GIU Pharmaceutical Engineering & Biotechnology Lecture Notes PDF

Pharmaceutical Engineering and Biotechnology Department of Pharmaceutical Technology Good manufacturing Practice & Quality Management System...

Pharmaceutical Engineering and Biotechnology Department of Pharmaceutical Technology Good manufacturing Practice & Quality Management System (PHEN 502) Lecture 3: GMP; Personnel management Course Instructor: Dr. Shahir Aziz Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 1 Outline Introduction: Recall - Manufacturing process flow Personnel: General guidelines Safety HACCP OSHA Training Competency based training & Qualifications Hygiene Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 2 Manufacturing process – Flow through Layout Introduction Recall Pharmaceutical Factory Layout Example 3rd Unit for Liquid E Administrative Offices R&D Production x t e Intermediate products r 2nd Unit for Special Products / Biologics / n Quality Control Antibiotics…etc. a Raw Material Finished goods Packaging l R Approved Final In process Warehouse Coating Tablet Compression o Product Quarantine a GMP Solid Production Unit Shipping Receiving d Area Area Receiving Approved Material Dispensing Granulation Quarantine warehouse External Road Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 3 3 Heating, ventilation and air-conditioning (HVAC) Premises Recall Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 4 Heating, ventilation and air-conditioning (HVAC) Premises Recall The degree to which air is filtered plays an important role in the prevention of contamination and the control of cross contamination. The process core is regarded as the most controlled clean zone which is protected by being surrounded by clean areas of a lower classification. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 5 Definition and general guidelines Personnel GMP rely upon people, for this reason there must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible. Individual responsibilities should be clearly defined and understood by the persons concerned and recorded as written descriptions. Personnel Qualified/ Safety Trained Hygiene Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 6 Personnel Safety Personnel The manufacturer should assure the safety of workers and take the necessary measures to prevent pollution of the external environment. Under GMP, all necessary resources are provided such as appropriately qualified and trained personnel in addition to the safe working environment. But GMP does not cover the full safety of the personnel engaged in manufacturing process. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 7 Personnel Safety Personnel Accordingly, Other guidelines has to be followed: 1. The application of hazard analysis and critical control point (HACCP) methodology 2. OSHA’s Regulations and standards Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 8 Personnel Safety - HACCP Personnel  HACCP is a systematic method for the identification, assessment and control of safety hazards. Such hazards are defined as biological, chemical, or physical agents or operations that are likely to cause illness or injury if not controlled.  Before HACCP is applied to any sector, that sector should be operating in accordance with the principles of good practices and the relevant legislation (such as GMP and GLP).  Management commitment is necessary if an effective HACCP system is to be implemented and should be applied to each specific operation separately.  A team is assembled from the Risk analysis unit whose members should have specific knowledge and expertise regarding the product and process to apply a suitable HACCP plan Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 9 Personnel Safety - HACCP Personnel Safety The HACCP system is based on the risk management principles; Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 10 Personnel Safety - OSHA Personnel Overview: OSHA is part of the Unites states department of Labor. It has identified worker exposure to hazardous drugs as a problem of increasing health concern. Preparation, administration, manufacturing, and disposal of hazardous medications may expose hundreds of thousands of workers, principally in healthcare facilities and the pharmaceutical industry, to potentially significant workplace levels of these chemicals. It sets obligatory regulations and standards, in addition to conducting trainings and audits on the standards compliance. Regulations for Controlling Occupational Exposure to Hazardous Drugs: https://www.osha.gov/hazardous-drugs/controlling-occex Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 11 Personnel Qualification and Training Personnel 1. Adequate number of personnel with the necessary qualifications and practical experience.  Each person engaged in the manufacture, processing, packing or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. 2. Recorded in written descriptions  All responsible staff should have their specific duties recorded to get adequate authority to carry out their responsibilities. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 12 Personnel Qualification and Training Personnel 3. All personnel should be aware of the principles of GMP  By receiving initial and continuing training, including hygiene instructions, relevant to their needs. 4. Prevent unauthorized people  From entering production, storage and quality control areas. Personnel who do not work in these areas should not use them as a passageway. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 13 Personnel Qualification and Training Personnel What Is Competency - Based Training? Example: a competency - based program for tablet operators may be designed to ensure that operators can follow all steps in equipment start-up, operation, shut- down, and troubleshooting. The test to ensure that trainees acquired those competencies during training might include labeling a diagram of the equipment and performing a demonstration of how to start up, operate, shut down, and troubleshoot the equipment. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 14 Personnel Qualification and Training Personnel Competency Framework Design The goal of competency-based training and assessment is to produce a competent workforce by providing focused training. It does so by identifying key competencies that need to be achieved, determining the most effective way of achieving them and establishing valid and reliable assessment tools to evaluate their achievement. Competency – Based training and assessment workflow: Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 15 Personnel Qualification and Training Personnel Developing a training plan: Strategy to ensure training compliance Training Organization setting philosophy and mission Training Record keeping Training Program Listing all personnel to be trained Training Plan Training Implementation develop Training Development Designing implementation schedule and failure competency – based training response process Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 16 Personnel Hygiene Personnel 1. All personnel, prior to and during employment, as appropriate, should undergo health examinations. 2. Periodic health examination should be conducted 3. All personnel should be trained in the practices of personal hygiene.  In particular, personnel should be instructed to wash their hands before entering production areas (Advisory signs to this effect should be posted and instructions observed). 4. Any person shown at any time to have an apparent illness or open lesions should not be allowed to handle starting materials, packaging materials, in-process materials or drug products until the condition is no longer judged to be a risk. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 17 Personnel Hygiene Personnel 4. Direct contact must be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product. 5. To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized. 6. Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material and personal medicines should not be permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 18 Personnel Hygiene Personnel Personal hygiene procedures including the use of protective clothing should apply to all personal entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors’ employees, visitors, senior managers, and inspectors. 4) Aseptic Gowning for the Cleanroom: https://www.youtube.com/ watch?v=uvhaPu1-fdE Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 19 What do you observe ? Premises & Personnel Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 20 Applying GMP Operator protection at weighing Operator subject to powder inhalation due station – Unidirectional airflow to obstruction in return air Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 21 References 1. EUROPEAN COMMISSION - HEALTH AND CONSUMERS DIRECTORATE-GENERAL. 2012. The Rules Governing Medicinal Products in the European Union. Brussels : EUROPEAN COMMISSION, 2012. Ref. Ares(2012)778531 - 28/06/2012. 2. GAD, SHAYNE COX. 2008. PHARMACEUTICAL MANUFACTURING HANDBOOK; Regulations and Quality. New Jersey : John Wiley & Sons, Inc., 2008. ISBN: 978-0-470-25959-7. 3. World Health Organization. 2007. Quality assurance of pharmaceuticals : a compendium of guidelines and related materials. Geneva : WHO Press, 2007. ISBN 92 4 154708 1. 4. World Health Organization. 2009. Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development -. Geneva : WHO Library, 2009. ISBN 978 92 4 154755 0. 5. U.S. Department of Health and Human Services Food and Drug Administration. 2009. Guidance for Industry Q10 Pharmaceutical Quality System. Silver Spring : Food and Drug Administration (FDA), 2009. Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 22  “You have power over your mind — not outside events. Realize this, and you will find strength.” Marcus Aurelius Roman emperor (120 to 180 AD) THANK YOU Dr. Shahir Aziz – GMP & QMS course (PHEN 502) – Winter 2024 23