Good Manufacturing Practices (GMP) Requirements for Cosmetics in USA. PDF/PPT

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Good Manufacturing Practices
(GMP) Requirements for Cosmetics

in USA
July 2020


 Overview
 Definitions
 Specific guidance for cosmetics
 Production
 Laboratory controls
 Internal audit
 Complaints, adverse events and recalls


Part 1: Applicable
FDA Regulations


FDA Regulations & Guidance
 The Federal Food, Drug and Cosmetic Act (the FD&C Act) prohibits the

introduction, or delivery for introduction, into interstate commerce of cosmetics
that are adulterated or misbranded (Section 301 of the FD&C Act).

 Guidance for Industry: Cosmetic Processors and Transporters of Cosmetics
Security Preventive Measures Guidance.”


Part 2: Definitions


Terms Definitions

 The supplying of documents or supporting references; use of documentary evidence;

 the documents or references thus supplied;
 the collecting, abstracting, and coding of printed or written information for future reference

Good That part of quality assurance aimed at ensuring that products are consistently manufactured to a
manufacturing quality appropriate to their intended use. It is thus concerned with both manufacturing and quality
practice (GMP): control procedures.

Systematic and independent examination made by competent personnel inside the company, the
Internal Audit aim of which is to determine whether activities covered by these guidelines and related results

comply with planned arrangements and whether these arrangements are implemented effectively
and are suitable for achieving objectives.

Standard operating Instructions on how to perform tasks and descriptions of the approved or required procedures for
procedure (SOP) accomplishing specific quality assurance objectives


Part 3:


Requirements for Documentation

Documentation should:
 Create a mechanism that shows how products are manufactured and tested.

 Defines the organization’s processes and capture every aspect of the
manufacturing process.

 Prevents errors of interpretation or loss of information that may result from
reliance on verbal communication.

 Allows to trace where any problems may have occurred and to take
appropriate corrective action.


Part 4: Records


Records Requirements
Records should:

 Include the origin, receipt, examination, testing, disposition, and use of cosmetic products and its

 Be retained in either paper or electronic format.

 Capture in detail the operations, procedures, deviations from procedures, justifications, instructions
(including training), specifications, protocols, reports, methods, precautions, corrections and other
measures, and other appropriate information related to GMPs.

 Determine whether disposition of rejected materials or returned goods is documented. (For example,
reworking operations, returns to suppliers, and disposals).

 Information on delegated and contracted out activities such as agreements or contracts with third


Part 5: Building and


Buildings and Facilities Requirements
Buildings and Facilities should :

 Have space of sufficient size and adequate organization to prevent selection errors (i.e., mix-
ups) or cross contamination between consumables, raw materials, intermediate formulations
Have the floors, walls, and ceilings constructed of smooth, easily cleanable surfaces

 Have adequate lighting and ventilation, screening, filtering, dust, humidity, temperature, and
bacteriological controls

 Have adequate washing, cleaning, plumbing, toilet, and locker facilities to allow for sanitary
operation; cleaning of facilities, equipment, and utensils; and personal cleanliness; and

 Have fixtures, ducts, pipes, and drainages installed to prevent condensate or drip

 Be under well defined pest control program.


Part 6: Equipment


Equipment Requirements
Equipment should :
 be for the intended purpose to prevent corrosion, accumulation of static material and/or adulteration

with lubricants, coolants, dirt, and sanitizing agents.
 Have the appropriate design and size and should be made of
 Be maintained in a clean and orderly condition, sanitized at appropriate times, and stored in a manner

that protects against splash, dust, and other contaminants
 Constructed to facilitate adjustment, cleaning, and maintenance
 Of suitable size and accuracy for measuring, mixing, and weighing operations
 Calibrated regularly or checked according to an SOP with results documented, where appropriate
 Removed from use if it is defective, does not meet recommended tolerances, or cannot be repaired and

calibrated immediately


Part 7: Personnel


Personnel Requirements
 Personnel supervising or performing cosmetics manufacturing or control should have the

education, training, and/or experience to perform their assigned functions.
 Personnel coming in direct contact with cosmetic raw materials, in-process materials,

finished products, or contact surfaces should wear clean clothing appropriate for the duties
they perform and necessary protective apparel (for example, uniforms, gloves, safety
glasses, and hair restraints).

 Personnel should maintain adequate personnel cleanliness, and be free from abnormal
sources of microbiological contamination (for example, sores and infected wounds)

 Eating food, drinking beverages, or using tobacco should be restricted to appropriate
designated areas away from storage and processing areas

 All personnel and visitors should be properly supervised while in the manufacturing facility;
 Only authorized personnel should be allowed access into production, storage, and product

control areas


Part 8: Raw


Raw Materials Requirements
Raw Materials should :

 Be stored and handled to prevent mistakes (i.e., mix-ups or selection errors),
contamination with microorganisms or other chemicals, and degradation from
exposure to excessive environmental conditions (e.g., heat, cold, sunlight,
moisture, etc.)

 Be held in closed containers and stored off the floor
 Be maintained in containers that are labeled with the identity, lot number, and

control status (release or quarantine)
 Be sampled and tested for conformance with specifications and to ensure the

absence of filth, microorganisms, and other adulterants prior to processing or
usage (Animal and vegetable origin materials and those produced by cold
processing methods should be reviewed for filth and/or microorganism
contamination.); and

 Be properly identified and controlled to prevent the use of materials that fail to
meet acceptance specifications


Part 9: Water


Water Requirements
Water used in Cosmetics should:

 Be used as-is (i.e., directly from the tap) or; if it has been treated before being
used (i.e., has it been treated by such means as deionization, distillation, or
reverse osmosis)

 Have a well-defined quality
 Not be affected by materials used in the water treatment equipment
 Be tested and monitored regularly to verify that it meets applicable chemical,

physical, and microbiological specifications for quality;

Note: The entire system for supplying water used as a cosmetic ingredient is set up to avoid
stagnation and risks of contamination


Part 10: Color
Additives and


Color Additives
Color additives should be:

 Approved for use in your specific cosmetic products (21 CFR parts 73, 74, and 82).

Note: an unlisted color additive be an ingredient of the cosmetic, approval of
a petition for a new color additive is required pursuant to 21 CFR parts 70 and

*A summary chart for color additives can be found on FDA’s website. Color additives
subject to certification must be labeled with the lot number assigned by the Color
Certification Branch3 (21 CFR 70.25(d)) (see exception below4).


Prohibited and Restricted Cosmetic Ingredients

 Certain ingredients are prohibited from use in cosmetic products marketed in
the United States; others have restrictions on their use. Ingredients whose use is
prohibited or restricted are listed in the tables below.

 CFR, specifically 21 CFR part 700, Subpart B, for any additional requirements
regarding specific cosmetic products or their ingredients that may have been
added to FDA’s regulations.


Prohibited Cosmetic Ingredients
Prohibited Cosmetic Ingredients CFR Citation Prohibited Cosmetic Ingredients CFR Citation
Bithional 21 CFR 700.11

Vinyl chloride 21 CFR 700.14 Mercury compounds 21 CFR 700.13

Certain halogenated salicylanilides 21 CFR 700.15

Zirconium in aerosol products 21 CFR 700.16 Hexachlorophene 21 CFR 250.250

Chloroform 21 CFR 700.18

Methylene chloride 21 CFR 700.19

Chlorofluorocarbon propellants 21 CFR 700.23

Prohibited cattle material 21 CFR 700.27


Part 11:


Production Requirements
 Well established written manufacturing and control SOPs should be in place

before the start of the manufacturing and control operations.
 Procedures should include provisions to ensure that:

 The selection, weighing, and measuring of raw materials and the
determination of finished yield are reviewed by a second individual

 Major equipment, transfer lines, containers and tanks used for processing,
holding, or filling are identified to indicate contents, batch
identification/designation, stage of processing and control status

 There are appropriate measures to prevent contamination with
microorganisms, chemicals, filth, or other extraneous material

 There are in-process controls to ensure product uniformity, integrity (for
example, in- process batch weights), accurate fill of mixing containers, and
adequacy of mixing.


Production Requirements
The Following must be ensured during production:

 The theoretical yield for a production batch is compared with the actual yield

 The tamper-resistant packaging and labeling for liquid oral hygiene products and
vaginal products meet the requirements of 21 CFR 700.25

 The storage and handling of packaging materials that are intended to come into
direct contact with the product prevent selection errors and microbiological or
chemical contamination; and

 Finished product packages bear permanent meaningful, unique lot or control
numbers and you have a coding system that corresponds to these numbers


Part 12: Laboratory
Control Requirements


Laboratory Controls
Laboratory controls should include provisions to ensure that:

 Raw materials (including water), in-process and finished product samples are tested or
examined for identity and compliance with applicable specifications (for example,
physical and chemical properties), microbial contamination, and hazards or other
chemical contamination

 Samples are representative of the Lot
 Current finished product samples as well as retained product samples are tested for

adequacy of preservation against microbial contamination under reasonable conditions
of storage and use

 Samples of approved lots of raw materials and finished products are retained for an
adequate time period

 Retained samples are stored under conditions which protect their integrity (for example,
to avoid contamination and deterioration), and are retested at appropriate intervals to
assure continued compliance with established specifications; and

 Returned cosmetics are examined for deterioration, contamination, and compliance
with acceptance specifications


Part 13: Internal
Audit Requirements


Internal Audit Requirements
 Effective procedures for internal audits should be in place
 Internal audit should :

• Occur regularly or on demand
• Be conducted by individuals who do not have direct responsibility for

the matters being audited

 Internal audit follow-up confirms the satisfactory completion or
implementation of corrective actions


Part 14: Complaint
and Adverse


Complaints, adverse events and recalls

 Procedures should be in place for, reception reporting, recording, filing and
evaluating complaints.

 For complaints alleging adverse events involving bodily injury the following should be

• The kind and severity of each reported injury
• The body part involved
• Product and code numbers
• Whether medical treatment was sought, and, if so, the nature of the medical treatment and

the name of the attending physician or other healthcare professional
• Whether resolution of the event occurred, with or without long-term or persistent effects (If long-

term or persistent effects occurred, the nature of those effects
• The name(s) and location(s) of any poison control center, government agency, physicians’

group, etc., to whom formula information and/or toxicity data has been provided; and
• Whether the company is voluntarily reporting adverse events to FDA through the MedWatch



Complaints, adverse events and recalls

 For voluntary product recalls, the guidelines in 21 CFR part 7, Subpart C, should be
considered, including:

• Whether there is a proposed strategy for conducting a recall

• Whether recall notifications are capable of being initiated promptly

• Whether the appropriate FDA district office has been notified of recalls

• Whether recalled products have been identified and stored separately in a secure area until
the firm has made a decision about the proper disposition or correction consistent with the
degree of risk of the recalled product; and

• Whether FDA’s guidance as outlined in 21 CFR 7.59 has been considered


 Guidance for Industry: Cosmetic Good Manufacturing Practices June 2013


For additional information
please contact us at:

Global Regulatory Partners, Inc.
400 Fifth Avenue, Suite 115, Waltham,
Massachusetts, 02451, USA
Phone 781-672-4200
[email protected]