Cosmetic science

Introduction
Cosmetic industry: Cosmetic industry includes colour cosmetics, like foundation and mascara, skincare
like moisturizers and cleansers,haircare like shampoos, conditioners, and hair colours, and toiletries like
bubble baths and soap. Over the past century, the business has expanded dramatically due to changes in
cultural and societal trends, scientific breakthroughs, and rising consumer demand for personal
expression and self-care. Evidence of the usage of cosmetics in ancient civilisations such as Egypt,
Greece, and Rome dates back thousands of years.
However, with the advent of mass production and well-known international brands like L’Oréal, Estée
Lauder, and Revlon, the contemporary cosmetics business started to take shape in the early 20 th century.
Due to consumer desires for natural ingredients, cruelty-free products, and sustainable processes, the
sector is now very innovative and competitive. The industry has also changed as a result of technological
developments like digital marketing, biotechnology, and artificial intelligence, which enable businesses
to better engage customers and customise products to meet their specific demands. Offering goods to
shield the skin from environmental harm, postpone ageing, and increase general skin health, the sector is
also becoming more and more integrated with health and wellbeing. As a result, the cosmetics business
has grown to be a vital sector of the world economy, greatly impacting self-expression, fashion, and
culture.(1)

Drug and cosmetic act 1940 : The Drugs and Cosmetics Act of 1940 is a key piece of legislation in
India, enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics. Its
primary purpose is to ensure that these products meet established safety, quality, and efficacy standards,
protecting the public from harmful or substandard products. The Act has been amended over time to keep
pace with advancements in the pharmaceutical and cosmetic industries.(1)

Key Provisions of the Act:

[Link] of Drugs and Cosmetics

The Act governs both the pharmaceutical (drug) and cosmetic sectors, ensuring that all products in these
categories are safe for use and meet quality standards. It defines drugs broadly, including all medicines
for internal or external use, diagnostic devices, and substances intended for the treatment or prevention
of diseases

2. Licensing and Manufacturing

It mandates that any individual or company engaged in the import, manufacture, or sale of
drugs and cosmetics must obtain the appropriate licenses. This ensures that only qualified
manufacturers and distributors handle such products.
 3. Standards of Quality:
The Act sets stringent quality standards for drugs and cosmetics. Any deviation from these
standards, such as adulteration or misbranding, is a punishable offense under the Act. This ensures
that consumers are protected from unsafe or ineffective products.
4. Prohibition on Misleading Claims

The Act prohibits manufacturers from making false or exaggerated claims about the efficacy or
benefits of drugs and cosmetics. This regulation prevents the dissemination of misleading information
that could harm consumers.

5. Drug Control Authorities

The Act established various authorities to oversee its implementation, including:

- Central Drugs Standard Control Organization (CDSCO). The primary regulatory body
responsible for drug and cosmetic approval, regulation, and control in India.

- Drug Inspectors. Appointed to ensure compliance with the Act, they have the authority to inspect
manufacturing units, take samples, and investigate any violations

6. Penalties for Violations

The Act outlines strict penalties, including imprisonment and fines, for those who violate its provisions.
This includes the manufacturing or sale of substandard, adulterated, or misbranded drugs and cosmetics.

Amendments and Updates:

The Act has been amended several times to keep pace with industry changes, scientific developments,
and public health concerns. Notably, the Drugs and Cosmetics (Amendment) Act of 2008 introduced
stricter penalties and more rigorous enforcement mechanisms.(12)(14)

Drug and cosmetic act 1945

The Drugs and Cosmetics Rules of 1945. were enacted under the Drugs and Cosmetics Act of 1940
to provide detailed guidelines and procedures for implementing the provisions of the Act. These rules
specify the standards, regulations, and processes for the import, manufacture, distribution, sale, and
labeling of drugs and cosmetics in India.

Key Provisions of the Drugs and Cosmetics Rules, 1945:

1. Classification of Drugs and Cosmetics:

2
 The Rules classify drugs and cosmetics into different schedules (e.g., Schedule M, Schedule X) based
on their nature, purpose, and level of control required. These schedules lay down the specific
requirements for manufacturing, storage, and sale.

2. Licensing Requirements

The Rules set out the procedure for obtaining licenses to manufacture, sell, distribute, or import drugs
and cosmetics. Manufacturers must apply for different types of licenses, depending on the category of
product, and they must adhere to Good Manufacturing Practices (GMP) to ensure quality.

3. Quality Control and Standards:

The Rules mandate the testing and approval of drugs and cosmetics before they are marketed. Products
must comply with specified standards of purity, safety, and efficacy as prescribed in official
pharmacopeias. For cosmetics, manufacturers must ensure that no harmful substances are included.

4. Labelling and Packaging

The Rules provide detailed guidelines for the labeling and packaging of drugs and cosmetics. Labels must
include specific information, such as:

- The name of the drug or cosmetic

- Batch number

- Manufacturing date and expiry date

- Contents and usage instructions

- Warnings and precautions (if applicable)

This ensures transparency and safety for consumers.

5. Schedule M and Good Manufacturing Practices (GMP)

Schedule M of the Rules lays down the requirements for GMP, which ensures that drugs are
consistently produced and controlled according to quality standards. It covers essential aspects like:

- Sanitation and hygiene

3
 - Personnel qualifications

- Quality control systems

- Proper documentation and records

6. Control of Sales

Specific rules govern the sale of drugs, particularly prescription drugs (under Schedule H and X). The
sale of such drugs is restricted to licensed pharmacists, and they must be sold only against a valid
prescription from a registered medical practitioner.

7. Provisions for Import of Drugs and Cosmetics

The Rules outline the conditions and processes for the importation of drugs and cosmetics into India.
Imported products must meet the same quality standards as those manufactured domestically, and the
importers must obtain relevant licenses and approvals.

8. Testing Laboratories:

The Rules prescribe the establishment of testing laboratories and appoint qualified personnel to ensure
that the quality of drugs and cosmetics is checked rigorously. These laboratories play a crucial role in
enforcing standards and preventing the circulation of substandard or harmful products.

9. Schedules for Drugs and Cosmetics

The Rules list various schedules that specify requirements related to drugs and cosmetics, such as:

- Schedule M : Good Manufacturing Practices (GMP) for drugs

- Schedule X : Narcotic and psychotropic substances, with stricter control

- Schedule Y. Clinical trials and new drug approval processes

10. Penalties and Enforcement

The Rules prescribe penalties for non-compliance with the provisions, including fines, suspension or
cancellation of licenses, and prosecution under the Act.(12)(14)

LICENSING AUTHORITIES

4
The licensing for the import, manufacture, storage, and sale of cosmeceuticals is regulated by various
administrative authorities both in India and abroad. Below are the conditions required to obtain such licenses
from India and a general overview of some other international jurisdictions:

India:

In India, the Drugs and Cosmetics Act, 1940 governs cosmeceuticals. The licensing authority varies
depending on the nature of the activity (import, manufacture, store, or sale). Here’s a breakdown:

1. Import of Cosmeceuticals:

- Authority: Central Drugs Standard Control Organization (CDSCO), under the Ministry of
Health and Family Welfare.

- Conditions:

- An application must be submitted to CDSCO via the online Sugam portal.

- A registration certificate (Form 41) and import license (Form 10) are required.

- The importer must provide:

- Proof of compliance with Good Manufacturing Practices (GMP) of the manufacturer.

- A free sale certificate from the country of origin.

- Product details, ingredients, labels, and claims for approval.

- Testing facilities or arrangements for the imported products.

- License Fees: Vary based on the number of products to be imported.

2. Manufacture of Cosmeceuticals:

- Authority: State-level Food and Drug Administration (FDA) of the respective state.

- Conditions:

- A manufacturing license is issued under Form 32.

- The manufacturing premises must adhere to GMP standards.

5
 - Quality control laboratories must be established with trained personnel.

- Required to submit product formulations for approval.

- Batch manufacturing records must be maintained.

- Must ensure testing of raw materials and final products before marketing.

- Regular inspections by Drug Inspectors.

- License Fees: Typically based on the scale of the operation and the type of cosmeceuticals being
produced.

3. Storage and Sale of Cosmeceuticals:

- Authority: State-level FDA.

- Conditions:

- A wholesale drug license (Form 20B & 21B) or retail license (Form 20 & 21) is required.

- A pharmacist or qualified person must be present for the sale of certain cosmeceuticals that may
have drug-like claims.

- Storage conditions (temperature, humidity) must comply with the standards.

- Premises must be adequately secured to avoid contamination.

- Renewals: The license must be renewed periodically, as per state regulations.

International Overview:

1. United States (FDA):

- Authority: Food and Drug Administration (FDA).

- Import: Cosmeceuticals must meet the safety requirements of the FDA’s Cosmetic Act.

6
However, unlike drugs, they don’t require pre-approval unless labeled with drug-like claims.

7
 - Manufacture: Must comply with Good Manufacturing Practices (GMP) and proper labeling
regulations.

- Storage and Sale: No specific license is required, but facilities must meet hygiene and safety
standards. FDA conducts inspections.

2. European Union (EU):

- Authority: European Medicines Agency (EMA) and national regulatory agencies.

- Import/Manufacture: Must comply with the EU Cosmetic Regulation 1223/2009. A

Responsible Person (RP) must be appointed to oversee compliance.

- Notification: Products must be notified to the Cosmetic Products Notification Portal (CPNP).

- Good Manufacturing Practices (GMP): ISO 22716 compliance is mandatory.

- Testing: Products must undergo safety assessments, and a Product Information File (PIF) must be
maintained.

3. Japan (PMDA):

- Authority: Pharmaceuticals and Medical Devices Agency (PMDA).

- Import/Manufacture: Requires a Cosmetic Manufacturing License from the PMDA.

- Regulations: Japan’s Cosmetic standards are defined by the Pharmaceutical Affairs Law (PAL).

- Safety Testing Comprehensive safety tests are required, and products must be registered.

Each country has its own set of regulations, and companies looking to engage in the cosmeceutical
business need to carefully adhere to local and international guidelines.(13)

Documentation

In the cosmetics industry, proper documentation and vendor evaluation processes are essential for
ensuring product safety, quality, and regulatory compliance. Here’s a detailed look at both:

1. Documentation in the Cosmetics Industry

8
a. Batch Formula Record (BFR)

This written record details the history of a product batch and the complete production process. According
to the FDA, a batch is a certain amount of a substance that “has a uniform character and quality, within
specific limits.” This includes chemicals, foods, drugs, and other materials.

- Purpose: To document the entire process for producing a specific batch of cosmetic
products.

- Content:

- Batch number and production date

- Raw materials used (including lot numbers, suppliers, and quantities)

- Production process details (steps, times, temperatures)

- In-process control checks (e.g., pH, viscosity)

- Packaging details

- Approval by responsible personnel (quality control, production manager)

-Importance: Ensures traceability and consistency between batches, and aids in troubleshooting if there
are quality issues.(2)

b. Master Formula Record (MFR)

An essential component of nonsupervisory compliance and efficient process control, the Master
Formulation Record is used to verify the particular data for every batch. The preparation of the medical
product is outlined in this comprehensive record of procedures. A Master Formulation Record must be
made for each distinct expression of a compounded nonsterile medicine (CSNP) or compounded sterile
medication (CSP) for more than one instance of CSP from nonsterile component(s), per USP< 795> and<
797> .

- Purpose: A standardized guide that outlines how to produce a specific cosmetic product.

- Content:

- Ingredients and raw material specifications (e.g., cosmetic grade, percentage of each
ingredient)

- Step-by-step instructions for production (temperatures, mixing times, etc.)

9
 - Packaging, labeling, and storage guidelines

- Quality control checks to be performed during production

- Importance: It ensures consistent quality across multiple batches and is essential for
regulatory compliance .(3)

C. products safety report

- Purpose: To ensure that the cosmetic product is safe for consumer use.

- Content:

- Ingredient safety assessments

- Toxicological profiles

- Stability testing (shelf life, storage conditions)

- Microbiological testing (especially for water-based cosmetics)

- Allergens and sensitivity testing results

- Importance: Required for compliance with regulations like the EU Cosmetic Regulation (EC) No.
1223/2009.

d. Good Manufacturing Practice (GMP) Documentation

- Purpose: To comply with cosmetic GMP guidelines (e.g., ISO 22716), which ensure the quality
and safety of cosmetic products.

- Content:

- Standard Operating Procedures (SOPs) for each manufacturing process

- Cleaning and maintenance records of equipment

- Personnel training records

- Documentation of all raw materials, packaging, and finished products

- Importance: Ensures that the manufacturing environment is controlled and meets required hygiene
and safety standards.

10
e. Labeling and Packaging Documentation

Cosmetics in the United States must adhere to FDA labelling regulations under the FD&C Act and
FP&L Act. Labelling includes all markers and other written, published, or graphic material on or
accompanying a product. The FD&C Act requires marker statements to appear on the inside and outside
vessel or wrapper, while the FP&L Act conditions apply only to the external vessel marker. Cosmetics
with false or deceiving marker statements can be considered misbranded and subject to nonsupervisory
action. The top display panel must state the product’s name, nature, and net volume of contents. The
establishment’s name and place of
business must also be stated on the marker’s information panel. The Tariff Act of 1930 requires imported
papers to state the English name of the country of origin on the marker.

- Purpose: To ensure compliance with regulatory standards and to provide clear information to
consumers.

- Content:

- Ingredients list (according to INCI standards)

- Batch number, expiration date, and manufacturing date

- Storage instructions

- Warnings and claims (e.g., hypoallergenic, dermatologically tested)

- Importance: Provides consumers with necessary information and ensures transparency.(4)

f. Recall and Waste Disposal Procedures

must cease trading and distributing the impacted product. Inform visitors, nonsupervisory authority, and
operations in an efficient manner. Remove the impacted merchandise from the designated location,
warehouse, or distribution sites as quickly as possible. Dispose of the recall, carry out a root cause study,
and document its results. Put a corrective action plan into practice to assist another recall.(5)

All items that individuals no longer need and that they either plan to get rid of or have already thrown
away are considered waste. Expired medications, case details that have been thrown away, desecrated
clothing, absorbents, hypes, vials, IV bags, tubing, and waste accessories that contain leftover
chemotherapeutic medication are examples of pharmaceutical waste that may be produced. Open
containers of unusable medications.

- Purpose: To have processes in place for recalling defective products and disposing of waste
responsibly.

11
 - Content:

- Steps for initiating and conducting a product recall

- Communication with retailers and consumers

- Disposal methods for expired or defective products (recycling, incineration)

- Importance: Ensures that defective or harmful products are swiftly removed from the market,
protecting consumer safety.(6)

2. Vendor Evaluation Process in the Cosmetics Industry

Businesses can use the dealer assessment process to evaluate and approve potential suppliers and
merchandisers to see whether they can fulfil their organisational values and scores from previous
contracts. Securing a low-trouble, best-in-class supplier and dealer portfolio is the ultimate goa

a. Vendor Selection Criteria

- Quality of Raw Materials: Ingredients must meet industry standards, and suppliers should provide
certificates of analysis (COA) for each batch.

- Regulatory Compliance: Vendors should adhere to cosmetic regulations, including REACH

(Registration, Evaluation, Authorization, and Restriction of Chemicals) for raw materials and ISO
certifications (such as ISO 22716 for GMP in cosmetics).

- Supplier’s Production Capabilities: Assess the supplier’s ability to provide consistent quality at the
required scale.

- Vendor Certifications: Prefer vendors who are certified to recognized quality management systems
(ISO 9001, GMP certifications for cosmetic ingredients).

- Supplier Audits: Conduct on-site or remote audits to verify compliance with GMP,
environmental, and social responsibility standards.

b. Vendor Qualification Process

12
 1. Pre-Qualification: The initial screening phase, where potential suppliers submit relevant
certifications, company profiles, and product samples.

2. On-Site Audits: Inspecting the vendor’s facilities to assess their quality control, hygiene
practices, and overall operational capabilities.

3. Material Testing: Before approval, the raw materials supplied by the vendor are tested in- house
or at third-party labs to ensure they meet quality standards.

4. Supplier Agreements: Defining terms such as delivery schedules, quality specifications,

penalties for non-compliance, and responsibilities for recalls.

c. Ongoing Vendor Monitoring

- Regular Audits: Vendors should be audited periodically to ensure they are maintaining quality
and adhering to updated regulations.

- Performance Monitoring: Track performance based on delivery timelines, quality of

materials, complaint history, and responsiveness to issues.

- Vendor Scorecard: Evaluate suppliers regularly based on key metrics such as cost-
effectiveness, quality, reliability, and communication.

d. Managing Non-Conformance

- Corrective Actions: If a vendor fails to meet quality standards, corrective actions are taken, such as
additional testing, modifying the contract, or even replacing the supplier.

- Supplier Development Programs: Work with underperforming vendors to help them improve their
processes, offering technical support or training.

e. Environmental and Ethical Considerations

- Many cosmetic companies now consider the environmental and ethical practices of their
suppliers.

- Sustainability: Prioritizing vendors that provide eco-friendly packaging or sustainable

sourcing of raw materials (e.g., palm oil, mica).

- Ethical Sourcing : Ensuring that ingredients like mica or shea butter are not sourced using child
labor or unethical practices.(7)

CGMP AS PER REGULATORY AUTHORITIES :

13
FDA ensures the quality of drug products by carefully monitoring drug Manufacturers’ compliance with
its Current Good Manufacturing Practice (CGMP) Regulations. The CGMP regulations for drugs contain
minimum requirements for the Methods, facilities, and controls used in manufacturing, processing, and
packing of a drug Product. The regulations make sure that a product is safe for use, and that it has the
Ingredients and strength it claims to have.

The approval process for new and generic drug marketing applications includes a Review of the
manufacturer’s compliance with the CGMPs. FDA assessors and Investigators determine whether the
firm has the necessary facilities, equipment, and Ability to manufacture the drug it intends to market.

Cosmetic Good Manufacturing Practices (GMP) relate to a set of comprehensive Guidelines that help
cosmetic businesses consistently manufacture products that are safe and Of high quality. The word
‘cosmetic’ here refers to goods or materials intended to alter, Enhance, cleanse, or groom one’s face or
body. They can range from makeup and fragrances To produ cts such as soap, lip balms, shower gels,
creams, lotions, body powders, and hair Products. Apart from cosmetics, Good Manufacturing Practices
also exist for other consumer Products including food, drugs, and supplements.

GMP is sometimes also called ‘cGMP’. This refers to current Good Manufacturing Practices, which
emphasizes the need for companies to adopt tools and technologies that areConsistent with today’s
standards. As its name implies, GMPs are concerned with theManufacturing or production processes that
impact the safety, consistency, and quality of The end product. Every cosmetic business has a
responsibility to ensure that products created And ultimately sold are safe, effective, and of consistently
high quality. This need is linked To various regulations that govern the sale of cosmetic products. For
instance, in the US, The Federal Food, Drug and Cosmetic Act (Section 301) enforced by the FDA
forbids the Sale of cosmetic products that are “adulterated” or “misbranded”. In Canada, the Food and
Drugs Act (Sections 16 and 18) states that cosmetics sold must be produced and stored in Clean, hygienic
environments.

Safety refers to the prevention of unintentional contamination, spoilage, or misuse of Final products that
may cause undesirable reactions and other health effects. It can involve Practices such as sourcing raw
materials from a reputable supplier, ensuring facilities are Cleaned appropriately, educating staff about
regular hand washing, and proofreading labels Before printing.

Consistency relates to the ability to control manufacturing variables and processes so That a consistent
outcome is achieved each time. For example, the formulation used, the types Of raw materials selected,
the sanitation protocols followed, and the technical ability of the Cosmetic chemist are just some of the
variables that can influence product quality. Each, if Not controlled, can lead to quality variations from
batch to batch. Creating accurate and Thorough documentation, and then following them through, is vital
in reproducing product Quality and achieving consistency.(8)

ICH GUIDELINES FOR STABILITY STUDY :

14
Designing a cosmetic stability study

A stability study should include the following considerations (each of which will be Discussed in more
detail later):

• Identify tests that will “accelerate and predict” the effects of normal conditions of Storage and use.
Where relevant, consider stresses, including temperature, that will enable Assessment Of product
integrity under anticipated product exposure conditions.

• Consider evaluation of critical aesthetic properties such as color, fragrance, texture, And flow,
particularly after exposure to conditions designed to stress each specific Property.

• Consider variation in process conditions.

• Consider the impact of packaging on the contained product, as well as any effects Which the product
might have on the packaging.

General considerations:

1) General Stability of a Cosmetic Product Whether conducted in real time or under accelerated
conditions, tests should be done In order to assure:

• Stability and physical integrity of cosmetic products under appropriate conditions of Storage,
Transport and use,

• Chemical stability, Microbiological stability,

• The compatibility between the contents and the container.

2) Accelerated Stability Tests

Accelerated tests, developed because of the relatively short development cycle for Cosmetic products,
enable the prediction of stability. A commonly accepted practice is To Support the forecasts obtained
from accelerated stability testing by carrying out Periodic post launch monitoring of retained samples
stored at ambient temperatures. The resultant information Can also be useful in further improving the
product and infurther improving the product and in Refining the methodology used for Accelerated
stability testing

15
 Hair
A complex system, hair has peculiar physical and chemical characteristics. It is a complex structure
composed of multiple morphological elements that function as a unit. The three main parts of a
mammalian hair shaft are the cuticle, cortex, and medulla. Coarse hair, including
thick, bearded, and grey hair, contains the medulla, but fine children’s hair does not. Compared to
Caucasians, Asians have more medulla in their coarser hair. Because the medulla creates a point of
weakness that allows cracks to spread down the fiber’s axis, it may play a key role in hair splitting.
Similar to roof shingles, the cuticle is a chemically resistant area composed of microscopic overlapping
scales called keratinocytes. The anatomy of a hair follicle is shown in Figure 1.(9)

Figure 1

Hair follicle anatomy The orientation and form of the cuticle cells in hair provide the differential friction
effect. The cuticle of Asian hair is 6–8 scales thick; it is slightly thinner in Caucasians and considerably
thinner in Africans. African hair’s thinner cuticle layer makes it more likely to break. The lipid layer that
covers the thin proteinaceous membrane known as the epicuticle contains free lipids and 18-methyl
eicosanoic acid (18-MEA). Beneath the cuticle cell membranes are three levels: the A-layer, the
exocuticle or B-layer, and the endocuticle.
Strongly cross-linked proteins, primarily cysteine, are present in all three layers. While the third one has
the least amount of cystine, the first one has the greatest.(11)

Reason for hair loss/hair damage.

1) Stress: Although emotional stress is less likely than physical stress to cause hair loss, it can still
occur in Situations such as divorce, ageing parents, or the death of a loved one.
16
 It would be beneficial to have a hair fall Tip to manage stress and anxiety using yoga,
meditation, and talk therapy.
2) Dietary habits: Vitamin deficiency is the leading cause of hair loss. Hair loss is commonly caused
by low Vitamin B levels and a lack of necessary minerals. It occurs when there is a lack of
nutrients in the diet and the Food is not nutritious.
3) Protein storage: Hair loss is frequently caused by a protein deficiency. If you don’t get enough
protein in Your diet, your body will break down more protein. This depletes the hair of the
required protein for growth and Prevents the inflow of keratin into the hair.
4) Chemical-based products/wrong product: One of the most common causes of hair loss is the use
of Incorrect hair products. It’s always a good idea to utilize products that keep your hair healthy
and prevent hair Loss. Anti-dandruff shampoo and conditioner for dry or damaged hair, for
example, will not help you fix the Problem. Instead, use a shampoo that is designed to help you
combat hair loss in a targeted approach.
5) Heredity: Hair loss can be caused by genetic diversity, which is a significant factor. Hair loss
with a pattern Is inherited by both males and women. Hair loss is caused by a number of genes
that have been found.(10)

Skin

The skin is the largest organ in the human body, providing protection, regulation, and sensation. Here’s a
detailed overview of its anatomy:

Layers of the Skin:

1. Epidermis (outermost layer)

- Stratified squamous epithelium

- 5 sublayers: stratum corneum, lucidum, granulosum, spinosum, and basale

2. Dermis (middle layer)

- Connective tissue

- Divided into papillary and reticular layers

3. Hypodermis (innermost layer)

- Subcutaneous tissue

- Adipose tissue and connective tissue

17
Epidermal Cells:

1. Keratinocytes (90% of epidermal cells)

- Produce keratin

- Provide structural support

2. Melanocytes

- Produce melanin (pigmentation)

3. Langerhans cells

- Immune cells

- Recognize pathogens

4. Merkel cells

- Sensory cells

- Detect pressure and vibration

Dermal Components:

1. Collagen fibers

- Provide strength and elasticity

2. Elastin fibers

- Allow skin to snap back into place

3. Blood vessels

- Supply oxygen and nutrients

18
4. Nerve endings

- Detect sensations (touch, pressure, temperature)

5. Hair follicles

- Produce hair

6. Sweat glands

- Regulate body temperature

7. Sebaceous glands

- Produce sebum (oil)

Skin Appendages:

1. Hair

2. Nails

3. Sweat glands

4. Sebaceous glands

Functions of the Skin:

1. Barrier against external factors (water, temperature, pathogens)

2. Regulation of body temperature

3. Sensation and perception

4. Immune function

5. Production of vitamin D

6. Excretion of waste

19
*Conditions Affecting Skin Anatomy:*

1. Aging

2. Sun damage

3. Skin cancer

4. Wounds and injurie

5. Skin disorders (psoriasis, eczema, acne)

Figure 2

20
PREPARATION OF SOPS OF DIFFERENT EQUIPMENT AND INSTRUMENTS

Making bribes using various instruments and attire A standard operating procedure, often known as a
bribe, is a set of written guidelines that support a regular or repetitive effort made by an organisation. A
successful quality system must include the creation and application of bribes because they give people
the knowledge, they need to complete tasks correctly and enable thickness in the integrity and quality of
a final product. Terms like protocols, instructions, worksheets, and laboratory operating procedures can
also be used instead of the word “bribe,” which isn’t always appropriate.

SOP Preparation

The association ought to have a technique in place for figuring out which processes or procedures require
proof. People who are familiar with the effort and the internal workings of the group should also write
those bribes. These people are subject-matter specialists who use the procedure or carry out the work. It is
possible to use a platoon method, particularly in formulate- tasked procedures where the presence of
multiple individuals is crucial. This encourages "buy- in" from the bribe's implicit druggies. Bribes
should be written in a way that makes it possible for someone with little to no expertise or knowledge of
the process to successfully replicate it unsupervised with only a basic understanding. The section on
labour force credentials should include a remark on the experience required to perform an exertion.

Hands on Instrument

A. Texture Analyser
The Texture Analyser may measure properties including fracturability, chewiness, stickiness,
thickness, suck force, and springiness by performing contraction, extension, cutting, banishing,
bending, and shearing tests, according on the selected inquiry or institution. A tensile cadence that
has unique inspections (a pristine-sword spherical and an acrylic cylinder) that can access a
product’s measured sample and record time,
distance, and force. The device mimics how a mortal cutlet might touch a person’s face and
probe an object’s packages. Preliminary evidence suggests that the setup can measure the
rheological and textural properties of medicinal and cosmetic goods, such as gels, creams, and
embrocation, as well as the rheological characteristics of mortal skin.
The findings involve the examination of mineral oil, glycerine, and water as well as the waterless
outcomes of thickeners such as carbomer and acrylates/C10-30 Alkyl Acrylate Cross polymer
(Ultras-20 obtained from Noveon). Research has also been done on the effects of conventional
surfactants and complicated surfactant phrasings, such as soaps. The findings were interpreted by
taking into account buoyancy, drag, and thick drag force provided by the Stokes equation. The
results were plotted as force as a function of time or distance and were obtained via slow-
directional investigation movement (submergence and submergence) in the anatomised fluid. The
information can be applied to trained panel reviews of tactile product assessments. The brand
stands by this composition.

21
 Figure 3

22
 B. Brookfield Viscosity
Is often used to describe a density measurement made using a Brookfield viscometer, sometimes
known as a Brookfield viscometer. A rotational viscometer is the Brookfield viscometer. A
measuring body (spindle) is submerged in the oil painting and turned at a predetermined speed in
order to determine the density. The dynamic density’s dimension is the force required to maintain
this speed.

Figure 4

23
 C. Tablet Punching Machine
A mechanical device called a tablet press is used to create tablets with a wide range of
accessories, such as medications, nutraceuticals, cosmetics, sketching supplies, and simulated
bullets. In order to fuse the material, a portion must be pressed firmly together with two punches
and a bone to create a depression there.

Figure 5

24
 D. Capsule Filling Machine
A tamping punch is used by the tamping leg capsule filling machine to compact greasepaint. After
reining, the dosing slice will turn to transmit the greasepaint to the next tamping punch.
Greasepaint applied over the dosing slice will automatically fill the holes in the dosing slice. The
greasepaint will then be poured into the capsule body following tamping. The tabletop Hand
Operated Capsule Filling Machine is appropriate for airmen and product batch circumstances. The
machine has 300 holes with 25 x 12 combinations that are constructed of stainless steel in
accordance with GMP guidelines. Through the use of interchangeable corridors and various
machines, the machine can fill capsules ranging in size from 00 to 5. A huge number of skilled
workers have assembled it in a way that allows for smooth operation. The drawing operation
machine require
carefully .crafted components. Machines that are widely used in research facilities, R&D labs,
herbal and neutraceutical medications, and unani and ayurvedic medications

Figure 6

25
[Link] dryer

takes a liquid sluice and turns the detergent into a vapour while the solute or suspense remains a
solid. The solid is typically gathered in a cyclone or barrel. Through a snoot, the liquid input sluice is
dispersed and shaken into a heated vapour sluice. As humidity rapidly escapes the drop, solids
develop. With spray drying, the product of dry flavourings is produced smoothly. Water, carrier, and
taste are all combined into a sluice of hot air as part of the waterless feed material used in the spray
drying process. Usually, the atomised papers don't last long. The components with uncertain flavours
are confined within the driblets. We sometimes use cyclone collectors to recover the greasepaint.
Spray drying is still the favoured encapsulation method since it works inversely well for both water-
answerable and oil-painting-answerable flavour systems. Additionally, it may be smoothly gauged
from the airman factory to the marketable product and is fairly effective.

Figure 7

26
 F. Freeze Dryer
Snap drying procedures because the rates of the components utilised in their unprocessed, natural
state are preserved. By using this point of snap drying, decorative businesses can preserve their
product ingredients in their most fashionable and effective state without having to use new
preservatives. This machine is specifically used for snap-drying products in the cosmetics
industry, such as mesh red snap-dried grease paint, snap-dried masks, and more. Because it is dry
at low temperatures, it can effectively preserve the cosmetics’ original natural exertion and is
appropriate for sustained efficacy and long-term storage. In three stages, the snap teetotaller
operates.
1. Prolonged
2. The first drying process (sublimation)
3. Secondary Adsorption/Drying

Figure 8

27
 G. Homogenizer
Aside from smooth skin, fragrance, and beauty, homogenisers are utilised for a variety of
reasons. By forcing liquid down a tight tube at high pressure, they reduce particle size; the
end product can be used to make anything from delicious drinks to cancer therapies.
Equipment known as homogeniser machines is used to homogenise different kinds of
materials. The pharmaceutical industry has demonstrated that high-pressure homogenisation
can provide more stable products with improved API dispersion. The homogeniser works on
a very straightforward principle: disperse the laser energy, which is usually concentrated in
the beam’s centre, by causing the beam to overlap itself several times, producing a beam with
a greater divergence angle than the original beam.

Figure 9

H. Ultrasonicator
The ultrasonic cleaning machine’s basic idea is to use a transducer to transform the ultrasonic
frequency source’s sound energy into mechanical vibration. Through the cleaning tank wall, the
vibration produced by the ultrasonic surge is transferred to the

28
 drawing liquid. This allows the liquid’s micro-bubbles to continue to wobble under the force
of the sound surge, dissolving and separating the filthy adsorption on the
object’s face. Small vacuum bubbles are created in the liquid when low pressure is applied
because it causes high-intensity ultrasonic swells. During the high-pressure cycle, the bubbles
collapse as they approach their achromatism position. Cavitation causes dissipation,
homogenisation, decomposition, mixing, and birth throughout the ultrasonication process,
resulting in the absence of chemical products from the liquids. The liquid is exposed to high-
power ultrasound, which produces areas of low pressure (known as refraction) and high
pressure (known as contraction).

Figure 10

I. Colony Counting
Estimating the number of cells present based on their demonstrated capacity to proliferate and
multiply under specific circumstances is the ultimate goal of colony counting. The colony
counters can make use of light contrast or fluorescent markers.

29
 Figure 11

30
References:

1. Rohit Parashar Drugs, Medical Devices and Cosmetics Bill, 2022 Published on: Sep 5, 2022

2. Ankur Choudhary’s preparation of BMR

3. Ankur Choudhary preparation of master formulation record

4. Hans Leijs Joost Broekhans Leon van Pelt Quantitative Analysis of the 26 Allergens for Cosmetic
Labeling in Fragrance Raw Materials and Perfume Oils Publication Date: June 11, 2005

5. Sravya Adhikari's LabAn Overview on Pharmaceutical Drug Recalls June 2020

6. . Jim Baird the Concept of Waste and Waste Management November 2016

7. Charles A. Weber John R. Current W.C. Benton Vendor selection criteria and methods
Available online 13 January 2011.

8. [Link] manufacturing-
practice-cgmp-regulation

9. Mithal B, shah R. A Hand Book of Cosmetics. 1st ed. New Delhi: VallabhPrakashan: 2000.

10. Dauber R. Hair: Its structure and response to cosmetic preparations. Clin Dermatol. 1996; 14:105-
12

11. Kamath YK, Weidman HD. Fractography of human hair. J Appl Polym Sci.1982; 27:2809- 3833.

31
12. Ministry of Health and Family Welfare, Government of India. (1982). The Drugs and
Cosmetics (Amendment) Act, 1982. Retrieved from <[Link]

13. [Link]

14. Drugs and Cosmetics Act, 1940 From Wikipedia, the free encyclopaedia.

32