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    Revised Schedule M

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    pandeygajendra2907
    Revised Schedule M

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

    Revised Schedule M

    Uploaded by

    pandeygajendra2907
    269 views37 pages
    Revised Schedule M

    Original Title

    Revised schedule M PPT

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    © © All Rights Reserved

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    Revised Schedule M

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    269 views37 pages

    Revised Schedule M

    Uploaded by

    pandeygajendra2907
    Revised Schedule M

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 37

    REVISED

    SCHEDULE M
    GMP: Good Manufacturing
    Practices
    Schedule A: Contains various forms and formats of letters for
    applications of licensing etc.
    Schedule B: Contains fees structure for government-run labs.
    Schedule C: Contains various biological products and their regulation.
    Examples: serums, adrenaline, vitamins etc.
    Schedule D: List of drugs exempted from the provision of import of drugs
    Schedule E: Contains various poisons and their regulation. Examples:
    Sarpa Visha (Snake venom), Parada (Mercury) etc.
    Schedule F: This contains regulations and standards for running a blood
    bank.
    •
    •
    •
    •
    •
    •
    •
    •
    HISTORY
    • GMP system is introduced in year 1988
    • First revision to schedule M was done in 2005
    • Current schedule M was published in OCTOBER
    2018
    • Final notification of SCHEDULE M is published
    on 28.12.2023 though G.S.R 922(E)
    Old Schedule M
    • Schedule M of 2001 is divided in two parts.

    • Part I : General Manufacturing Practices for Premises and Materials


    Each section is explained with certain requirements but not in specific details.
    • Subparts are Part IA to Part IF
    -Deals with GMP for Specific product Types.
    • Part II- Requirements of Plant and Equipment

    1. External Preparations 2. Oral Liquid Preparations


    3. Tablets 4. Powders
    5. Capsules 6. Surgical Dressing
    7. Ophthalmic Preparations 8.Pressurizes and
    suppositories
    9. Inhalers and vitrallae 10. Parenteral Preparations
    11. Repacking of Drugs &
    Pharmaceutical Chemicals
    OTHER GMP GUIDELINES
    • USDA 21 CFR part 210- CGMP in
    manufacturing,processing,packaging/holding of drugs.
    • USDA 21 CFR part 211-CGMP for finished pharmaceuticals.
    • PICS-PE009 Guide to GMP for Medicinal Products FEB 2012
    • EMA- Guideline for manufacture of finished dosage form-
    245074/2015, JULY 2017.
    WHY GMP?

    • Regulatory request
    • Patient’s trust
    • Manufacture pharmaceutical
    product quality of intended quality
    • To set minimum uniform standard
    for manufacturing of products.
    Time Line for implementation
    • Time line for implementation of revised schedule M is based
    on the turnover of company
    • 6 months for company having turnover of more than 250
    crores
    • 12 months for company having turnover of less than 250
    crores.
    Out line of revised schedule M
    • At per with international GMP guidelines.
    • Close to GMP guidance of PIC's PE- 009.
    • It contains 13 different chapters.
    • No change in area required for various sections.
    Title of chapters of Schedule M
    • GMPof pharmaceutical : main principles.
    (Appendix - 1 , site master file)
    • Specific requirements for manufacture of
    sterile products, parenteral preparations
    (SVP & LVP) & sterile opthalmic products.
    • Requirments for manufacturing of
    pharmaceutical products containing
    hazardous substances such as sex
    hormones, steroids & cytotoxic substances.
    Title of chapters of Schedule M
    • Specific requirements for manufacturing of
    biological products.
    • Specific requirements for manufacturing of
    radio pharmaceutical products.
    • Specific requirements for manufacturing of
    phytopharmaceuticals.
    • Specific requirements for manufacturing
    products for investigation pharmaceutical
    products for clinical trials in human.
    Title of chapters of Schedule M
    • Specific requirements for manufacturing of oral
    solid dosage forms (tablets & capsules).
    • Specific requirements for manufacturing of oral
    liquids.
    • Specific requirements for manufacturing of
    topical products.
    • Specific requirements for manufacturing of
    Metered dose inhalers.
    • Specific requirements for manufacturing of API.
    • Requirments of plant & equipments.
    Differences in revised schedule-M
    Guidance for manufacturing of following is Added:-
    • Hormones, steroids & cytotoxic
    • Biological parents.
    • Radio pharmaceuticals products.
    • Phytopharmaceutical products.
    • Investigational pharmaceutical products of
    humans.
    Differences in revised schedule-M
    • One full chapter of pharmaceutical quality system
    is introduced.
    • Chapter of Quality Risk Management is included.
    • In sanitization & personnel hygiene, equipment
    hygiene is included.
    • In complaints & adverse reactions the
    requirements of pharmacovigilance for each
    company.
    • Recalled activities shall be informed to regulators.
    Differences in revised schedule-M
    • Personnel qualification for the key person is
    specified.
    • A full chapter for Change control is in place.
    • Computer software & hardware shall be covered in
    change control.
    • A chapter on loan license, contract manufacturing &
    contract analysis is included.
    • Along with self inspection, quality audit & is also
    included.
    • Frequency for self inspection is specified as yearly.
    Differences in revised schedule-M
    • In personnel, individual responsibilities of Quality &
    production as well as joint responsibilities are
    mentioned in details.
    • Environmental conditions shall be maintained in
    working as well as non working conditions.
    • Preferably closed system shall be used for processing
    of the batches.
    • Only the materials released by QC & which are in shelf
    life shall be used. 14.14)
    • One chapter for reference standard is included & it is
    specified that it shall be procured from IPC.
    • Drug act & IP & other books shall be available.
    IP Version’s
    shelf life
    Differences in revised schedule-M
    • Retention samples of API shall be stored one
    year beyond expiry of corresponding FG.
    • Retention samples of excipients shall be stored
    for 2 years other than solvents, gases, & water.
    • GMP related computerized system shall be
    validated.
    • It shall prevent unauthorized data change.
    • Record of changes shall be available.
    • Changes to the computerized system shall be
    done through change management system.
    Differences in revised schedule-M
    • Backups of the system shall be taken
    periodically.
    • Sufficient data protection shall be in place in
    case of system crash.
    • Continuous particle monitoring for class A &
    class B shall be done.
    • Class D active air sampling limit is changed
    from 500 to 200.
    • Plate exposure time is increased from 2 hours
    to 4 hours.
    Prepared By:
    Jyoti Subhash Kapse

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