GMP AND QC OF CHURNAS - amam-ayurveda.org
GMP AND QC OF CHURNAS - amam-ayurveda.org
GMP AND QC OF CHURNAS - amam-ayurveda.org
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GOOD MANUFACTURING<br />
PRACTICES(<strong>GMP</strong>) <strong>AND</strong><br />
QUALITY CONTROL(<strong>QC</strong>) <strong>OF</strong><br />
CHURNA (AYURVEDIC<br />
POWDER PREPARATIONS)
Objectives<br />
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
To ensure efficacy of the drug<br />
To ensure potency/quality of the drug ie the<br />
manufactured drug which is released to the<br />
market should be of acceptable quality.<br />
To ensure safety of the drug
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Definition of Churna in Ayurveda(AFI)<br />
It is the fine powder of a drug or drugs .<br />
Synonyms- Rajah , Kshoda
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Modern definition<br />
Powders are solid dosage form of<br />
medicament which are meant for internal<br />
and external use.They are available in<br />
crystalline or amorphous form. Powder of a<br />
single drug is called as simple and that of a<br />
compound formulation is called as<br />
compound powder.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
General <strong>GMP</strong> and <strong>QC</strong> points applicable<br />
to Churnas.<br />
Adequate space for carrying out the<br />
operation.<br />
Separate quality control section<br />
Separate packaging section.<br />
Separate storage section
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
The grinding, packaging and storage<br />
area should be absolutely clean and<br />
hygienic<br />
Grinding area and packaging area<br />
should be fitted with airconditioners,<br />
dehumidifiers, exhaust fan and should<br />
be dust free.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Workers handling the operation should<br />
be free from contagious diseases.<br />
They should be provided with uniforms<br />
, hand gloves, face masks, head caps<br />
etc. There should not be any washing<br />
place like toilets, wash basins in the<br />
grinding, packaging and storage area or<br />
near by it.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Batch processing records should be<br />
maintained from the beginning of<br />
manufacturing.<br />
All machines /equipments to be used<br />
for the purpose should bear clean<br />
equipment tag with last date of<br />
cleaning.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Premanufacturing <strong>GMP</strong> and <strong>QC</strong> of<br />
Churnas.<br />
Authentication and identification of raw<br />
materials by morphological, anatomical, and<br />
chemical parameters.<br />
The raw materials should be dry, free from<br />
foreign materials like sand, muds, stone,<br />
animal excreta and other foreign materials.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
They should be approved for adequate<br />
active principles and should be free from<br />
microbial contaminations.They should be<br />
packed and stored in hygienic and proper<br />
storage conditions.<br />
The raw materials packets should bear levels<br />
containing name of the raw material, quality<br />
approval status, weight and name of the<br />
product for which it has been issued by the<br />
store.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Process of manufacturing<br />
Processes include<br />
Weighing<br />
Sorting<br />
Chipping<br />
Crushing<br />
Grinding<br />
Powdering<br />
Sifting
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Machines and equipments used<br />
Chippers, disintegrators for size reduction.<br />
Crushing machines like jupitor, mirracle mill<br />
for size reduction upto coarse powder form .<br />
Grinders like multimill, micropulverizors for<br />
powdering<br />
Mechanical sifter for separating and filtering<br />
the fine powder fitted with required sieve size.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Mass mixer for mixing the ingredients<br />
Homogenously.<br />
Different sieve sizes to be fitted into the<br />
sifter and pulverizors<br />
All the equipments /machines used for<br />
this purpose should be washed and<br />
dried properly and should bear clean<br />
equipment tag
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Manufacturing process<br />
If there are number of drugs in the<br />
formulation, the ingredients should be<br />
separately powdered and mixed with<br />
the prescribed quantity.(AFI)<br />
Salt, sugar, camphor are separately<br />
ground and mixed at last. (AFI)
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Asa foetida or Hing if to be added, to<br />
be fried, powdered and added.(AFI)<br />
Drugs like Satawari, Guduchi taken<br />
fresh and made into paste form, dried<br />
and powdered.(AFI)<br />
If drying is necessary, it should be done<br />
at low temperature in order to preserve<br />
the volatile components.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
It should not adhere together and absorb<br />
moisture.<br />
They retain therapeutic value for 1 year under<br />
proper packing and storage conditions.<br />
Collection of powdered drugs in clean plastic<br />
drums lined with polythene bags inside. The<br />
polythene and drums should be kept<br />
airtightened till packaging of the powder.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Packaging<br />
After obtaining quality approval, the<br />
powder material should be proceeded<br />
for packing. Packaging machines and<br />
materials should be clean dry and<br />
should bear clean equipment tag. The<br />
packaging of Churnas should be done<br />
in airtight containers.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Storage<br />
The packed materials should be stored<br />
in cool, dry and dark conditions.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Labeling<br />
The true list of ingredients of Churna along<br />
with the specified quantity in metric system to<br />
be displayed on the label.<br />
Name of the texts listed in Schedule-1 of<br />
Drug and Cosmetic Rule along with the<br />
chapter from which the formulae has been<br />
taken.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
The no of ingredients are large, same can be<br />
listed in a leaflet and can be kept inside the<br />
packet and reference should be made on the<br />
level.<br />
Official names of the drug as mentioned in<br />
AFI should be given.<br />
Apart from this, Manufacturing license, date<br />
of manufacture, batch no, exp date, shall also<br />
be mentioned.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
If any ingredients belongs to the Schedule-E-<br />
1, should be leveled with “caution”, to be<br />
taken under medical supervision.<br />
For export purpose, the label should contain<br />
information's as per the directives of the<br />
importing country.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Also the following points should be<br />
mentioned.<br />
Ayurvedic medicine/ Siddha/.Unani medicine<br />
For external use (if specified)<br />
If it is a patent/proprietary medicine .
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Quality analysis<br />
In process<br />
Description<br />
Mesh size<br />
Loss on drying
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Final analysis<br />
Description<br />
Sieve size<br />
Coarse powder-10 / 44<br />
Moderately coarse powder- 22/60<br />
Moderately fine powder- 44/85<br />
Fine powder-85<br />
Very fine powder-120<br />
Contd.
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Loss on drying/moisture content<br />
TLC<br />
Total Ash<br />
Acid insoluble ash<br />
Water soluble ash<br />
Extractive value in water, alcohol and<br />
other solvents
<strong>GMP</strong> and <strong>QC</strong> of Churna<br />
Contd.<br />
Phytoconstituents<br />
Microbial contaminations<br />
Heavy metal limit test for mercury,<br />
arsenic, cadmium, lead.<br />
Microscopic analysis<br />
The above tests should be conducted either in<br />
Govt approved labs or in house labs following<br />
the STPs mentioned in API.
THANK YOU ALL