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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

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