PURPOSE

• To enhance the poor hygiene and have high expectations to all newly employed.

• Promote consistency and steadiness to all the employees.

• Eliminate manufacturer errors in pharmaceutical company.

• Elevate the status of all the employees and pharmacists to enhance their motivation for a better
performance.

SCOPE

This SOP covers the contamination in producing vitamin c + zinc syrup that was discovered that a specific
batch has a high level of Escherichia coli due to the poor hygiene of the new employees.

RESPONSIBILITIES

The personnel involved in Manufacturing and Quality Control is responsible to follow all the guidelines
and policies in this Standard Operating Procedure (SOP) to ensure the safety and quality of the products,
especially to avoid errors and contaminations.

The Supervisor also is responsible in ensuring that all employees and personnel are observing and
compliance to the SOP for their safety during production.

GENERAL

This set of Standard Operating Procedure (SOP) contains the specified guidelines and policies in ensuring
safety, efficacy and quality of the production of Vitamin C+Zinc. Procedures that personnel need to
comply for their safety during production. This SOP aims to avoid error and contamination that takes
danger to both employees and to the production itself.

DEFINITION

GMP – Good Manufacturing Practice is a quality assurance system that ensures items are
consistently produced and controlled to meet quality requirements. It's intended to reduce any
risks associated with pharmaceutical production that can't be avoided by testing the finished
product.

Hygiene - is a series of practices performed to preserve health. According to the World Health
Organization, "Hygiene refers to conditions and practices that help to maintain health and
prevent the spread of diseases."

Standard Operating Procedure - A Standard Operating Procedure (SOP) is a document that

specifies the processes that occur on a regular basis and are important to the investigation's
quality. The goal of a SOP is to ensure that operations are carried out correctly and consistently.
Contamination - the act of making anything filthy or poisoned, or the state of having unwanted
or harmful chemicals contained in one's possession.

PROCEDURE

Procedure Grooming: 

1. Come to work with clean hair, cleaned teeth, and a daily wash.

2. Fingernails should be clipped, filed, and cleansed to avoid rough edges. In the
manufacturing area, polished fingernails and fake nails are not authorized. A daily check will be
carried out and documented.

3. Before entering the processing area, employees in the production area must wash their
hands thoroughly, and gloves must be worn as needed. Hands must be cleansed at all times:
Before commencing work.

 Wear disposable gloves first.

 While completing various tasks.
 Return to work station immediately after using the restroom.
 After touching a contaminated object or doing an unclean duty - such as taking out the trash,
handling cleaning chemicals, wiping tables, picking up fallen cutlery, and so on.
 After a cigarette, a meal, or a drink.
 Following contact with the face, nose, mouth, skin, hair, or other exposed bodily areas.
 After sneezing, coughing, or blowing your nose.

4. Wash your hands exclusively in sinks that are meant for this purpose. To avoid
recontamination of clean hands, turn off faucets in a hygienic manner.

5. Using single-use towels, dry hands and discard dirty towels in a closed trash container.

Proper Attire: 
 1. At all times in the manufacturing area, wear clean, properly secured coveralls, hair
restraints, and gloves. All personal clothes must be covered with coveralls. They will be
modified daily.

2. Coveralls must not be worn outside of the production area. Before visiting the restroom,
lunchroom, or departing the manufacturing area, remove your coveralls, hair restraints, and
gloves.

3. At all times in the manufacturing area, use hair restrictions. To avoid any contamination
of health supplement goods, all hair must be covered.

4. Beard nets are required for employees with facial hair (beards or mustaches).

5. Switch to clean, non-slip, closed-toe work shoes that are suitable for standing and working
on factory floors. Before visiting the restroom, eating lunch, or leaving the manufacturing area,
work shoes must be removed. Footwear must be easy to clean and retain a clean appearance.

6. When entering the manufacturing area, remove your make-up, wristwatch, and jewelry.

7. Proper clothes will be verified and recorded daily.

8. Personal possessions and clothing should be stored in a dedicated locker facility. This
locker facility does not allow the storage of food, beverages, tobacco products, or personalized
medicine.

Illness and lesion:

 1. Employees must not be carriers of or diagnosed with the following communicable
illnesses: tuberculosis, cholera, typhoid fever, chickenpox, dysentery, measles, mumps, leprosy,
jaundice, red-eye, lymphatic filariasis, hepatitis, or infectious skin disorders. Employees with
certain disorders should not be permitted to work in manufacturing plants, and the local health
regulatory body should be informed.

2. Report any flu-like symptoms to the supervisor, including fever, diarrhea, sore throat,
persistent sneezing, coughing, runny nose, and/or vomiting.

Employees who exhibit these symptoms will be sent home, reassigned to non-food-related
responsibilities, or given sick leave, as necessary.

3. Inform your supervisor if you see any lesions on your hand, wrist, or any other exposed
body area.

4. Minor cuts and abrasions can be treated and wrapped correctly. When working with
bandaged hands, disposable gloves must be worn to cover the whole bandaged region.

5. Until their health improves, employees with major lesions should not be permitted to
handle raw materials, packaging materials, in-process materials, or final goods.

Smoking, eating, and gum chewing: 

1. Only smoke in designated locations. Inside production facilities, no smoking or chewing

of tobacco is permitted.

2. Only eat and drink in the specified places.

3. While working in the production area, avoid chewing gum or consuming confectionery.
 ATTACHMENT

Attachment 1: Employee Health and Personal Hygiene Practices -

https://tazewellhealth.org/DocumentCenter/View/168/2018-Personal-Hygiene-and-Employee-Illness-
Practices-PDF

Employee Health and

Personal Hygiene Practices
Did you know? According to the CDC, poor personal hygiene is considered the leading
cause of foodborne illnesses.

What are personal hygiene practices?

Personal hygiene practices are the overall behaviors, activities, and actions that can help food
employees from spreading viruses and bacteria to food. They can be summed up into four
categories:

1. Hand practices: employees shall follow proper handwashing procedures; avoid wearing
fingernail polish or false fingernails; use single-use gloves properly; and avoid bare hand
contact with ready-to-eat foods.
2. Personal cleanliness: food employees shall maintain an overall state of cleanliness,
including showering or bathing before work.
3. Work Attire: employees shall wear effective hair restraints, clean clothing and clean
aprons, and remove rings, bracelets, and watches before preparing food, washing
dishware, etc.
4. Employee illness policies: food employees are required to inform their manager or person-
incharge if they are experiencing vomiting and/ or diarrheal symptoms and are to be
excluded from the operation until symptom free for 48 hours or receive written release
from a doctor.

When should employees wash their hands?

Employees shall wash their hands immediately after engaging in activities that contaminate
the hands and...
 • When entering a food preparation area, or leaving and returning to a food prep area;
• Before putting on clean, single-use gloves for working with food and between glove
changes if a change in task has occurred;
• Before handling clean equipment and serving utensils, or after handling soiled dishes, equipment,
or utensils;

• When switching between handling raw and ready-to-eat foods;

• After touching the face, hair, or body, soiled clothing or aprons, or after coughing or
sneezing;
• After using the restroom, eating, drinking, smoking, using your cell phone, handling
money, taking out the garbage, sweeping/ mopping floors, using chemicals, after cleaning/
sanitizing, or any other activity that might contaminate the hands.

Why are good personal hygiene practices important?

Good hygienic practices can make the difference between serving food safe for consumption
and food that can make someone ill. Nearly 70% of food-borne illness can be traced back to
poor personal hygiene, whether as a result of an employee illness or handling foods with
bare hands. Accordingly, proper hand washing is a critical step in the food preparation process
to help prevent the spread of food-borne illnesses, such as the norovirus.

What are the proper handwashing steps?

1. Turn on the water and wet hands and arms using running water as hot
as is comfortable (at least 100°F).
2. Apply enough soap to build up a good lather.
3. Scrub hands and forearms for at least 20 seconds, paying particular
attention to the areas between fingers and underneath fingernails.
4. Rinse hands and arms thoroughly under warm, running water.
5. Dry hands and arms using single-use towels and use the disposable
towel to turn off the hand sink faucet.

Top 5 Most Common Personal Hygiene Violations:

1. Smart Watch Shenanigans — Remove jewelry from hands and arms before preparing food
or working around food prep areas because these items can harbor bacteria, fall off,
contaminate food, and prevent proper handwashing. Per the 2013 FDA Food Code, a plain
wedding band is the only acceptable form of jewelry.
2. Hand “un-washing” — After washing hands, ensure the faucet is turned off with a paper
towel, or other clean barrier, to prevent re-contaminating clean hands. Also consider using
a paper towel to open the door when leaving the restroom.
3. The ‘Ol Switcheroo — Dishwashers that handle dirty dishes and utensils must properly
wash hands before putting away clean and sanitized equipment to prevent cross-
contamination.
4. Employee Beverages —To prevent contaminating food and food-contact surfaces,
employees shall not eat in food preparation areas and are only permitted to drink from a
cup with a lid and straw.
5. Bare Hand Contact — Food can become contaminated when handled with bare hands,
particularly if hands have not been washed. Single use gloves, spatulas, tongs, or deli
tissues must be used as a barrier when handling ready-to-eat foods.

Attachment 2: Employee Hygiene Practices - https://www.gov.nl.ca/ffa/files/publications-pdf-employee-

hygiene.pdf
Attachment 3: Vishalidigitalagency. “Maintaining Hygiene in the Pharmaceutical Industry : A Glimpse of
Effective Practices to Implement - Lindström.” Lindström - India, 19 Oct. 2021

Maintaining Hygiene in the Pharmaceutical Industry: A Glimpse of Effective Practices to Implement

Proper hygiene is essential in the pharmaceutical industry to prevent any kind of contamination that can
affect the quality of medicinal products. When it comes to delivering highest quality standards of
pharmaceutical products, key hygiene factors need to be upheld. High levels of cleanliness and
sanitation must be practiced through all stages of manufacturing through a comprehensive screening –
from the personnel working in manufacturing plant to the production process.

Every pharmaceutical company should adhere to strict hygiene laws to ensure high-quality drugs are
manufactured and packaged in a contamination-free environment. Discussed here are the important
hygiene practices that a company should implement.

Production Hygiene

For your GMP-compliant production unit, it is crucial to follow tailored hygiene strategies to ensure safe
implementation and use of products in life science, biotechnology, cosmetic and medical applications.
To prevent contamination and maintain highest standards of sanitation, pharmaceutical manufacturing
companies must implement use of classical, sterile or microbial filtered disinfectants in addition to
manual disinfection process.

Innovative hydrogen peroxide vapour generators are streamlining the process of maintaining hygiene in
production facilities. These powerful machineries facilitate fast and effective decontamination of the
manufacturing unit and equipment.

The concept of clean room is also gaining remarkable popularity in the pharmaceutical industry. A
controlled environment is designed for specialised pharmaceutical manufacturing that maintains a low
level of airborne microbes, dust, chemical vapours and aerosol particles.

Significant product contamination may also occur at the time of loading or unloading the medicinal
products. Therefore, it is essential to check the premises carefully to identify dirty spots or breeding
zones, and clean the areas with disinfectants that are lab-tested and compliant with industry safety
standards.

Ensure all cleaning equipment meet key requirements of optimal ergonomics, sterilisation and clean
room requirements

The storage areas and walkways should be cemented to minimise the risk of spreading impurities

Following these basic hygiene practices will help maintain optimal sanitation standards in
pharmaceutical production plants and ensure the drug quality remains unaffected.

Personnel Hygiene

Despite effective measures taken to maintain hygiene for production facilities, equipment, raw materials
and product packaging, one of the primary sources of contamination are human beings. Having state-of-
the-art manufacturing unit or stringent Quality Control measures is not enough to ensure superior
hygiene in the pharmaceutical industry unless there are trained personnel to take the responsibility for
ensuring high standards of sanitation and product quality.

Educate and train all personnel working in the pharmaceutical sector regarding the importance of
hygiene

Implement use of hygienic workwear in specified work areas such as production facility, storage areas,
loading & unloading unit, etc. Proper training should also given regarding not using the hygiene clothing
when away from the manufacturing environment or using the canteen, smoking area and toilets

Such hygienic workwear should be available in sufficient numbers and must have a suitable design to
prevent product contamination. It should also include caps for scalp hair and snoods for moustaches and
beards

Laundering of workwear should be implemented only by an approved contractor or in-house facility

conforming to industry-defined criteria that validates the entire process. The following measures must
be undertaken to ensure highest standards of hygiene in workwear laundering:
Appropriate segregation of dirty and cleaned clothing

Effective cleaning of workwear following industry standards

Cleaned clothing must be supplied in contamination-free bags or covers

Proper verification and validation of the laundry process should be in place and practiced thoroughly

Implement use of high-performance hand disinfectants and dispensing systems to meet the highest
standards of hand hygiene – one of the most critical preventive measures to avert the risk of germ &
impurity transmission by the hands of the personnel.

The use of proper and hygienic workwear is crucial to maintain high standards of pharmaceutical safety
and ensure wellbeing of the end consumers. At the same time, effective measures must be taken to
facilitate high quality cleaning, sterilisation and delivery of workwear to uphold hygiene at the
workplace. Proper training should also go to every employee regarding maintaining efficient personnel
hygiene.

Plant and Surface Disinfection

In addition to practicing effective production hygiene, proper measures should also be taken to disinfect
the plant and surface.

Use high-quality, industry-approved sterilisation products that are tested for efficacy,

user friendliness and occupational safety

Ensure the plant walls, ceilings and floors are washable; regular cleaning and scrubbing

is important to avoid impurity accumulation and spreading contaminants

Ensuring Pharmaceutical Hygiene through Performance Monitoring

When it comes to complying with the hygiene standards suitable for the pharmaceutical industry,
effective monitoring holds immense significance. Merely implementing hygiene strategies is not enough;
it is crucial to monitor performance of the measures taken in a simple and efficient manner. Consider
using cutting-edge tools and products that aid in comprehensive and precise hygiene monitoring of the
entire manufacturing, storage and cleaning process.

Such tools are efficient in identifying the limitations in hygiene, enabling pharmaceutical companies to
take necessary measures to eliminate the bottlenecks and practice high levels of sanitation. There is no
need to conduct complex laboratory tests or submit samples. The tools are easy to use and do not
require any preparation time. Monitoring hygiene performance becomes fast and convenient with such
effective products.
Conclusion

Hygiene in the pharmaceutical industry holds utmost importance to ensure safety of both customers
and employees. Practicing key hygiene measures can help avert contamination in advance and uphold a
clean and germ-free environment.

Attachment 4:

Attachment 5:

PERIODIC REVIEW

 Periodic reviews shall be conducted within the time interval not to exceed 5 years
 In the absence of a risk-based schedule, the periodic review shall default to no more
than 2 years.
 Periodic review of validated process is not required as the evaluation of deviations,
changes and process trends is covered and combined with the Annual Product Records
Review.
 The results of the periodic review shall be documented, reviewed and approved by the
site validation committee.
 The review may result in the need for additional studies (e.g. supplemental validation or
revalidation).
 For processes with systems with lower risk, a periodic review with evidence that the
process or system is consistently producing product meeting its specifications fulfils the
need for revalidation.
 For system that has not been impact assessed, its impact will be assessed to determine
whether the system is a direct impact, indirect or non-impact system prior to periodic
review.

RELATED REFERENCES
FDA U.S Employee Health and Personal Hygiene Handbook –
https://www.fda.gov/media/77065/download

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles -

https://www.who.int/medicines/areas/quality_safety/quality_assurance/
GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf

Annex 2 WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles –
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf

Good Manufacturing Practice Guideline for Pharmaceutical Products - http://www.rrfa.co.za/wp-

content/uploads/2014/01/GMP-Guideline-for-pharmaceutical-products-20141.pdf

Personal, Domestic, and Community Hygiene -

https://www.who.int/water_sanitation_health/hygiene/settings/hvchap8.pdf

Employee Hygiene Practices - https://www.gov.nl.ca/ffa/files/publications-pdf-employee-

hygiene.pdf

Employee Health and Personal Hygiene Practices -

https://tazewellhealth.org/DocumentCenter/View/168/2018-Personal-Hygiene-and-Employee-
Illness-Practices-PDF

Vishalidigitalagency. “Maintaining Hygiene in the Pharmaceutical Industry : A Glimpse of

Effective Practices to Implement - Lindström.” Lindström - India, 19 Oct. 2021,
https://lindstromgroup.com/in/article/maintaining-hygiene-in-the-pharmaceutical-industry-
a-glimpse-of-effective-practices-to-implement/.

2 standard operating procedures. (n.d.). Retrieved March 18, 2022, from

https://www.fao.org/3/w7295e/w7295e04.htm
In-text: (Good Manufacturing Practice (GMP) Resources, 2022)
CONTAMINATION | definition in the Cambridge English Dictionary. (n.d.).

Dictionary.cambridge.org.

https://dictionary.cambridge.org/us/dictionary/english/contamination

BIBILIOGRAPHY

FDA U.S Employee Health and Personal Hygiene Handbook; accessed in:
https://www.fda.gov/media/77065/download
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles -
https://www.who.int/medicines/areas/quality_safety/quality_assurance/
GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf
Annex 2 WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles –
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf
Good Manufacturing Practice Guideline for Pharmaceutical Products - http://www.rrfa.co.za/wp-
content/uploads/2014/01/GMP-Guideline-for-pharmaceutical-products-20141.pdf
Personal, Domestic, and Community Hygiene -
https://www.who.int/water_sanitation_health/hygiene/settings/hvchap8.pdf
Employee Hygiene Practices - https://www.gov.nl.ca/ffa/files/publications-pdf-employee-
hygiene.pdf
Standard Operating Procedure for Personal Hygiene -
https://www.mintrac.com.au/online/personal_hygiene/documents/StandardOperatingProcedure
Sample.pdf
Employee Health and Personal Hygiene Practices -
https://tazewellhealth.org/DocumentCenter/View/168/2018-Personal-Hygiene-and-Employee-
Illness-Practices-PDF

REVISION HISTORY

There is no any evidence of revision history since the document will be processed for review
and approval.