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    Anvisa Checklist

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    Rakesh
    The document outlines a proposed audit schedule for a company over 5 days. It details the activities and systems that will be inspected each day, including engineering/utilities systems, warehouse and production areas, quality control laboratories and documentation, equipment and supplier qualification, and training programs. The schedule includes tours, reviews of procedures, specifications and records for areas like utilities, HVAC, water systems, storage conditions, batch records, process validation, and complaint handling. The audit aims to evaluate the company's facilities, processes and quality systems over the week.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Anvisa Checklist

    Uploaded by

    Rakesh
    887 views4 pages
    The document outlines a proposed audit schedule for a company over 5 days. It details the activities and systems that will be inspected each day, including engineering/utilities systems, warehouse and production areas, quality control laboratories and documentation, equipment and supplier qualification, and training programs. The schedule includes tours, reviews of procedures, specifications and records for areas like utilities, HVAC, water systems, storage conditions, batch records, process validation, and complaint handling. The audit aims to evaluate the company's facilities, processes and quality systems over the week.

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    Auditing

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    Anvisa checklist

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    The document outlines a proposed audit schedule for a company over 5 days. It details the activities and systems that will be inspected each day, including engineering/utilities systems, warehouse and production areas, quality control laboratories and documentation, equipment and supplier qualification, and training programs. The schedule includes tours, reviews of procedures, specifications and records for areas like utilities, HVAC, water systems, storage conditions, batch records, process validation, and complaint handling. The audit aims to evaluate the company's facilities, processes and quality systems over the week.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    887 views4 pages

    Anvisa Checklist

    Uploaded by

    Rakesh
    The document outlines a proposed audit schedule for a company over 5 days. It details the activities and systems that will be inspected each day, including engineering/utilities systems, warehouse and production areas, quality control laboratories and documentation, equipment and supplier qualification, and training programs. The schedule includes tours, reviews of procedures, specifications and records for areas like utilities, HVAC, water systems, storage conditions, batch records, process validation, and complaint handling. The audit aims to evaluate the company's facilities, processes and quality systems over the week.

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    National Health Surveillance Agency

    General Office of Inspection and Control of Inputs, Drugs and Products

    PROPOSED AUDIT SCHEDULE

    1. INSPECTION DETAILS

    Company
    Audit Location
    Inspection date
    Scope
    Inspectors (ANVISA –
    Brazilian authorities)

    2. INSPECTION SCHEDULE
    MONDAY
    Schedule Activities/program
    09:00 – 12:00  Official introduction (opening meeting)
     General site overview: history, buildings and respective uses,
    organogram, number and graduation of employees and other
    relevant information.
     Organization Chart
     Periodic Product Review – SOP and records
     Computer Systems: list with softwares names, uses and
    categories.

    List of all products with active ingredients manufactured. A print copy will
    be requested.

    List of all batches manufactured in the last 12 months for the products
    related with inspection scope. During the inspection some batch records
    will be requested for verification.
    12:00 – 13:00 Lunch
    13:00 – 17:00 Engineering / Utilities
     Utility systems.
    1. Purified Water System:
    a) Diagram showing the purification steps and distribution system.
    b) Adopted specification for PW.
    c) System validation.
    d) Daily Record Books for operational parameters.
    e) Routine monitoring program for chemical and micro tests
    together with the last three month results.
    f) Sanitization Procedure and Records.
    g) Preventive Maintenance procedures.
    h) Last annual review and trend analysis.
    2. SOP’s related to activities
    3. Air treatment Systems
    a) Diagram showing the pressure differential between surrounding
    areas (records will be requested), AHU distribution and room
    classification based in the number of non-viable particles.
    b) Preventive maintenance procedures.
    c) SOP’s related to activities

    1
    National Health Surveillance Agency
    General Office of Inspection and Control of Inputs, Drugs and Products

    TUESDAY
    Schedule Activities/program
    09:00 – 12:00 Utilities

     Validation / revalidation of the utilities systems: list of systems


    validation historic, including changes. Some reports/documents
    will be requested.
     HVAC: environmental monitoring (frequencies, sampling points,
    sampling techniques, testing, specifications and evaluation).
    Trend analyses. Periodical Re-qualification approach and
    records.
     Water system documentation: specifications of the different
    water grades used by the company. Routine monitoring
    procedure. Trend analysis. Sanitization procedures and records.

    12:00 – 13:00 Lunch


    13:00 – 17:00 Warehouse and Production
    Production

     Production flow: Diagram containing all production steps


    (informing equipments and rooms’ tags/id, manufacturing and
    packaging areas). Diagrams of personnel and material (raw
    material, intermediates, clean and dirty equipments) flows in
    production areas. If applicable, list of active substances handled
    in the non-dedicated areas. Procedures/lists with all IPC (in
    process controls) and holding times for intermediaries products.

    Warehouse
     Tour: warehouses (storage areas, storage areas, sampling
    rooms and dispensing areas).
     Storage conditions: procedure and monitoring records obtained
    last year, temperature mapping studies, qualification of the cold
    rooms/ chambers.
     Rejected and returned products storage areas and handling of
    these products.
     Sampling / dispensing documentation (procedures and records)
     Receipt procedures and records
     Procedures and sampling plans
     SOP´s related to activities.

    2
    National Health Surveillance Agency
    General Office of Inspection and Control of Inputs, Drugs and Products

    WEDNESDAY
    Schedule Activities/program
    09:00 – 12:00 Production areas

     Tour.
     Change Control procedures (Procedure and list of changes
    proposed 2012/2013)
     Handling of process deviation. (Procedure + list of deviations for
    2011-2012)
    12:00 – 13:00 Lunch
    13:00 – 17:00 Quality Assurance
     Validation Master Plan
     Cleaning Validation.
     Equipment chain for the products in the scope containing
    the tag numbers of each equipment.
     Type of Cleaning Validation Approach used by the
    company.
     Determination of Acceptance Criteria.
     Determination of Sampling Locations and sampling
    techniques used (Recovery Studies).
     Evaluation for the dirty and clean equipment holding
    times.
     Results evaluation and discussion
     Process Validation Analysis.
     Strategy used by the company to perform the process
    validation.
     Process validation historic for the different products.
     Process Validation Protocols and Reports will be
    requested.
    Batch records.

    THURSDAY
    Time Activities
    09:00 - 12:00 Quality Control

     Starting materials, intermediary products and finished products


    specifications.
     Tour: Quality control laboratories (Physicochemical and
    Microbiological laboratories).
     Procedures related to the activities.

    12:00 – 13:00 Lunch


    13:00 – 17:00 Quality Control
     OOS Procedure (physicochemical and microbiological).
     Retention samples management (documents and visit to
    retention room).
     Stability studies (procedure and list of the batches under stability
    study).
    3
    National Health Surveillance Agency
    General Office of Inspection and Control of Inputs, Drugs and Products

    Quality Assurance
     Documentation management (Procedures related with
    organization, creation, review, distribution, approval and
    withdraw of procedures)
     Self- Inspection (Procedure and Schedule 2013)

    FRIDAY
    Time Activities
    09:00 - 12:00 Quality Assurance
     Equipment qualification and maintenance.
     Release of Finish Products. (Procedure)
     Supplier qualification.
     Complaint Handling
     Training program, procedures and records
     Pest Control
     Recall System
    12:00 – 13:00 Lunch
    13:00 – 15:00 Final Meeting/ Close Out

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