Study Set Content:
Records for each testing, assay result and release or rejection of starting materials, intermediates, bulk and finished product should be maintained ¨ These records may include : (i) () of test (ii) () of the material (iii) () name (iv) () of receipt (v) Original () number if any
Date, Identification, Supplier, Date, batch
(vi) Batch () (vii) () number (viii)() received (ix) Date of () (x) Quality control ()
number, Quality control , Quantity, sampling, results
consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it
INTERNAL AUDITS
An internal audit may be conducted by ()or a () designated by the management for this purpose
outside or independent specialists , team
STORAGE PRINCIPLE
FIFO
CONTRACT MANUFACTURING AND ANALYSIS
SWOT ANALYSIS, WRITTEN CONTRACT
COMPLAINTS
DESIGNATED PERSONS
If the product is defective
PRODUCT RECALLS
The company or person responsible for placing the cosmetic products in the market must () the regulatory authority responsible for cosmetics of each Member State where the product will be marketed, of the place of manufacture or of initial importation before the product is placed in the market,
notify
FDA regulates cosmetics under the (). Under this law, cosmetics must not be adulterated or misbranded.
Federal Food, Drug and Cosmetic Act (FD&C Act)
They must be() for consumers under labeled or customary conditions of use, and they must be properly labeled. Any color additives they contain must be approved for the intended use, and some must be from batches certified in FDA’s own labs.
safe
The law does not require cosmetic products and ingredients, except for (), to be approved by FDA before they go on the market.
color additives
However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly ().
labeled
Except for color additives and ingredients that are prohibited or restricted by FDA regulations, you may use any ingredient in your cosmetic, as long as it does not cause the product to be () in any way.
adulterated
You are legally responsible for making sure your cosmetics are () and properly labeled, in compliance with all the laws and regulations that apply to them.
safe
Secure a () User Account by sending a request to info@fda.gov.ph following the format bellow:
CCRR
2. After securing the CCRR user account, login at the ()(https://ww2.fda.gov.ph)
FDA e-Portal
3. Select () and accomplish the ()
“New Case”, ASEAN Notification Form
4. Download the () and assign the task to ().
Order of Payment, FDA Cashier
Pay the fee at any () Branch or thru online Bancnet payment and wait for the Result of Application
Landbank
