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    Quality Control in Homoeopathy: Definition

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    11 Isha Chitnis
    Quality control in homeopathy ensures standardized, safe, and effective medicines by maintaining quality throughout the production process from raw materials to finished products. Key aspects of quality control include establishing specifications for materials and products, using qualified personnel and equipment, maintaining suitable environments and infrastructure, and following standard methods of preparation and packaging. In India, quality control is regulated by the Drugs and Cosmetics Act and monitored by the Homeopathic Pharmacopoeia Laboratory, which sets national standards for raw materials, vehicles, products, storage, and packaging.

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    Quality Control in Homoeopathy: Definition

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    11 Isha Chitnis
    222 views3 pages
    Quality control in homeopathy ensures standardized, safe, and effective medicines by maintaining quality throughout the production process from raw materials to finished products. Key aspects of quality control include establishing specifications for materials and products, using qualified personnel and equipment, maintaining suitable environments and infrastructure, and following standard methods of preparation and packaging. In India, quality control is regulated by the Drugs and Cosmetics Act and monitored by the Homeopathic Pharmacopoeia Laboratory, which sets national standards for raw materials, vehicles, products, storage, and packaging.

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    Quality control in homeopathy ensures standardized, safe, and effective medicines by maintaining quality throughout the production process from raw materials to finished products. Key aspects of quality control include establishing specifications for materials and products, using qualified personnel and equipment, maintaining suitable environments and infrastructure, and following standard methods of preparation and packaging. In India, quality control is regulated by the Drugs and Cosmetics Act and monitored by the Homeopathic Pharmacopoeia Laboratory, which sets national standards for raw materials, vehicles, products, storage, and packaging.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    222 views3 pages

    Quality Control in Homoeopathy: Definition

    Uploaded by

    11 Isha Chitnis
    Quality control in homeopathy ensures standardized, safe, and effective medicines by maintaining quality throughout the production process from raw materials to finished products. Key aspects of quality control include establishing specifications for materials and products, using qualified personnel and equipment, maintaining suitable environments and infrastructure, and following standard methods of preparation and packaging. In India, quality control is regulated by the Drugs and Cosmetics Act and monitored by the Homeopathic Pharmacopoeia Laboratory, which sets national standards for raw materials, vehicles, products, storage, and packaging.

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    QUALITY CONTROL IN HOMOEOPATHY

    DEFINITION :-
    a) QUALITY :- IT IS THE STATUS OF A DRUG THAT IS DETERMINED BY IDENTITY, PURITY, CONTENT,
    MANUFACTURING PROCESS AND OTHER CHEMICAL, PHYSICAL , BIOLOGICAL PROPERTIES

    b) QUALITY CONTROL :- IT IS THE TERM THAT REFERS TO THE PROCESSES INVOLVED IN MAINTAINING
    THE QUALITY & VALIDITY OF A MANUFACTURED PRODUCT.

    QUALITY CONTROL IS THE PROCESS IT INCLUDES, “EVERY STEP OF PREPARATION” FROM RAW
    MATERIAL TO FINISHED PRODUCT.
    QUALITY CONTROL PROCESS IS USED FOR STANDARDIZATION OF DRUG SUBSTANCES BY WHICH
    THE QUALITY OF DRUG SUBSTANCE IS ASSESSED.

    AIM :-
    QUALITY CONTROL PROCESS IS USED FOR PROVIDING THE STANDARD MEDICINES TO PATIENTS AND
    TO MAINTAIN EFFICACY (ABILITY) & SAFETY OF HOM. MEDICINE.

    OBJECTIVE OF QUALITY CONTROL :-


    1) FINISHED PRODUCT COMPLIES WITH QUALITY SPECIFICATION (IT IS ACT OF GIVING DETAILS)
    2) FINISHED PRODUCT CONTAINS THE CORRECT INGREDIENTS IN THE CORRECT PROPORTION.
    3) FINISHED PRODUCT MAINTAINS UP TO DATE PURITY.
    4) FINISHED PRODUCT SHOULD BE PREPARED ACCORDING TO THE DIFFERENT OFFICIAL PHARMACOPOEIA.
    5) FINISHED PRODUCT SHOULD PACKED IN PROPER CONTAINER.
    6) FINISHED PRODUCT SHOULD HAVE PROPER LABEL.
    7) FINISHED PRODUCT SHOULD STORED PROPERLY TO MAINTAIN PROPER QUALITY.

    FACTORS OR PARAMETERS FOR QUALITY CONTROL –

    FACTORS WHICH HAVE GREAT ROLE IN MAINTAINING STANDARD QUALITY FROM RAW MATERIAL TO
    FINISHED PRODUCT.

    THESE ARE :–
    1) MATERIALS 4) ENVIRONMENTS
    2) PERSONNEL 5) METHODS
    3) EQUIPMENTS 6) INFRASTRUCTURE

    1) MATERIALS :- QUALITY OF MATERIALS HAS GREAT ROLL TO MAINTAIN THE STANDARD OF MEDICINE,
    MATERIAL SHOULD BE OF STANDARD QUALITY FROM RAW MATERIAL TO FINISHED PRODUCT INCLUDING

    1
    PACKAGING MATERIALS. TO MAINTAIN THE STANDARD OF MEDICINE, PROPER SYSTEM MUST BE APPOINTED
    FOR CONTROL & SUPERVISE THE FOLLOWING:

    A) PURCHASING OF RAW MATERIAL


    B) MAKING OF RECEIPT OF MATERIAL & RAW PRODUCTS
    C) TESTING OF RAW MATERIAL & VEHICLES
    D) STORAGE OF RAW MATERIAL & VEHICLES
    E) COMPANY HAVE ENOUGH MATERIAL FOR MANUFACTURING
    F) PROVIDE RAW MATERIAL FOR MANUFACTURING
    G) MAINTAIN PROPER RECORDS FOR ALL SUCH TRANSACTIONS.

    2) PERSONNEL :-
    - PERSONNEL MEANS WORKER WHO (THE PEOPLES) INVOLVED IN PROCESSING & PACKAGING.
    - PERSONNEL ARE THE MOST SIGNIFICANT FACTORS IN QUALITY CONTROL.
    - EVERY MANUFACTURER MUST HAVE A PROPER SYSTEM OF SELECTION OF PERSONNEL & THEIR
    TRAINING .
    - THE QUALITY OF PRODUCTS ARE DEPENDS ON THE QUALITY OF PERSONNEL.
    - PERSONNEL HAVE THE QUALITIES I.E. INTEGRITY ,INVOLVEMENT, THE TRAINING, EXPERIENCE AND
    THE COMMITMENT OF ALL CONCERNED.

    3) EQUIPMENTS –
    - EQUIPMENTS USED FOR PREPARATION OF MEDICINE ARE IMPORTANT TO MAINTAIN THE QUALITY
    OF THE PRODUCT. EQUIPMENTS MUST BE ACCURATE AND CAPABLE TO MAINTAIN QUALITY OF
    PRODUCT AS PER SPECIFICATIONS.

    4) ENVIRONMENT –
    THE ENVIRONMENTS WHERE THE RAW MATERIALS ARE STORED, PROCESSED AND PACKAGED ARE
    ALSO VERY IMPORTANT BECAUSE ANY CONTAMINATION OF POLLUTANTS MAY DETERIORATE THE
    QUALITY OF PRODUCTS. SO IT SHOULD BE POLLUTION FREE.

    5) METHODS –
    METHODS WHICH ARE USED FOR PREPARATION AND PACKAGING OF MEDICINE HAVE THE
    IMPORTANT CONTRIBUTION TO INCREASE THE STANDARD OR QUALITY OF PRODUCT. SO, MODIFIED
    TECHNIQUES ARE USED FOR PREPARATION OF MEDICINE.

    6) INFRASTRUCTURE – QUALITY OF PRODUCTS DEPENDS ON SUITABLE INFRASTRUCTURE & IT IS


    CONSTRUCTED AS PER GMP RULES.

    2
    QUALITY CONTROL DEPARTMENT :-
    FUNCTION OF QUALITY CONTROL DEPT. IS TO ESTABLISH SPECIFICATION FOR RAW MATERIALS,
    PACKING MATERIALS, INTERMEDIATES AND FINISHED PRODUCTS TO ASSURE THE PROPER QUALITY

    QUALITY CONTROL MONITORING APEX BODY


    [HPL]
    IN INDIA, QUALITY OF HOMOEOPATHIC MEDICINE ARE CONTROLLED BY THE DRUGS & COSMETICS
    ACT 1940
    THE HPL (HOMOEOPATHIC PHARMACOPOEIA LABORATORY) GHAZIABAD, WAS SET UP IN SEPT.
    1975 UNDER MINISTRY OF HEALTH & FAMILY WELFARE, GOV. OF INDIA.
    IT WAS SET UP AS A QUALITY MONITORING APEX BODY. ITS MAIN FUNCTIONS ARE TO SET
    STANDARDS AND TEST OF HOMOEOPATHIC MEDICINE AT NATIONAL LEVEL. IT IS AN APPROVED
    LABORATORY UNDER DRUG & COSMETIC ACT 1940.
    IN HPL STANDARDS OF FOLLOWING SUBSTANCES ARE SEEN:
    - RAW MATERIAL
    - VEHICLE
    - MANUFACTURING PRODUCT
    - FINISHED PRODUCT
    - STORAGE & PACKING

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