ASEAN Cosmetic Good

Manufacturing Practice

Evan Caunca
2021-05008
MS Cosmetic Science, CEU Manila
Developments in Cosmetic Jurisprudence and Ethics
Quality Management System

- A quality system should be developed, established and

implemented as a means by which stated policies and
objectives will be achieved. It should define the
organisational structure, functions, responsibilities,
procedures, instructions, processes and resources for
implementing the quality management.
- QA documentation system
- Auditable, Internal, External and Regulatory Auditors
- Regularly reviewed by Risk Management Team
- Production and Quality Manager should be separate entity
 Quality Management System
Quality Policy- includes the company objective
Commitment to quality and continuous
improvement.
Standard Operating Procedures
Quality Manual- includes, QMS scope and
description, Business Process Model,
Definition of responsibilities of all
personnel, relevant references and
appendices.
Work Instruction
Quality Management System

- The quality system should be structured and adapted to

the company’s activities and to the nature of its products
and should take into consideration appropriate elements
stated in this Guidelines.
1. Quality Management System

- The quality system operation should ensure that if

necessary, samples of starting materials, intermediate,
and finished products are taken, tested to determine
their release or rejection on the basis of test results and
other available evidence related to quality.
- Ensure traceability of raw, packaging materials to finished goods
- Test records, Manufacturing Records, and monitored environmental
conditions should also be recorded
-
2. Personnel
 Personnel are a company’s greatest resource.

Training them well in GMP Principles ensures

the health, and protection, of personnel and
products, and fosters an environment that
leads to a safe, smooth, and satisfactory
system of Quality Assurance and
Manufacturing
 Clear description of their roles is a must.
Managing
Lorem Ipsum
Director

Sales & Marketing

Lorem Ipsum Quality Control Head
Head Production Head

Sales Marketing
Lorem Ipsum Processing Packaging IPQC

Individual roles and responsibilities must be clearly understood by each individual concerned,
while having a sufficient number of qualified personnel to carry out the tasks.
 Key Personnel ideally should be appropriately qualified,
and/or possess adequate practical experience.
● Chemistry
● Biochemistry
● Chemical engineering

01 Desirable qualifications ●
●
Microbiology
Pharmaceutical Sciences and Technology
● Toxicology and Pharmacology
● Other related science or GMP-related subjects

● Under professional supervision

● Able to take difficult decisions in a professional and

02 Practical Experience
●
scientific manner
Resolve problems encountered in manufacturing
and QC

Each individual must have a written job description, and have no overflow of responsibility so as
to not present a risk to quality.
 Production and QC teams have very crucial roles,
yet may share some responsibilities

Head of Production Head of Quality Control

● Manages production and storage to
appropriate documentation
● Approves in-process QC
● Evaluates production records
before passing to QC
● Maintains entire production area
● Approves SOPs ● Approves or rejects materials,
● Control & Monitor bulk and finished goods, etc.
environment, ● Evaluates batch records
storage conditions, ● Carries out testing requirements
and plant hygiene ● Maintains laboratory
● Retention of records ● Calibrates control equipment
 Training, as is learning, is a daily and life-long habit.
Periodical assessment of practical
effectiveness
1
● Staff working with hazardous
materials should be given specific
training
● Deeper understanding of QA should
On induction and be discussed
continuous training on
certain tasks 2 Initial training in accordance
with a standardized program
● Specialized (SOPs)
training as part of
3
induction into a ● All personnel whose
new specialized duties take them into
task production
● Training records ● Into control laboratories
should be kept ● Others whose activities
could affect the quality of
the product
Hygiene is a crucial factor in the health of the entire system.
Use of
protective
clothing
Health
Examination

Staying home
when sick
Frequent hand washing

Food-free
Smoke-free

Personnel training in hygiene is key to preventing viral

outbreaks, and ensures the health and well-being of all.
3. Premises
Building and layout design should ensure suitability for the intended
operations, and should minimize the risk of cross-contamination and
errors during all aspects of manufacture, filling, and packaging.
 Congruent to this objective, the layout should also allow for effective
cleaning and maintenance in order to avoid build up of dust or dirt, and in
general, any adverse effect on the product or the surrounding environment.

Floors
Solid concrete / with Epoxy
Polyurethane Resin Finish
Tiles

Walls & Ceilings

Block Structural Wall of Joint & Frames
High Density Should be designed
Smoothly Plastered with ease of cleaning
Waterproofed with in mind
Acrylic Paint or High
Polymer Enamel
Ventilation and air filtration is an equally important consideration,
specifically in the processing and filling areas.

Ventilation Fan with Filter

Packaging Area should be laid out to prevent mix-ups or cross
contamination.
QC Laboratory should have ample space for proper storage.
All other areas must be properly defined, labeled, and have sufficient
capacity as to fulfill the purpose that their designated area serves.

This also includes the need for orderly and logical movement for
personnel.
4. Equipments
Operated by Suitable for
Trained Intended
Personnel Use Equipment
Production,
Quality Control,
Calibrated Reproducible
System
with and Valid
Reference Outputs
Standard
 Purchase
aligned to
Can be product
validated specifications

Prevent
Contamination
Properly
Calibration installed at
according right facility
to
frequency
of use
Basic Principle
and Requirements
Preventive
Maintenance
Operational
and Cleaning
Manual
 304 Stainless Steel
Excellent corrosive
Design and property
Construction
316 Stainless Steel
● Materials should not Additional
be absorptive, corrosive property
vs chlorides
reactive and additive
● Easy to clean
● Appropriately Always ask your
designed not to affect supplier how to
clean the
the product
equipments during
● Explosive proof
early procurement
process.
Pipes and
Pipelines

● Labeled
● Shows flow direction
● Specified content
● Accessible at safe
location
● With monitoring
control if needed -Designate a place for pipes e.g. beside walls
-1 pipe for specific content
-Create a monitoring system for maintenance
Safety Devices Flexible Hose
Appropriate for the ● Compatible with the
content, checked and product/ingredient
calibrated ● Can be cleaned easily
● Easy to identify

Air Pressure Regulator

Control Panel
Location and
Installation
● Equipment
● Avoid Congestion mapping
● Identifiable ● Equipment for
● Accessible during one process in
operation one room
● Minimize risk to error ● Spacious
● Easy to clean and
maintain
● Avoid contamination
Maintenance

● Cleaning ● Equipment Cleaning Tags

● Maintenance ● Cleaning Work Process
● Calibration ● Preventive Maintenance Plan
● Change control ● Equipment Audit
● 3rd Party Calibration or In-house Calibration
● Equipment Status Tag
● Equipment Change Control Process
Equipment Training

● Training Upon Purchase

● Standard Operating Procedure Training
● Cleaning Instruction
● Equipment Minor Repair Instruction
5. Sanitation and Hygiene
Cleaning Principle

Create a cleaning systems to prevent any form of

contamination
● Personnel
● Premise
● Equipment
● Raw, Packaging and Intermediate materials
● Products
 Hygiene
Sanitized
Personnel

Sterile Products Premise Clean

Cleaning Sanitized

Principle

Raw,
Packaging,
Sterile Equipment Sterile
Intermediate
Materials
Hygiene
● Personal Hygiene ● No jewelries, nail
Guideline lacquers and artificial
● Hand washing eyelash
guideline ● Designated eating
● Hand washing area and rest area
● Appropriate PPE ● Limited movement
● Healthy, no Illness based on assigned
on Duty work
● Medical Exam and The company should
APE create a complete
● No open wound guideline in
maintaining health in
hygiene of the
personnel
 Housekeeping-Premise

● Sufficient space for easy cleaning

● Well designed cleaning program
● Cleaning records
● Designed to prevent
contamination
● Pest Control
● Design can be cleaned easily
● Entry points should prevent entry
of insects
Housekeeping-Sanitation Facilities
Water Supply- accessible
Cleaning Equipment- accessible
Plumbing- appropriately located based on activity
Toilet Facilities- outside the production area
Hand Washing Area- on production area entry
Garbage Disposal Room- outside the production
area, with appropriate disposal system
Changing Area/Locker- outsider production area
Cleaning
Equipments
● Equipment material should not be corrosive and easy to
clean
● Ask your supplier how to clean the equipment on the
early stage of procurement process
● Cleaning and Sanitation Guide for equipment
○ Foam
○ High Pressure
○ Clean in Place
○ Clean out Place
○ Mechanical
Sanitation

● Sanitation to prevent microbial contamination

● Extra layer of cleaning specifically for equipment with
direct contract with the product
● Non Chemical and Chemical Sanitation
10. Storage
 STORAGE

Scope
- Storage of Raw Materials
(Ingredients and Packaging)
- Storage of Finished Goods
- Distribution of Cosmetics
Products
Components of Good Storage Practice

1. Premises/warehouse
2. Storage Facilities
3. Personnel
4. Stock management and control
5. Documentation
Premise/Warehouse
- Suitable building materials, provide
protection, secured from unauthorized
person, properly maintained.
 Premise/Warehouse
- Adequate space provided for all
storage activities to prevent mixed
up and damage of the materials and
products.
Premise/Warehouse

- Should have dedicated and segregated areas for

receiving, loading, unloading, storage of RM and FGs.
- Should be separated from production.
- Sampling area for incoming materials should be provided
to avoid contamination.
- Dedicated areas for Rejected/damaged stock , Returned
goods from customers, Recalled goods, “Not for Sale”
products.
Premise/Warehouse
Premise/Warehouse

- Daily monitoring of storage environment (temperature

and humidity) with defined monitoring points/locations
and frequency.
- Thermo hygrometers should be calibrated, and certificate
of calibration should be available.
Premise/Warehouse

- Storage temperature requirement should comply with

the labeling requirements and nature of the product.
- Pest Control program/plan, Third party or outsourcing
(contract should be available), approved safe pest control
agents.
Storage and Facilities

- Sufficient lighting as per standard of lightings intensity

(expressed in Lux)
- Compliance on Safety Requirements ( PPEs for handling
raw materials, safety signs, alarm system, fire
extinguishers, etc.)
 Storage and Facilities

- Availability of Forklifts, Trolley,

computers, Generators
 Warehouse Personnel

- Qualified Personnel- sufficient experience and in

good health status.
- Sufficient number of personnel- organizational
chart
Warehouse Personnel

- Appropriate and continuous training programs- annual

training refresher.
- Conduct basic training- e.g.: store / warehouse
management, inventory , safety, hygiene, good
housekeeping (5S).
Warehouse Personnel

- Documented procedure of all processes

- Control system/ Risk Registry
Stock Management Control
- All deliveries should be inspected during receiving
- containers are not damaged
- quantity of deliveries
- Labels
- suppliers name & address
- product information
- product name, batch no
- manufacturing/expiry date
Stock Management Control

- Systematic Storage System- manual encoding or thru a

system
- Sufficient passageways for easy movement
- Proper labelling of stocks
- Scheduled stock check/ inventory count
Stock Management Control

- Product Release
- Follow FIFO, monitor the quality of the product
during transport and at delivery.
- Available written procedure on how to manage
returned goods- defined area, labelling and
investigation (RCA) related to quality and safety.
- Written procedure for the management of rejected or
damaged products- defined area for rejected lots(with
lock), labelling and RCA related to quality and safety and
disposal of rejected items.
Stock Management Control
- Established written procedure on handling product
disposal
- disposal method should be according to the company and country
regulations
- regulatory requirements should be always observed
11. Contract Manufacturing
Contract Requirement

Scope
It applies to the contract giver and contract acceptor
(cosmetic manufacturing facility and testing /analysis
laboratory).

Example:
ISCI as the contract giver
Siegranz as the contract acceptor
Contract Requirement

- Conditions between two parties should be clearly

defined, agreed and controlled to avoid
misunderstanding.
- Established duties and responsibilities.
- Must be binding in accordance with the respective
legislation of the ASEAN member countries.
Contract Requirement

❑ CM acceptor must comply ASEAN GMP and duly

accredited by the relevant appointed accreditation
agencies (FDA, SGS, TUV, Intertek).
Contract Requirement
- Scope of work must be identified between the 2 parties
- For contract manufacturing
•Formula development
•Prototype and acceptance evaluation
•Safety and efficacy tests, if any
•Packaging development
•Raw and packaging materials supply and testing,
etc.
- For contract analysis
•Sampling: sampling plan, quantity of sample,
sampling containers
•Test Protocol
•Test Format, etc.
Contract Requirement

- List of products for contract manufacturing

- finished product specifications including directions for
use
- packing sizes, container specifications and labeling
requirements
- shipping labels and instructions
- storage condition, etc.
Contract Requirement

- Both parties is responsible for the

quality testing
- The contract giver have the right to
conduct audit on the CM facility
- The contract acceptor shall not
deviate or make any changes to the
formulation and/or process/es agreed
upon by the parties for the
manufacture or analysis of the
product without the prior consent of
the contract giver.
12 Complaints
PRODUCT COMPLAINT PRINCIPLE

“All complaints and other information concerning potentially

defective products must be carefully investigated according
to written procedures.”
ROLES OF MANUFACTURER

- The manufacturer should be responsible to impose

self-regulation upon itself and to remove substandard or
defective products as fast as possible from the market.

- It would be in the interest of the company to assign

responsible person to:
investigate product complaints
identify & rectify product shortcomings
manage product recalls
monitor adverse events
 COMPLAINT HANDLING
PRINCIPLES
1. Complaints should be handled in accordance with a written
procedure
2. Carefully reviewed and handled positively
3. Managed by an appointed responsible person
4. Must be given importance
5. Thorough investigation of the cause is essential
6. A major source of information and learning
7. Enable possible production defects to be remedied before
they lead to a recall.
8. Necessary actions taken - even a recall decision
9. All complaints should be well documented
RESPONSIBLE PERSON
- Within each company a person with adequate knowledge
shall be assigned the task of dealing with complaints.
- This person must also have the authority to decide the
measures to be taken.
COMPLAINT HANDLING
PROCEDURE
- Assigned responsible person
✔ May be authorized person
✔ If not, must advise authorized person of results
✔ Sufficient support staff
✔ Access to records
- Written procedure describing action to be taken
- Acknowledge and respond to complainant within a
reasonable period
- Record written and verbal comments
- Investigate and review to identify the complaint trend
- Appropriate follow up actions
 INVESTIGATION

- The person in charge of complaints is responsible for initiating the

investigation immediately. The person responsible for Quality Control should
normally be involved in the investigation.
- The investigator is responsible for the investigation which has to be carried
out immediately. The investigation shall be documented in writing.
- If a product defect is discovered or suspected in a batch, consideration should
be given to determine whether other batches are also affected.
- The investigation should also cover:
distribution condition
condition under which the product is used
INVESTIGATION RECORDS

Records of Complaint Investigation describe :

• Name of product
• Name of active substance, if any
• Product type
• Batch number
• Name of complainant and nature of complaint
• Records, retention sample investigated, other batches
reviewed and staff interviewed
• Result of investigation: “Justified” or “Not justified”
• If “justified”, actions taken to prevent reoccurrence
• Sign-off upon completion
REMEDIAL ACTIONS

- The person in charge of complaints is responsible for the

remedial action decided upon following the outcome of
investigation.
- If it has been decided to make a recall some of the
procedures stated in Product Recall Procedure shall be
applied.
- The company management shall discuss possible steps to
prevent defects, and take over responsibility for further
handling of the cause of the complaint from the person in
charge of complaints.
Responses

- Complaints shall always be answered by person(s)

assigned by the company.
- Immediate response should be given to the complainant
and the manufacturer must be notified of the complaint.
- If the person who complains is informed of the outcome
of the investigation over the telephone, the date and
information provided shall be noted.
COMPLAINT DECISION

- Complaint justified
Actions to prevent reoccurrence
Ongoing observation of process
Recall product may be required

-Complaint not justified

Advise customer of findings
Appropriate marketing response
COMPLAINT & DEFECTS CLASSIFICATION

- If complaint is justified, then there has been a failure of

the quality system
- Once defect has been identified, company should be
dealing with it in an appropriate way, even recall.
- The definition of defects is useful.
- The following system has been found in some countries:
Critical defects
Major defects
minor defects
COMPLAINT & DEFECTS CLASSIFICATION

- While complaints can be classified as:

Medical (e.g unexpected adverse reactions)
Technical (e.g quality,packaging or labeling defects)
Trends Review

- As complaints are investigated and records are built up,

then trends may start to become clear.
- Regular review of trends required to establish :
Reoccurring problems
Potential recall or withdrawal
- Inform competent authority of serious quality problems
Documentation

Documentation of complaint investigation :

✔ Each individual complaint and attached documents shall
be filed.
✔ A final report shall be prepared and documented.
✔ In the event of product recall (product safety) the
authority should be notified
Reporting

- Procedures shall be developed within the company for

the receipt of reports on complaints both inside and
outside working hours.
- It is important that complaints reach the person in
charge.
- All complaints are reported in the complaint form. In case of
urgency can be made over the telephone and confirmed in
writing.
13 Product Recall
Product Recall

• Product recall is a process taken by the responsible

person who placed the product on the market, to remove
or withdraw a particular cosmetic product from all links of
distribution.

• The removal or withdrawal may be due to critical quality

defects discovered or serious adverse cosmetics reactions
reported which might cause health risks to users during
and after distribution of the product.
Product Recall

● Safety Alert :
Advice regarding a specific situation of a product, which is
not conforming with the safety specification.
When there is a risk of significant hazard to consumers of
a product which has been distributed on the market ,the
manufacturer should disseminate the safety alert through
mass communication media available including
newspaper, radio and television
Product Recall

● Withdrawal:
Removal of product from sale or use for reasons not
connected with quality and safety such as change of
packaging etc. as a marketing strategy

● Recall for Product Correction:

the removal of product for rework.
Reasons of Product Recall

Voluntary recall :
● Customer complaint
● Detection of quality and safety failure after release
● Result from the ongoing stability testing
● Result of an inspection
● Tampering
● Adverse event reporting

Mandatory recall :
● Directed by the national regulatory authorities
Recall Principle

There should be a system to recall products known or

suspected to be defective from the market promptly and
effectively.
Basic Requirements

● Preferably, responsible person is independent from seller

or marketing
● Must have an effective recall SOP in place.
● Distribution records should be readily available to
responsible person.
● Secure storage of goods awaiting disposition.
● For mandatory recalls :
must notify all NRA and all countries to which product
may have been distributed.
Must liaise with NRA for all recall events .
Basic Requirements

● If required, public warning/notices will be issued in order

to alert the customers.
● Progress recorded and final report issued
● Reconciliation between delivered and recovered
quantities.
Classes of Recall

● Unless the relevant authorities have already specified the

degree and level of a particular product recall, the class and
level will be decided by the product recall committee based on
the risks involved .
● The product recall committee shall comprise of personnel
who are responsible for the execution and coordination of
recall. The persons responsible should handle all aspects of
the recalls with the appropriate class of urgency.
● In cases of product recall initiated by the manufacturer, the
product recall committee must inform the relevant
authorities immediately of this decision when necessary.
 Recall Classification

The class of product recall is classified according to the

seriousness of quality defects and adverse events of the products.
Level of Recall

The level of the

product recall
depends on :
• the nature of the
problem,
• the extent of the
product's
distribution and,
• the degree of
hazard involved.
Notification of Recall

- A sample of the recall notice must exist.

- Recall notices must be mailed in envelopes or faxed
which can be clearly recognised as such.
- The notification of recall should include:
✔ The name of the product, and pack size
✔ The product batch number
✔ The nature of the defect
✔ The action to be taken
✔ The urgency of the action (with reasons, indication
of health risk, as appropriate)
Recall Notice Dissemination

Level A: To all Customers

☞ This level of recall will apply to Class I recall and carried
out in the comparatively rare instances when it is
necessary to try to stop all use of a product and to recover
stock that has reached the end user.
☞ When there is imminent danger the public are warned by a
media release which is meant to urgently alert the public by
radio, television and the press.
Recall Notice Dissemination

Level B: All Points of Sales

☞ This level of recall will apply to Class II recall.
☞ All wholesalers will be identified and asked to provide
contacts by telephone to obtain a list of all points of sale.
These points can be established through a distribution
record.
☞ Recall notices will be mailed or faxed to all points of sales. At the
same time representatives from the company will be sent to these
points of sale to retrieve the stocks.
Recall Notice Dissemination

Level C: To All Warehouse and Stockist

☞ This level of recall will apply to Class II recall where
consumers are not at any risk from administering the
products.
☞ The wholesalers and stockists will be contacted by the
company representatives so that arrangement can be made
to retrieve all stocks concerned from the wholesalers and
stockists.
Responsibility

• The General Manager (the highest person in management)

has the ultimate responsibility to direct the prompt
removal of defective/recalled products from the market.
• The Quality Control Manager is responsible for the
assignment of a Qualified Recall Team and determining the
recall strategy.
• The Recall Team is responsible to carry out all recall
activities under the supervision of Recall Team Leader.
• The Recall Team Leader is responsible for execution and
coordination of all recall activities and to evaluate the
effectiveness of the recall in a suitable interval.
Product Recall Management

Organizing the return of the recalled product :

● Producer should settle a centre to collect and store all
returned stocks of the recalled product;
● All needed data, quantity, and nature of product shall be
noted down by this centre as records;
● Depending on the class of product recall, the producer
should manage the most effective and appropriate mode
of transportation of recalled products;
Product Recall Management

● All stocks of the recalled products will be stored

separately in a different section of the warehouse to
prevent any mix-up.
● The producer has to prepare a progress report of the
recall including the reconciliation between the delivered
and recovered quantities
Fate of Product Recall

• All available records and information on the returned

stocks will be collected for evaluation purpose;
• A report of the affected stocks will be presented to the
Product Recall Committee and the fate of the product
shall be determined.
• The recalled product may be reworked if it meets
appropriate standards and specifications e.g. mislabelling
…, etc;
• The recalled product shall be destroyed if the conditions
under which the cosmetics product casts doubt on its
safety, identity and quality;
Fate of Product Recall

• Upon approval from the relevant authorities, proper

destruction with appropriate precautionary measures will
be taken to ensure total elimination of affected stock;
• Detail destruction process, the date and quantity shall be
recorded.
The Final Recall Report

• Final Recall Report, a written evaluation summarizing the

circumstances leading to the recall, corrective actions
taken and the disposition of the recalled product, will be
prepared by the Recall Team once the recall is considered
closed.
• Report consists of:
Fate of the products
Reconciliation result
Disposal report/certificate if any
Copy of alert notification or any other form of
notification
Documentation

• Quality Control department is responsible to keep in a

Recall File :
✔ effectiveness checklist,
✔ the Recalled Product Record,
✔ the Progress Report,
✔ the Recall Report, and
✔ all other pertinent correspondence.
• The recall files will be retained for at least one year after
the expiration date of the recall lot.
References

- ASEAN GUIDELINES FOR COSMETIC GOOD

MANUFACTURING PRACTICE