Pharmaceutical Manufacturing is the synthesis and manufacture of medicines on an industrial scale in a pharmaceutical

manufacturing plant.

Here is a quick overview of the departments typically found within a (bio) pharmaceutical factory:

% of Company
Department Includes…
Employment

Production Upstream & Downstream activities, Manufacturing,

50%
(Manufacturing) Science & Technology (MSAT), Fill Finish/Packaging

Quality (including Quality Assurance, Quality Control, Validation,

30%
Validation) Regulatory Affairs

Operations 10% Technical Services, IT Automation & Control

Research & Varies depending on products and areas targeting for

0-5%
Development product improvement

Supply Chain, Logistics, Marketing, HR, Warehouse,

Other 10%
Finance, etc.

BTW, if you are interested in a new career in pharma or want to upskill for a promotion, check out our pharmaceutical
courses.
Production (Manufacturing)
Deal with all stages of pharmaceutical product manufacture – from producing active ingredients, through to completion of
finished products and even packaging. Due to this diversity, work in this area can take many forms and involve the use of
specialist machinery. These production processes are all carried out in strict adherence to both internal and external
protocols.

Typical % of total company employment: 50%

Breakdown of department activities in Biopharmaceutical manufacturing:
Upstream & Downstream activities

 Upstream activities – are stages of biopharmaceutical processing up to the cell culture or fermentation process
that is used to make the target proteins.
 Downstream activities – are the stages of processing that come after cell culture or fermentation. These stages
include separation and purification to achieve the required drug product
 Averages 30% of total company employment (in a new plant the number will start low and increase as activities
are scaled up through to full production)
 Generally engineers, scientists and technicians with Honours Degree and Masters level qualifications

Manufacturing, Science & Technology (MSAT)

 Supports operations with activities such as continuous process improvement, implementing new technologies
and troubleshooting.
 Average 10% of total company employment.
 Typically engineers, scientists and technicians with Ordinary Degree and Honours Degree level qualifications
Fill Finish/Packaging

 Some of the final stages of the manufacturing process where the active agent is prepared into its final form,
before being filled and sealed within containers.
 Average 10% of total company employment once at full production.
 Usually requiring Ordinary or Honours Degree level qualifications but some Diploma level qualifications with
relevant experience may be suitable

Skills needed include:

 Good manufacturing practice

 Aseptic and sterile manufacturing
 Upstream processing
 Cell culture
 Downstream processing
 Drug substance production
 Media and buffer preparation
 Viral clearance
 Lean Six Sigma manufacturing

Quality (including Validation)

The functional area that monitors and documents activities, processes and products of manufacturing to ensure they meet
strict standards and predefined expectations. Ultimately, this team ensures the safety of the drugs that go out for
distribution – their activities are essential within such a regulated industry.

Typical % of total company employment: 30%

Breakdown of department activities includes:

 Quality Assurance – focuses on eliminating process variation by creating, revising and strictly implementing a set
of tightly and precisely defined process/procedures/checklists/quality system standards that when exactly
followed, ensure the final quality of the product. Quality Assurance is preventative by nature and makes sure you
are doing it “Right First Time”.
 Quality Control – is product-oriented and focuses on testing a sample of the final product of a manufacturing
process to make sure that is meets the required design specifications or quality standards. Testing for quality can
be done with a 100% sampling or with a small sample using techniques like statistical process control (SPC).
 Validation – creates an evidence trail to show a process or system leads to a consistent result that can be
reproduced
 Regulatory Affairs – deal with the applications and paperwork surrounding regulations that have to be done
before a medicine can be sold to the public

Skills needed include:

 Good lab practice

 Molecular biology
 Protein characterisation
 Bioanalytics
 Biochemistry
 Protein chemistry
 Glycan analysis
 Microbiology
 Ultra performance liquid technology/ultra-high-performance liquid technology (UPLC/HPLC)
 Bioassays
 Mass spectrometry
 Documentation management
 Batch release
 Regulatory filings
Operations
Ensures the continuous functioning of the manufacturing plant and its equipment.

Typical % of total company employment: 10%

Breakdown of department activities includes:
Technical Services
Technical service covers areas such as maintaining the building infrastructure, facility management, equipment and
electrical maintenance, instrumentation and calibration, HVAC (heating, ventilation and air conditioning) to ensure a sterile
cleanroom atmosphere, providing clean utilities such as steam, water and compressed air.

 Average 6% of total company employment – numbers increase as plant scales up to full production
 Generally, workers will have a minimum of an Ordinary Degree level qualification alongside relevant experience.
Employees with a Diploma level craft qualification may be suitable for upskilling

Automation & Control/IT

Covers areas such as information technology, multiple system integration, using automation and control, e.g. installing,
programming and maintaining Program Logic Controllers (PLCs) – these are special-purpose computers used to control
industrial manufacture processes to oversee or manage the manufacturing process and streamline it to make it as efficient
as possible.

 Average 4% of total company employment during full production

 For roles here, typically an Ordinary Degree level qualification is required

Skills needed include:

 Facility management
 Equipment maintenance
 Clean utilities
 Calibration
 Automation

Research & Development

Where staff are engaged in making improvements and modifications to existing production processes and identifying
possible new production technologies and applications.

Typical % of total company employment: 5%

Department requirements:

 May be located within the facility or at a centralised company location

 Typically requires a minimum of Honours Degree qualification alongside experience
 Averages 30% of total company employment (in a new plant the number will start low and increase as activities
are scaled up through to full production)

Skills needed include:

 Varies depending on products and areas targeting product improvement

Other
Includes areas such as Supply Chain, Logistics, Marketing, HR, Warehouse, Finance, etc.

Typical % of total company employment: 10%

Breakdown of department activities includes:

 May be located within the facility or at a centralised company location

 Typically requires Ordinary or Honours Degree level qualification with domain-specific knowledge. Warehouse
roles may be suitable for those with Diploma qualifications and appropriate upskilling
Skills needed include:

 Good distribution practice

 Project management
 Production planning
 Procurement
 Stock management
 Distribution
 Warehousing

One thing to keep in mind is that this is just a guide. The size of these departments ultimately depend upon the size of the
pharmaceutical company (smaller companies may outsource some of these roles altogether), but they are all ultimately
critical parts of the pharmaceutical manufacturing process.

 Basic Structure and Departments in our company

Nowadays, there are thousands of pharmaceutical companies out there. You will be surprised when trying to Google how
many registered pharmaceutical companies.

As of 2022, there are over 2000 brand name pharmaceutical manufacturing businesses in the US alone [1]. In Europe, the
total number of pharmaceutical companies is over 308000 [2].

The majority of these companies are start-ups and considered small, not to mention the struggle they go through in order
to be a successful business entity. There are many factors to support the success of a company, such as fund, management,
culture, vision, and many others. In this article, we will look at the aspect of basic organization structure within the
company.

(Bio)Pharmaceutical companies are essentially manufacturing companies. The main goal is to manufacture medicines on an
industrial scale in a pharmaceutical manufacturing plant.

Below is a quick overview of the departments that are typically found within the company:

 Production (Manufacturing)
 Quality
 Operations
 Research and Development
 Other

Production (Manufacturing)

As mentioned above, pharmaceutical companies are essentially manufacturing companies. So, Production would have the
highest portion of employment within the company. A typical percentage of total company employment is between 30%
and 50% depending on the stage of the company.

The Production (Manufacturing) department deals with all stages of pharmaceutical product manufacture, from producing
active ingredients through the completion of finished products (packaging).

The following is the breakdown of department activities:

Upstream activities

Upstream activities are the early stages of biopharmaceutical processing from cell bank until the cell culture process. There
are certain target proteins as the output of the cell culture process.

Downstream activities
Downstream activities are the stages that include separation and purification to achieve the required drug substance.

Fill Finish / Packaging

This is the final stages of the manufacturing process when the active product is prepared to its final form, then being filled,
and sealed within specific primary and secondary containers. Aseptic techniques and detailed labeling play critical roles in
these activities.

Quality

Quality is the function within the company that monitors all production-related activities, ensuring that they meet
standards and predefined expectations. Depending on the stage of the company, the quality unit can be up to 30% of total
company employment.

The following is the breakdown of department activities:

Quality Assurance

This is the main function where the focus is to maintain predefined process standards and expectations. The main mindset
that is sometimes missed is that quality assurance is supposed to be preventative by nature (“Right the First Time”),
instead of corrective. Most of the time we got caught up in corrective mindset due to high number of errors.

Quality Control

It is the function within biopharmaceutical company where the focus is on ensuring the products are produced as designed
by testing product samples and ensuring proper monitoring of the production area and utilities.

Validation

Some companies have Validation function separated from Quality. Validation is one of the key functions, especially in the
early stage of the company, as this function creates an evidence trail showing a process and system that leads to a
consistent result that can be reproduced throughout the life of the company.

Regulatory Affairs

This function deals with all the matters related to outside regulations that must be complied with before the company can
sell their medicine to the public.

Operations

Operations ensure the production continuous functions as expected, including the process, plant, and equipment/system.
A typical percentage of total company employment is between 5% and 15%.

The following is the breakdown of the Operations activities:

Manufacturing, Science, and Technology (MSAT)

This group supports activities on the process side such as continuous process improvement, implementing new
technologies, and troubleshooting.

Engineering / Maintenance / Automation / IT

Maintaining building and facilities physical infrastructure is an important aspect for successful production. Production
equipment needs to be maintained and calibrated periodically, and HVAC system needs to be maintained to ensure a good
cleanroom condition.

Research and Development

Depending on the stage, the R&D department can play a critical role within the company. Many small size (start-up)
companies still focus on developing products rather than producing on a large scale. For these companies, the percentage
of total employment can be significantly higher than the large companies that already produce products on a large
commercial scale.

Other

This category includes areas such as Supply Chain, Marketing, HR, Finance, etc.

Steps to Start a HR Team

Step 1 – To maintain all employee records (excel format)

Step 2 – To maintain each employee’s personnel file (scanned copies & hard copies)

Step 3 - Defining Organisation structure with departmental and individual’s job responsibilities

Step 4 - Recruitment and selection process

Step 5 - Leave management system (Create policy & implement)

Step 6 - Training and development (Training needs, Training calendar and Organize trainings)

Step 7 - Employee grievance handling & Employee engagement

Step 8 - Performance Appraisal System (Create policy & implement)

Step 9 - Employee hand book ( It will contain company’s policies, norms, regulations and general conduct
within an Organization)

Step 10 - Future Strategies for achieving company and individualistic goals

Have to take part in:

I should develop and impart

Soft skills training (Communication, Listening, Writing skills, Manners & Etiquette, Presentation skills, Interview &
Supervisory skills and so on...),

Behavioural topics (Teamwork, Problems Solving, Conflict Resolution, Culture Building, Interpersonal ability, Personal
Effectiveness and so on)

Management skills (Time Management, Delegation, Change Management, Creative & Critical thinking and so on)
 1. 'Recruitment till Retirement' HR stages in detail.
2. Train Owners / Seniors and Junior HR officials in HR functions
3. Job Profile designing & KRAs / KPIs of the positions
4. Performance Management (Appraisals) - complete framework, implementation and training
5. Practical Employee Engagement
6. Design and Draft HR Booklets
7. Coaching on Personality Development topics
9. Motivational Lectures on Work Ethics, Team Spirit and Code of Conduct for Blue Collared employees
10. HR Adviser for company to redefine / reset / re-align the HR function

Organizational Chart with Responsibilities

Project Management Team chart

Factories organisational chart

Effective Pharmaceutical Management: Core Principles and Strategies

Pharmaceutical management plays a crucial role in ensuring the success and sustainability of pharmaceutical
companies. It involves the effective planning, organizing, and controlling of pharmaceutical activities to achieve
organizational goals. This article explores the core principles and strategies of effective pharmaceutical
management, highlighting key aspects such as leadership, regulatory compliance, supply chain management,
and innovation.

Leadership in Pharmaceutical Management

Effective leadership is essential for successful pharmaceutical management. Leaders in this field must possess
strong interpersonal skills, strategic thinking abilities, and a deep understanding of the pharmaceutical
industry. They should inspire and motivate teams to achieve organizational objectives while maintaining high
ethical standards and compliance with regulations.

Regulatory Compliance

Pharmaceutical companies operate in a highly regulated environment, requiring strict adherence to regulatory
requirements. Effective pharmaceutical management involves ensuring compliance with regulations related to
drug development, manufacturing, distribution, and marketing. This includes obtaining necessary approvals,
maintaining quality standards, and monitoring and reporting adverse events.

Supply Chain Management

Efficient supply chain management is critical in the pharmaceutical industry to ensure the timely delivery of
high-quality products to customers. This involves managing the flow of materials, information, and finances
from suppliers to manufacturers to wholesalers to retailers and finally to customers. Pharmaceutical
companies must adopt innovative supply chain practices to reduce costs, improve efficiency, and enhance
customer satisfaction.

Innovation in Pharmaceutical Management

Innovation is key to staying competitive in the pharmaceutical industry. Effective pharmaceutical management
involves fostering a culture of innovation within the organization, encouraging employees to generate new
ideas and solutions. This can lead to the development of new drugs, improved manufacturing processes, and
enhanced marketing strategies.
Conclusion

Effective pharmaceutical management is essential for the success of pharmaceutical companies. By following
core principles such as effective leadership, regulatory compliance, supply chain management, and innovation,
pharmaceutical companies can achieve their goals and contribute to the advancement of healthcare
worldwide.

References:

1. Gupta, R. K. (2019). Pharmaceutical Management: Principles and Practice. New Delhi: Jaypee Brothers
Medical Publishers.

2. Lyles, A. (2018). Pharmaceutical Management: Concepts, Strategies, and Tools. New York: Business Expert
Press.

3. Shargel, L., Yu, A. B. C., & Wu-Pong, S. (2012). Applied Biopharmaceutics & Pharmacokinetics (7th ed.). New
York: McGraw-Hill Medical.

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer
and consumer. Imagine facing a Class 2 recall after your product ships!

In 2010, Johnson and Johnson found itself battling a firestorm after the FDA recommended a Class 2 recall of millions of
bottles of OTC infant's pain relievers due to manufacturing quality problems.

The headaches didn't end in 2010. Five years later, the company was still battling the FDA over how the recall was
conducted. Six years later, lawyers were still offering free consultations to affected families.

Understanding the objectives of quality assurance and its benefits can help your company to put appropriate emphasis on
and allocate sufficient resources to this crucial component of your business.

5 Objectives of Quality Assurance in the Pharmaceutical Industry

Do you want to know the foundational principle that separates every industry-leading pharmaceutical company from the
rest? It's that quality is an investment which leads to competitive advantage rather than an expense which is required to
maintain regulatory compliance.

Look at how Medtronic, one of the leading life sciences companies in the world, approaches quality:

We manufacture safe, high-quality products not only to further our Mission, but also to build trust, reduce reputational risk,
and improve operational efficiency."

So, certainly, there are other benefits to quality assurance in the pharmaceutical beyond just staying on the good side of
regulatory bodies. Here are five of the most prominent.

1. Protect the Public

Your number one goal is — and always should be — to protect the public. You are creating medications that can literally
change someone's life for the better.
Conversely, if your quality standards aren't where they should be, those same life-changing products can cause irrevocable
harm and even death. Your customer's safety is paramount and should never be taken for granted as you seek to grow
your company and make a profit for your investors.

As you implement a pharmaceutical quality assurance plan, keep the end-user at the forefront of the minds of all team
members.

How to Achieve this Objective:

You must implement strict quality control processes that include:

 Document control

 Employee training

 Deviation

 Laboratory OOS (Out of Spec)

 Corrective and Preventive Action (CAPA)

 Internal Audits

 Management Review

2. Inspire Professional and Consumer Confidence

According to Edelman's 2018 Trust Barometer, pharma remains the least-trusted healthcare sector at 55% globally. You
also suffer from being the most frequently blamed by survey respondents for the high cost of care.

There is definitely a crisis of public trust at play right now. The People vs Big Pharma does a great job of explaining all of the
underlying confidence issues that exist in the pharmaceutical industry.

The pharma sector's noble goals of saving lives and curing diseases are often buried under the latest news about high drug
prices, opioid scandals, and anti-competitive behaviors. So what can you do?

How to Achieve this Objective:

You are unfortunately participating in one of the flagship global issues of the 21st century. Consumers want fair access to
affordable and life-saving new treatments, so rebuilding trust with prescribing professionals and inspiring consumer
confidence isn't going to happen overnight.

There are a few steps you can take to start moving things in the right direction. Most of them involve bringing the human
side back into your industry.

 Learn from Pharmaceutical Research and Manufacturers of America's (PhRMA) GoBoldly initiative and talk about

the innovations and hard work that goes into creating life-changing medications.

 According to David Mitchell, president and founder of the US-based campaign group Patients for Affordable

Drugs, "... do something that's real." He calls for pharma groups to open communications and take a more

proactive role in discussions to reform drug pricing.

3. Safeguard Against Negative Publicity

Swaying public opinion and making them fall in love with the pharma industry may not happen quickly, but there are steps
you can take to avoid being the latest scandal.
There are lawyers that literally make their living building up class-action lawsuits against drug manufacturers that fail
quality standards.

Some bad interactions are unavoidable. Consumers will take the medication in a way not originally intended, it will interact
with something else they are taking, or there will be some other unexpected side effect that didn't occur in your clinical
trials.

However, there are things that you can anticipate and impact.

How to Achieve this Objective:

You can control the quality of pharmaceuticals that you produce, the literature that you provide to physicians, and your
response to complaints.

 Invest in an Enterprise Quality Management System (eQMS) that can help you track quality across your entire

supply, production, and distribution chain.

 Establish a Corrective and Preventive Action (CAPA) system to support self-correcting quality systems within your

organization and assure that quality issues are resolved.

https://www.getreskilled.com/pharmaceutical-companies/regulations/ - Pharmaceutical regulations