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  • About Patel Hardware & Sanitary

    Aim / Vision / Mission

    Vision

    For us at Marck Biosciences, Innovision is a dynamic principle of order, manifesting itself in change, not in rigidity. We believe, because of Innovision, we have an organization that undergoes change without becoming chaotic, an organization that can re-engineer itself to remain relevant in a continuously dynamic environment.

    Memberships / Affiliations

    • ISO : 9001 – 2000

    • ISO : 13485

    • ISO 14001 : 2004

    • OHSAS 18001 : 2007
    • WHO – GMP

    • ANVISA (Brazil)

    • The National Pharmaceutical Control Bureau (NPCB) (Malaysia - a PIC Member)

    • CE – Mark (for Eye Wash Solution)

    • Australian Register of Therapeutic Goods (Normal Saline)

    • The National Authority of Uganda

    • The Pharmacy Board of Tanzania

    • The Ministry of Health (Ukraine)

    • The Pharmacy Board (Sudan)

    • Food & Drug Board (Ghana)

    • Medicines Control Authority (Zimbabwe)

    • Ministry of Health & Population Supreme Board for Drugs & Medical Appliances (Yemen)

    • Drug Administration & Control Authority of Ethiopia (SVP Facility)

    • Bureau of Food & Drug (Philippines)

    • Food & Drug Board of Authority (Myanmar)

    • Food & Drug Administration (Thailand)

    • Ministry of Vietnam

    Quality Policy / Processes

    Quality Policy

    A robust quality system facilitates both a Good Manufacturing Practice & a Good Business Practice. If the quality system is efficiently developed and effectively managed, it leads to consistent predictable outcome. This ensures that pharmaceuticals are safe, effective and available for the consumer.

    Being a cGMP facility, we strive continuously to determine proper implementation of good manufacturing systems & regulations. Our ceaseless efforts are directed towards maintaining highest quality standards as well as we look forward to enhance our facilities, upgrade our technology & install new instruments as per 21 CFR.
    Quality Control

    Our Quality Control involves;

    Assessing the suitability of Incoming Components, Closure Labeling, In Process Materials & Finished Products
    Evaluating the performance of the manufacturing process to ensure adherence to proper specification & limits
    Determining the acceptability of each batch for release
    To carry out the above activities at Marck, we have developed a state-of-art & most sophisticated quality control laboratory equipped with instruments like;

    TOC Analyzer
    HPLC (High Pressure Liquid Chromatography)
    FTIR (Fourier Transfer Infra Red Spectroscopy)
    UV – Visible Spectrophotometer
    Flame Photometer
    Polari meter
    Liquid Particulate Counter
    Stability Chamber
    Air Particulate Counter
    Quantitative Air Sampler
    Pico pHmeter
    Quality Assurance

    Our Quality Assurance involves;

    Review & Approval of all procedures related to production & maintenance
    Review of Associated Records
    Auditing & Performing/Evaluating Trend Analysis

    An ISO : 9001 – 2000 certified company

    Infrastructure

    Infrastructure

    To keep the pace with today’s requirements of the pharmaceutical industry, we have adopted the most modern & sophisticated Aseptic Blow – Fill – Seal technology. ISO certified & cGMP compliant facilities of Marck can handle manufacturing & packaging of Sterile Liquid Parenterals from 5 ml to 1000 ml.

    Spread over 25 acres of land area near Kheda (Ahmedabad), our manufacturing operations are supported by most modern equipments, state – of – art Quality Control and F & D capabilities.

    With a total construction area of 19,000 sq mts, our state – of – art manufacturing complex with following features gives us a competitive edge:

    • Aseptic Blow Fill Seal technology from Renowned manufacturer’s like Weiler Eng.(USA) and Rommelag (Germany) with Nitrogen blowing facility for sensitive drugs manufacturing

    • Clean rooms are made-up of prefabricated panels from Clestra France

    • Manufacturing is in Grade “B” area and all vessels have chilling and sterilizing facility to facilitate manufacturing of various combinations of drug in clear as well as suspension form

    • Filling is under grade “A” area having continuous particle monitoring with a background of grade “C”

    • UPS for filling LFR on all BFS machines

    • Terminal Sterilization of products by ‘Super Heated Water Spray Sterilizer”

    • Entire process is controlled by “SCADA” system

    • Automated packing lines having 100% leak detection system

    We have most modern systems to support our entire manufacturing process:

    WATER SYSTEMS

    • Double pass RO system coupled with EDI+UV and UF for generation of high grade purified water followed by distillation process for generation of SWFI

    • Continuous recording system for WFI temperature, conductivity and velocity in loop

    ENVIRONMENTAL CONTROL SYSTEMS

    • Separate AHU system for each of the activities

    • All classified rooms entry has bio-metric access control. All man and material entries to the plants are interlocked and material entries are sealed with dynamic LAF

    To,Patel Hardware & Sanitary

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