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GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING

GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING. Khairul Farihan Kasim School of Bioprocess Engineering UniMAP. GMP Basic requirements. Bioprocess engineering.

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GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING

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  1. GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING Khairul Farihan Kasim School of Bioprocess Engineering UniMAP

  2. GMP Basic requirements

  3. Bioprocess engineering ‘subdisiplin di dalam bioteknologi yang bertanggungjawab untuk menterjemahkan penemuan-penemuan life science kepada hasil yang praktikal, proses, mahupun sistem yang berupaya menyumbang kepada keperluan masyarakat. Ia adalah satu bidang yang kritikal untuk menggerakkan penemuan-penemuan produk berasaskan bio kepada awam’

  4. 'the part of Quality Assurance (QA) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization or product specification.'

  5. 'Engineering for cGMP' those activities performed throughout the project life-cycle, which ensure that it will be easy and natural to operate the completed facility in accordance with current Good Manufacturing Practice.

  6. The 'Project Life-Cycle' from project inception through feasibility studies/conceptual design, engineering, construction, installation, start-up, operation, maintenance to final plant decommissioning or modification.

  7. The minimum requirements by law for the manufacture, processing, packaging, holding or distribution of a material as established in Title 21 of the Code of Federal Regulations.

  8. Types of applicable documentation page 17 • directives, rules, regulations • guides, guidelines, points to consider

  9. General GMP requirement the establishment and maintenance of an effective quality assurance system; control of the process; personnel that are suitably qualified, trained and supervised; premises and equipment that have been located, designed, installed, operated and maintained to suit intended operations;

  10. maintenance of adequate records of all aspects of the process so that in the event of a problem being identified, an investigation can trace the complete history of the process, including how, when, and where it was produced, under what conditions and by whom (i.e. an audit trail); the prevention of contamination from any source, in particular from components, environment, premises and equipment by the use of suitable premises and equipment and through standard operating procedures.

  11. Project assessment to determine applicable standards page 20 - 22 stage of product development; stage of production; category of the product and production processes employed; facility location and location of the markets that the facility will serve.

  12. page 22 process issues layout issues automation strategy issues flow issues regulatory issues validation strategy issues

  13. page 23-34 facilities and environment; services and utilities; personnel flows; material flows; equipment flows; equipment design; computerized systems; maintenance and services; waste management; procedure and documentation.

  14. Find out for next class!!! Title 21 of the Code of Federal Regulations. Malaysia regulatory

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