Administrative Order No. 90 s.

2002
CGMP for Cosmetic Products
Pursuant to the provision of RA 3720- Food, Drugs,
and Devices and Cosmetics Act

Passed on March 18,2002

Objectives
1. To assist the cosmetic industry in compliance with the harmonized
ASEAN Cosmetic Regulatory Scheme.
2. To issue license to manufacture cosmetic products only upon
compliance with CGMP
Statement of Policies
1. The DOH adopts ASEAN Cosmetic GMP Guidelines.
2. Cosmetic products shall be manufactured using methods, facilities
and control procedures adequate to preserve their quality and
safety.
3. The quality of cosmetic products depends on the starting materials,
production, quality control processes, building/facility, equipment,
personnel involved and testing protocols.
DEFINITION OF TERMS:
• BATCH- quantity of any cosmetic product in a given cycle of
manufacture that is uniform in character and quality.

• BATCH NUMBER- designation in numbers or letters or combination

thereof that identifies the complete history of a batch, quality control
and distribution.

• Bulk product- any processed material which has to undergo another

process including packaging operation to become a finished product.
• CALIBRATION- combination of checking an instrument and
adjusting it to bring it within its limit for accuracy according
to recognized standards.
• COMPLAINT- external information claiming a quality defect in
a product
• COMPONENT- any ingredient intended for use of a product,
which include raw and packaging materials, including those
that may not appear in the finished product
• CONTRACT MANUFACTURE- the manufacture in part or
whole of a product by one or more manufacturer (Toll) for
another party (Trader).
• COSMETICS-Any substance or preparation intended to be placed in
contact with the various external parts of the human body or with
teeth and the mucous membrane of the oral cavity
a. Articles to be rubbed, poured, sprinkled or sprayed on, introduced into or
applied to the human body or any part thereof for cleaning, beautifying,
promoting attractiveness, or altering appearance
b. Articles intended for use as to 91 except soap

• CROSS CONTAMINATION- Contaminations of a product with another

material or product.
• DATE OF MANUFACTURE- date of manufacture of a batch
• DOCUMENTATION -all written procedures, instructions and records involved
in the manufacture and quality of products
• FACILITIES- refers to the building, premises and equipment necessary in the
manufacture of cosmetic products.

• FINISHED PRODUCT- product which has undergone all stages of manufacturing

operations and ready for use.

• Good Manufacturing Practice (GMP)- part of quality assurance aimed at ensuring

that products are consistently manufactured to a quality appropriate for their
intended use. It is thus concerned with both manufacturing and quality control
processes and procedures.

• In-Process Control- checks and tests instituted and carried out in the course of the
manufacture of a cosmetic product including checks and test done to environment
and equipment in order to ensure the end product will comply with its
specification.

• LOT- specific identified portion of a batch having homogenous in character and

quality within specific limits.
• MANUFACTURE or MANUFACTURING- complete set of activities to produce a
product that comprise production and quality control from acquisition of all
materials through processing and subsequent packaging to the release of the
finished product.

• MASTER FORMULA- document or set of documents specifying the starting

materials with their quantities together with a description of the procedures and
precautions required to produce a specified quantity of a bulk product as well as
the processing instructions, including the in- process controls.

• Master packaging document- document or set of documents specifying the

materials with the procedures and precautions required to package a quantity of
finished product

• PACKAGING- part of the production cycle applied to a bulk product to obtain the
finished product.
• PROCEDURES- description of the operations to be executed, including
the precautions to be implemented directly or indirectly related to the
manufacture of a finished product.
• PROCESSING- part of production cycle starting from weighing of raw
materials to finished product.
• PRODUCTION- all operations starting from preparation of a product,
from acquisition of starting materials through processing and
packaging, to its completion as a finished product.
• PRODUCT RECALL- process of withdrawing one or more batches or all
of a certain product from market distribution.
• QUALITY ASSURANCE- activity of providing evidence needed to
establish confidence that the quality function is being performed
• QUARANTINE- act of holding off a material for use, or a product of a packaging
or distribution by setting it apart or by system duly validated pending a decision
of its release or rejection.
• RAW MATERIAL- any substances going into or involved in the processing of a
finished product.
• RECOVERY- incorporation of all or part of previous batches to come up with the
required quality into another batch at a defined step of production.
• REJECTED- status of materials or products which are not permitted to be used for
processing, packaging or distribution.
• RELEASED OF PASSED- status of materials or products which are permitted to be
used for processing, packaging or distribution.
• REPRESENTATIVE SAMPLE- sample representing the lot, the batch, or the total
amount of materials based on sampling plan.

• REPROCESSING- reworking of all or part of a batch of product of an unacceptable

quality from a defined step of production in order that its quality may be
rendered acceptable by one or more additional operations.

• RETURNED PRODUCT- any finished product which is already in distribution and

sent back to the manufacturer or distributor due to complaint, damage,
expiration, validity or other reasons such as the condition of the container or
package which may cast doubt on the product identity, quality, strength and
safety.
• SANITATION- measures taken to preclude contamination of processing equipment
and/or area so as to prevent contamination of bulk or finished product.
• SPECIFICATION- the documents that describe the requirement to
which the material, product or service has to conform.

• STARTING MATERIAL- raw/chemical materials and packaging materials

used in the production of a finished product.

• SUBSTANDARD- any condition that fails below the established

specification or requirement for manufacturing