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    SK Suraj, Quality Assurance, Roll No - 38301921059

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    Sk Suraj
    Finally, the document provides more details on the specific responsibilities of heads of production, quality control, and the authorized person. It describes their roles in activities such as facility and equipment maintenance, process validation, approving materials, and supervising quality audits.

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    SK Suraj, Quality Assurance, Roll No - 38301921059

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    Sk Suraj
    8 views7 pages
    Finally, the document provides more details on the specific responsibilities of heads of production, quality control, and the authorized person. It describes their roles in activities such as facility and equipment maintenance, process validation, approving materials, and supervising quality audits.

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    Quality assurance

    Original Title

    Sk Suraj , Quality Assurance , Roll No - 38301921059

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    Finally, the document provides more details on the specific responsibilities of heads of production, quality control, and the authorized person. It describes their roles in activities such as facility and equipment maintenance, process validation, approving materials, and supervising quality audits.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views7 pages

    SK Suraj, Quality Assurance, Roll No - 38301921059

    Uploaded by

    Sk Suraj
    Finally, the document provides more details on the specific responsibilities of heads of production, quality control, and the authorized person. It describes their roles in activities such as facility and equipment maintenance, process validation, approving materials, and supervising quality audits.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 7

    ORGANIZATION & PERSONAL

    RESPONSIBILITYS FOR INDUSTRY

    NAME – SK SURAJ
    ROLL – 38301921059
    REG.NO – 213830201910010
    SUBJECT – QUALITY ASSURANCE
    PAPER CODE – PT611
    STREAM- B. PHARM 3RD YEAR, 6TH SEM
    CA2 EXAM
    SEACOM PHARMACY COLLEGE
    Definition:- Quality assurance (QA) is utmost important for the growth and
    development of any organization. Without appropriate quality assurance
    especially in pharmaceutical industry, it is near to impossible to guarantee the
    quality and safety of the products. Although, quality assurance is the
    responsibility of every person involved in the pharmaceutical industry top
    executives and senior members are considered more important to provide
    training and adopt an environment whereas the primary focus is to attain the
    standards of quality. QA an outcome of teamwork. QA is an integral part of
    pharmaceutical industry and management executives should understand the
    importance of maintaining quality assurance
    The basic job of management is the effective utilization of the people, which
    they have. To achieve from organizational objectives. Without human efforts, no
    organization can achieve their objectives. An industry must have a quality
    manual to maintain and improve its standard and quality.

    General responsibilities of the concerned personnel


    o Sampling procedures and the details of the equipments employed in the
    procedu
    o Testing and release of components.
    o Reserve samples.
    o Periodic inspection of stocks.
    o Labels and other printed materials.
    o Vendor selection and development.
    o Research and development department.
    o Stability study program quality manual.
    o Manufacturing Operations and Control:

    • Master Formula Files.


    • Weighing and Dispensing.
    • Processing.
    • In-process Control.
    • Specific Instructions for Sterile Products.
    • Calibration Program & Validation.
    STRUCTURE OF THE ORGANIZATION

    1. Quality control- all inspection and testing

    2. Quality assurance- all systems and procedures including batch


    review and audit Main responsibility of QA and QC Departments is
    to test and control the ingredient record, equipment, reagents:

    ➢ ➤ Active pharmaceutical ingredient (API).

    ➢ ➤ Analytical test report.

    ➢ ➤ Certified reference material.

    ➢ ➤ Calibration Certificate of Analysis


    Objectives of personnel management are as follows:

    ▪ To review general issues related to personnel.


    ▪ To review requirements for key personnel
    ▪ To review the training of personnel.
    ▪ To consider some specific issues.

    Key Personnel:
    Key personnels are considered those persons in the organization, who have
    direct impact on the working of the organization and quality of the product
    produced.

    There are six different key personnel:

    1. Head of production department.


    2. Head of Quality Control department.
    3. Head of Quality Assurance Department.
    4. Authorized person.
    5. Managing director.
    6. Head of sales and distribution department.

    Key personnel (which normally should be full-time) positions include:

    ✓ Authorized person.
    ✓ Head of Production.
    ✓ Head of Quality Control.
    Personnel Shared Responsibilities:

    I. Heads of the department of Production and Quality Control may share or


    jointly exercise some responsibilities associated with the quality of
    product. These responsibilities are shared to perform several functions
    involved in the process of production and quality control.

    II. Mutual understanding on standard operating procedures (SOPs) and other


    documents including amendments.

    III. Maintenance and management of manufacturing conditions in production


    plant as well as cleanliness in the plant.

    IV. Process validation and calibration are the integrated process in the
    process of production and quality control. The process validation and
    calibration can be jointly shared by the production and quality control
    department. The

    V. Heads of the department of Production and Quality Control can also share
    responsibility associated with the training and other processes associated
    with the application and implementation of principles of QA

    VI. Approval and monitoring of suppliers and contract acceptors can be


    jointly exercised for both the department.

    VII. Description and monitoring of storage conditions for materials and


    products. Performing and evaluating in-process controls.

    VIII. Retention of records: This can be another area where two departments can
    share the responsibilities.
    Head of Production: Responsibilities

    i. It is the responsibility of the production head to maintain a suitable


    environment for the production and storage of the finished products as
    well as maintenance of the proper documentation related with the
    production. The premises, equipment should be properly checked and
    maintained as per the regulatory guidelines

    ii. The instructions related to the production should be well written and
    communicated to the concerned staff and implementation of production
    instructions, in-process QC and ensure strict implementation should be
    checked.

    iii. The validation of the process and calibration of the equipments should be
    performed o the regular intervals and records should be maintained
    properly, and reports are made available.

    iv. Head of the production department should ensure initial and continuous
    training a production personnel on regular intervals. The latest updates
    should be implemented Ensures that production records are evaluated and
    signed by designated person.

    Head of Quality Control: Responsibilities

    A. Approval or rejection of materials: It is the responsibility of the head of


    quality control, to inspect the quality of packing material, intermediates,
    bulk, semi-finished and finished products as per the specifications
    required by the regulatory agency.
    B. Evaluation of batch records: All the records related to the quality should
    be evaluated on the regular basis.

    C. Approval of quality control procedures, eg. Sampling and testing:


    specifications of Personnel

    D. All the contracts should be monitored and approved by the head of


    quality control.

    E. The premises used for the production, maintenance for the quality control
    should be checked by the quality control department. Ensures validation
    (including analytical procedure validation) and calibration of control
    department.

    Authorized person: Responsibilities

    a. Compliance with technical and regulatory requirements for the approval


    of the products and approval of release of finished product for sale.

    b. Development of quality manual and implementation of quality system in


    organization.

    c. Supervision of self-inspections, quality audits and participation in


    external audits and vendor audits and validation programs.

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