PUBLIC NOTICE FOR PPB-UNAUTHORISED MANUFACTURERS OF ALCOHOL

PUBLIC NOTICE FOR PPB-UNAUTHORISED MANUFACTURERS OF ALCOHOL-BASED HAND SANITIZERS

For the duration of the Public Health Emergency declared by the World Health Organization on January 30, 2020 posed by COVID-19, the Pharmacy and Poisons Board (PPB) does not intend to take action against entities that prepare alcohol-based hand sanitizers for consumer use and for use by health care personnel in hospitals or other health care settings provided the following conditions are met: 
  Condition Provision
1.      Ingredients The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:
a)    Ethanol that is not less than 94.9% v/v OR   Pharmacopoeia grade Isopropyl Alcohol (IPA)
b)    Glycerin OR glycerol USP or Food Chemical Codex (FCC) (also known as “food grade”) 
c)     Hydrogen peroxide
d)    Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.
2.      Quality of Ethanol When using Ethanol based formulation, the ethanol should be denatured. The Ethanol can denatured by the Ethanol producer or at the production of the finished hand sanitizer product. 
3.      Manufacturing Formula The hand sanitizer is manufactured based on the following World Health Organization (WHO) recommendate formula:
a)    Ethanol formulated to 80% v/v in an aqueous solution; OR Isopropyl Alcohol formulated to 75%, v/v in an aqueous solution 
b)    Glycerin (glycerol) (1.45% v/v). 
c)     Hydrogen peroxide (0.125% v/v). 
d)    Sterile distilled water or boiled cold water. 
4.      Documentation The manufacturer pays particular attention to ensure the correct amount of the active ingredient (ethanol or isopropyl alcohol) is used in the manufacture of hand sanitizer and is documented. 
At the minimum, the firm should adopt a master batch production document  recommended by the Pharmacy and Poisons Board  (Annex 1) or equivalent for  documenting key steps and controls to assure each batch matches the formula developed for the hand sanitizer. 
5.       Premises and equipment  The firm ensures that the hand sanitizer is prepared under sanitary conditions and that the equipment utilized is cleaned, well maintained and fit for the purpose. 
6.      Quality Control The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy. 
The sample tested can be performed on in-process material before filling into the final containers to be distributed. 
7.      Presentation  The hand sanitizer product is produced as an aqueous solution and as a gel, and not as a foam or aerosol spray. Manual pump sprays that seal sufficiently to prevent evaporation are consistent with this policy.
The firm packages the finished hand sanitizer product in appropriate packaging for liquid drug products that will seal sufficiently to prevent evaporation of the Ethanol or Isopropyl Alcohol. 
8.      Labelling  Generally the labelling on the bottle supplied to customer should contain at least the following:
a)    Manufacturer details
Name, contacts and Physical location of the manufacturer.
b)    Formulation 
“WHO-recommended hand sanitizer formulation”
c)    Warnings: 
For external use only; do not use on open wounds; Flammable, keep away from open flame and heat; Avoid contact with eyes, ears, and mouth. Stop use and ask a doctor if irritation or rash occurs; If swallowed seek medical assistance
d)    Storage 
Store between 15-30oC; Keep out of the reach of children; 
e)    Date of production and expiry and batch number
f)     Direction of use:
Apply a enough alcohol-based hand sanitizer to cover all surfaces of the hands. Rub hands until dry.
In case of contact with eyes, rinse eyes thoroughly with water
g)    Composition:
%ethanol or %isopropanol, glycerol and hydrogen peroxide and purified water.
h)    Net content;
In Volume; milliliters, liters  
9.      Registration of the entity with PPB Firms register their facility and list these products in the Pharmacy and Poisons Board  Drug Registration and Listing on PRIMS
10.          Responsibility of product quality The firm commits to accept responsibility in cases of adverse event reports for any products they manufacture, and submit adverse event reports to PPB in compliance to guidance on adverse event reporting requirements accessible on PVeRS.
 
This temporary authorization to manufacture alcohol-based hand sanitizer products and list them as over-the-counter product lasts for the duration of the COVID-19 public health emergency declared by the World Health Organization. The temporary authorization shall lapse once the public health emergency is declared over.

Click here to download the template for documenting your production.