○ Document SOPs for each maintenance task
○ Execution of tasks and maintenance and recording activities meticulously
○ Monitor performance, adjust schedules, and continuously improve procedures
based on feedback and data.

2. Quality Control Procedures:

● Sampling and Testing Procedures: This details the procedures for sampling finished
products and conducting various quality control tests. These tests ensure the product
meets established specifications and regulatory requirements.
➢ Perform a number of quality control tests on the samples to evaluate their
identity, potency, purity, and microbial content, among other characteristics.
➢ Employ the proper testing methods and techniques as directed by the testing
procedures and pharmacopeial standards.
➢ Follow Good Manufacturing Practices (GMP) and Good Laboratory Practices
(GLP) when conducting tests in a controlled laboratory setting with personnel
who have received training.
● Non-conformance Management Procedures: This outlines how to handle situations
where a product does not meet specifications. It includes procedures for investigating
the cause of the non-conformance, taking corrective action, and preventing future
occurrences.
➢ Identification: Inspectors, operators, or QC personnel identify a potential
nonconformance during production, packaging, or testing.
➢ Documentation: The identified non-conformance is documented in a
designated form, capturing details like:
0 Date and time of identification.
○ Product batch number and description of the non-conformance.
○ Quantity of potentially affected products.
➢ Containment: Immediate action is taken to prevent further non-conforming
products from entering the manufacturing process.
➢ Investigation: The team investigates the root cause of the non-conformance
through:
0 Reviewing production records and equipment logs.
○ Analyzing raw materials or samples.
○ Interviewing personnel involved in the production process.
 ➢ Corrective Action: Based on the investigation findings, corrective actions are
implemented to address the root cause and prevent future occurrences.
0 Adjusting manufacturing processes.
○ Recalibrating equipment.
○ Revising training procedures for personnel.
● Document Control Procedures: This ensures that all quality control documents, such
as test methods and calibration records, are properly controlled, reviewed, and
updated. All activities throughout the non-conformance management process are
documented, including:
➢ Investigation reports.
➢ Corrective action plans.
➢ Disposition decisions.

➢ Verification results.

3. Inventory Management Procedures:

● Raw Material Inventory Control: This outlines procedures for receiving, storing,
and issuing raw materials. It ensures proper stock levels are maintained and materials
are handled according to specific requirements.
➢ Receiving: Upon arrival, raw materials are inspected against pre-defined
specifications and accompanying documentation to verify:
○ Identity of the material.
○ Quality and purity.
○ Quantity received.
○ Compliance with storage requirements (temperature, light sensitivity,
etc.).
➢ Quarantine: Received materials are quarantined in a designated holding area
until they are officially released for use in production.
➢ Storage: Released materials are stored under appropriate conditions according
to their specific requirements (e.g., temperature-controlled rooms, flammable
material storage).
➢ Issuing: A documented issuing procedure ensures raw materials are dispensed
for production following a first-in-first-out (FIFO) method to minimize the
risk of using expired materials.
➢ Inventory Monitoring: Inventory levels are monitored regularly to identify
potential stockouts or excess materials.
➢ Reconciliation: Regular inventory reconciliations are performed to compare
physical stock counts with the inventory management system records.
➢ Documentation and Retention: All activities related to raw material inventory
control are documented, including:
○ Receiving reports.
 ○ Material quarantine records.
○ Inventory control logs.
○ Stock issuance records.
○ Inventory reconciliation reports.
➢ Management Review: Inventory control procedures are periodically reviewed and
updated to ensure effectiveness and compliance with regulatory requirements.
● Finished Product Inventory Control: This defines procedures for tracking finished
product inventory, including storage conditions, expiration dates, and batch tracking.
➢ Finished Product Labeling and Packaging:
○ Each finished product unit receives a unique identifier (lot number, serial
number) for traceability purposes.
○ Labels adhere to regulatory requirements and include essential
information like product name, dosage form, expiry date, and batch
number.
➢ Finished Product Quarantine:
0 Upon completion of packaging, finished products may undergo final
inspections and testing to ensure they meet all quality specifications
before release.
➢ Storage and Warehousing:
0 Finished products are stored under controlled conditions according to
their specific requirements (e.g., temperature, humidity).
○ A dedicated warehouse management system tracks quantities, expiry
dates, lot/batch numbers, and storage locations for complete
traceability.
➢ Inventory Management:
0 Inventory levels are monitored to prevent stockouts and ensure optimal
storage utilization.
○ A FIFO (First-In-First-Out) method is often used to prioritize the
distribution of older batches first.
➢ Order Picking and Shipping:
0 A documented picking and shipping process ensures accurate selection
and dispatch of finished products based on customer orders.
○ The picking process is recorded in the warehouse management system,
updating inventory levels.
○ Shipping documents accompany the products, including lot/batch
numbers and expiry dates for traceability.
➢ Batch Tracking and Recall Management:
0 A robust batch tracking system allows for tracing a specific batch
throughout the supply chain, from raw materials to finished products
distributed to customers.
○ This facilitates targeted recalls if necessary, minimizing risks associated
with defective products.
 ➢ Expiration Date Monitoring and Management:
0 Inventory management systems generate alerts for approaching expiry
dates.
○ Procedures are established for handling near-expired products, such as
offering discounts, donating to charities, or safe disposal.
➢ Documentation and Retention: All activities related to finished product
inventory control are documented, including:
0 Production records.
○ Finished product labeling information.
○ Warehouse storage logs.
○ Inventory control records.
○ Picking and shipping documents.
○ Batch tracking records.
○ Expiry date monitoring reports.
➢ Management Review: Finished product inventory control procedures are
periodically reviewed and updated to ensure effectiveness and compliance
with regulatory requirements.
● Waste Management Procedures: This outlines the proper handling and disposal of
hazardous waste generated during the manufacturing process.
➢ Waste Segregation: Establish a system to segregate different waste streams at
the point of generation. Common categories include:
○ Expired or unused pharmaceuticals.
○ Contaminated solvents and reagents.
○ Chemical residues.
○ Contaminated packaging materials.
○ Non-hazardous solid waste.
➢ Waste Characterization:
○ Each waste stream is characterized to determine its hazards and disposal
requirements.
○ This often involves testing to identify its flammability, toxicity,
corrosivity, and reactivity properties.
➢ Waste Labeling and Storage:All waste containers are clearly labeled with:
○ Type of waste.
○ Hazards associated.
○ Accumulation start date.
➢ Documentation: Maintain comprehensive waste management records,
including:
○ Waste characterization data.
○ Inventory of accumulated waste.
○ Manifests for waste transport.
○ Disposal certificates.
 ➢ Waste Disposal: Partner with a licensed hazardous waste disposal company to
ensure proper treatment and disposal based on waste characteristics and
regulations.
➢ Employee Training: Regularly train personnel involved in waste handling
procedures on:
○ Waste segregation and characterization.
○ Safe handling practices (PPE usage).
○ Emergency response procedures.
○ Regulatory requirements.
➢ Waste Minimization: Continuously explore waste minimization strategies:
○ Process optimization to reduce waste generation.
○ Reuse or recycling of materials where possible.
○ Utilizing less hazardous alternative materials.
➢ Management Review: Regularly review and update waste management
procedures to ensure compliance with regulations and identify opportunities
for improvement.

4. Service Delivery Procedures:

● Contract Review and Approval Processes: This outlines the steps for reviewing and
approving new service contracts with clients. It ensures all requirements and
specifications are clearly defined.
➢ Initiation and Contract Negotiation:
0 A manufacturing and quality control department initiates the need for
a service contract with a potential vendor.
○ Negotiations between the company and vendor establish the scope of
services, pricing, timelines, and other key terms.
➢ Internal Review: The initial draft contract is reviewed by a designated internal
team, typically including:
0 Legal department: Ensures legal compliance and protects company
interests.
○ Quality Assurance (QA): Evaluates the vendor's quality management
system and ability to meet GMP requirements.
○ Procurement or contracting department: Reviews pricing, payment
terms, and overall contract structure.
○ Engineering department to assess technical specifications and
feasibility.
➢ Revision and Redrafting:
0 The contracting department (or designated lead) revises the contract
based on the internal review team's feedback.
○ Any revisions are communicated to the vendor for their agreement.
➢ Final Review and Approval: The final contract goes through a final review by
senior management, often including:
 0 Head of the department requesting the service.
○ Legal department for final approval on legal soundness.
➢ Contract Execution: Authorized representatives from both the pharmaceutical
company and the vendor formally sign the contract.
➢ Contract Management: A department that would maintain a record of the
contract and monitor its performance throughout the service agreement.
● Project Management Procedures: This outlines the framework for managing service
projects, including project planning, resource allocation, communication protocols,
and milestone tracking.
➢ Project Initiation: Identify a need for a service project, such as:
○ Implementing a new quality control system.
○ Upgrading manufacturing equipment.
○ Validating a new cleaning process.
➢ Project Planning: Develop a detailed project plan outlining:
○ Work Breakdown Structure (WBS): Breaks down the project into
manageable tasks and subtasks.
○ Schedule: Defines the timeline for each task, considering dependencies
between tasks and resource availability. (Gantt chart or critical path
method can be used)
○ Budget: Estimates the costs associated with labor, materials, and other
project resources.
○ Resource Allocation: Assigns qualified personnel to specific tasks
based on their expertise and availability.
○ Communication Plan: Defines communication protocols for
information sharing between project team members, stakeholders, and
clients.
(Meetings, reports, dashboards)
○ Risk Management Plan: Identifies potential risks and establishes
mitigation strategies to minimize their impact.
➢ Project Execution:
○ Implement the project plan, monitoring progress against the defined
schedule and budget.
○ Conduct regular project team meetings to discuss progress, address any
issues, and ensure clear communication.
○ Utilize project management tools such as software or spreadsheets to
track tasks, deadlines, and resource allocation.
➢ Quality Management:
○ Integrate Quality Management (QM) principles throughout the project
lifecycle to ensure deliverables meet all regulatory requirements and
client specifications.
○ Conduct regular audits and inspections to identify and address any
quality deviations.
 ○ Maintain detailed documentation of all project activities and quality
control measures.
➢ Change Management:
○ Anticipate and manage project scope changes through a defined change
control process.
○ Document all changes, obtain necessary approvals, and update the
project plan accordingly to minimize disruptions.
➢ Milestone Tracking and Reporting:
○ Track progress against predefined milestones established during project
planning.
○ Generate regular progress reports for project stakeholders and clients,
keeping them informed of achievements and potential challenges.

➢ Project Closure:
○ Upon project completion, conduct a final review to assess the project's
success against its objectives.
○ Document lessons learned to improve future project execution.
○ Formally close the project and release assigned resources.
● Change Order Management Procedures: This defines the process for handling
changes to service requests after the initial contract is signed
➢ Initiation of Change Request:
○ The client or project team member identifies a need for a change to the
project scope, timeline, or budget.
○ A formal Change Request Form is submitted, clearly outlining the
proposed change, its rationale, and potential impact on the project.
➢ Evaluation and Review: The project manager evaluates the change request
considering factors like:
○ Feasibility and technical implications.
○ Impact on schedule, budget, and resource allocation.
○ Potential quality or regulatory compliance risks.
➢ Negotiation and Pricing: If the change is deemed feasible, negotiations take
place between the client and service provider to determine the impact on:
○ Project scope and deliverables.
○ Timeline and completion date.
○ Costs associated with implementing the change.
➢ Change Order Approval:
○ Once an agreement is reached, a formal Change Order document is
prepared, outlining the details of the approved change, its impact, and
the revised project plan (schedule, budget).
○ The Change Order requires approval from authorized representatives of
both the client and service provider.
➢ Implementation and Documentation:
 ○ The approved change is implemented according to the revised project
plan.
○ All documentation related to the change request, evaluation, negotiation,
and final Change Order is maintained for audit purposes.
➢ Project Update and Communication:
○ The project plan, including schedule, budget, and resource allocation, is
updated to reflect the approved change.
○ All relevant project stakeholders are informed about the approved
change and its implications.
➢ Version Control: Maintain clear version control of the project plan and other
documents to reflect the latest approved changes.

5. Document Management Procedures: This ensures all company documents,

including COPs themselves, are properly controlled, reviewed, and updated.

➢ Document Creation and Approval:

0 Documents are created by qualified personnel following predefined
templates that ensure consistency and meet regulatory requirements.
○ An approval process is established, involving relevant subject matter
experts and management, to review and approve the document before
implementation.
➢ Document Control and Versioning:
0 A centralized document management system (electronic or paper-
based) tracks all document versions.
○ Each document has a unique identifier and a clear revision history to
identify the latest approved version.
➢ Document Distribution:
0 The latest approved versions of documents are distributed to relevant
personnel in a controlled manner.
○ Distribution records are maintained to ensure all necessary parties have
access to the current procedures.
➢ Document Review and Update:Documents are periodically reviewed based on
a predefined schedule or triggered by events like:
0 Changes in regulations.
○ New equipment or processes.
○ Deviations or non-conformances.
○ Feedback from personnel.
➢ Training:
0 Personnel are trained on the document management system and their
roles and responsibilities related to document access, usage, and
reporting any discrepancies.
○ Training is provided on specific SOPs relevant to their job functions.
 ➢ Document Retention:
0 Documents are retained according to regulatory requirements and
company policies.
○ A retention schedule defines the duration for which different types of
documents need to be archived.
➢ Auditing:
0 Document management procedures are regularly audited to ensure
compliance with regulatory requirements and effectiveness in
maintaining accurate and up-to-date documentation.

6. Employee Training Procedures: This outlines the training requirements for

employees on various procedures and GMP (Good Manufacturing Practice) principles.

➢ Needs Assessment: Identify training needs for different employee groups

based on:
0 Job roles and responsibilities.
○ Prior experience and qualifications.
○ Regulatory requirements and Good Manufacturing Practices (GMP)
principles.
○ Company policies and procedures (including SOPs).
○ Skills gaps identified through performance reviews or audits.
➢ Training Program Development: Develop training programs tailored to
specific needs, covering topics like:
0 GMP principles (e.g., aseptic techniques, record-keeping, quality
control).
○ Specific job skills and procedures (e.g., operating equipment, cleaning
protocols, data analysis).
○ Emergency preparedness and response procedures.
○ Safety protocols and hazard awareness.
○ Ethics and data integrity principles.
➢ Trainer Selection and Qualification:
0 Select qualified trainers with subject matter expertise, communication
skills, and training experience.
○ Trainers should be up-to-date on the latest regulations, technologies, and
best practices in their respective areas.
➢ Training Delivery and Documentation: Schedule training sessions considering
work schedules and avoiding disruptions to production.Maintain training
records including:
0 Training program content and objectives.
○ Attendance records.
○ Trainer qualifications.
○ Assessment results
 ➢ Evaluation and Feedback: Evaluate the effectiveness of training programs
through methods like:
0 Pre- and post-training assessments.
○ Feedback surveys from participants.
○ Observation of job performance.
➢ Ongoing Training and Refresher Courses: Provide ongoing training
opportunities to keep employees updated on:
0 Changes in regulations and best practices.
○ New equipment or technologies.
○ Company policy updates.
➢ Documentation Retention: Maintain training records according to regulatory
requirements and company policies.

19. REWARDS AND MOTIVATION FOR PERSONNEL

Personnel are compensated and rewarded through:

● Recognition: By recognizing the outstanding work of the employee, it will
boost their confidence in achieving more.
● Cash Incentives: Cash incentives are a good reward to help sustain the daily
expenses of the employee or to indulge themselves in things they have or have
not experienced before.
● Day-off Voyage: After months of hard work, the employee deserves a relaxing
break to unwind and breathe to prepare for the next team project.
● Company Benefits: The employee will be provided benefits such as paid time
off, insurance, or retirement plans.

Activities that may motivate the personnel to be better at their job and to improve
retention of personnel:
● Team Building Activities: By connecting with the team and other colleagues, it
will serve as a foundation for building a good relationship and teamwork
among them; the employees may also develop feelings of comfort and
belonging to their colleagues, which would make them feel at ease and
motivated at work.
● Recognition and Positive Feedback: Recognizing and giving positive feedback
to an employee is a huge confidence booster, which motivates the employee to
continue giving their best out of every task.
● Assign Leadership Roles: Assigning leadership roles to an employee will
allow their team to strive to reach their goals and develop competency.
● Show Interest in Their Work: Showing interest in an employee’s work shows
them that they are heard and makes them feel like they are doing their tasks
right.
 Timeline:
● Monthly Evaluation: During the monthly evaluation, the manager will assess
who among the employees performed the best job and accomplished the tasks
on time and decide which reward the manager will be giving.
● Annual Overall Evaluation: The employee’s work will be evaluated at year-
end, and the manager will decide who performed best overall for the full year.

20. PERFORMANCE EVALUATION PERSONNEL

This section focuses on the methods employed to assess and guide the performance of
personnel.

● Performance Appraisal:
Our organization leverages a well-defined performance appraisal system to assess each employee's
contributions in relation to pre-established objectives and key performance indicators (KPIs). These
appraisals involve reviewing achievements, strengths, and areas for improvement, and setting goals for
the next evaluation period.
Annual performance appraisals are carried out to formally assess employees' performance during the previous
year.

● Regular Performance Feedback:

The supervisors provide constructive feedback and also include peer feedback
sessions, or anonymous employee surveys to gauge satisfaction and identify areas for
improvement. This feedback should be specific, actionable, and delivered in a
supportive manner.

● Self-Evaluation:
Employees are required to complete self-evaluation forms in order to thoroughly assess their
performance, accomplishments, and areas for development. This self-assessment process allows
individuals to identify personal goals and determine areas where they may require guidance from
their supervisors.

● Recognition and rewards:

Outstanding performance is acknowledged and rewarded to motivate employees and
reinforce desired behaviors. Rewards may include bonuses, promotions, or other forms of
recognition within the organization.

Timeline:
1. Regular Performance Feedback - Monthly - Quarterly
2. Self-Evaluation - This can be completed around the same time as the mid-cycle review
to inform discussions with supervisors.
3. Performance Appraisal - Annually
4. Recognition and Rewards - Ongoing