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    GMP Training

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    Prince Moni
    The document discusses three main elements of GMP training: 1) Introductory training for new employees to learn about company policies and the social significance of pharmaceutical products. 2) GMP training covering topics like quality assurance, documentation, hygiene practices. 3) Specific skills training which involves hands-on demonstration and practice. Effectiveness of training should be assessed during and after sessions. Retraining is necessary when assessments or changes indicate a need. Detailed training records should be maintained for employees and departments.

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    GMP Training

    Uploaded by

    Prince Moni
    687 views3 pages
    The document discusses three main elements of GMP training: 1) Introductory training for new employees to learn about company policies and the social significance of pharmaceutical products. 2) GMP training covering topics like quality assurance, documentation, hygiene practices. 3) Specific skills training which involves hands-on demonstration and practice. Effectiveness of training should be assessed during and after sessions. Retraining is necessary when assessments or changes indicate a need. Detailed training records should be maintained for employees and departments.

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    gmp training

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    The document discusses three main elements of GMP training: 1) Introductory training for new employees to learn about company policies and the social significance of pharmaceutical products. 2) GMP training covering topics like quality assurance, documentation, hygiene practices. 3) Specific skills training which involves hands-on demonstration and practice. Effectiveness of training should be assessed during and after sessions. Retraining is necessary when assessments or changes indicate a need. Detailed training records should be maintained for employees and departments.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    687 views3 pages

    GMP Training

    Uploaded by

    Prince Moni
    The document discusses three main elements of GMP training: 1) Introductory training for new employees to learn about company policies and the social significance of pharmaceutical products. 2) GMP training covering topics like quality assurance, documentation, hygiene practices. 3) Specific skills training which involves hands-on demonstration and practice. Effectiveness of training should be assessed during and after sessions. Retraining is necessary when assessments or changes indicate a need. Detailed training records should be maintained for employees and departments.

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    The key takeaways are that training is important for all employees in a pharmaceutical company and should cover background information, GMP practices, and specific skills. Training helps motivate employees and improves performance when they understand how their work impacts patients.

    The three basic training elements discussed are introductory/background training for new employees, GMP training including hygienic practices, and specific skills training.

    Some of the topics that should be considered for GMP training are the history of medicine, the healthcare industry and company's role, benefits and risks of medicines, quality assurance/control, documentation systems, cleanliness and hygiene, legislation and inspections.

    GMP Training

    The Major Training Elements


    The areas in which training needs to be given may be considered as forming three basic training
    elements:1.Introductory, background (induction or orientation) training for newemployees2.GMP
    training, including training in hygienic practices3 . S p e c i fi c s k i l l s t r a i n i n g No one of these
    elements should be neglected.
    Background Training
    All new employees, in any job, in any industry, need to acquire a certain basic knowledge of the
    company in which they will work; its pay, personnel, and promotion policies; its physical layout (they
    need to find their way around); its supervisory and management structure; and so on. In the
    pharmaceutical industry, it is also important that employees are aware of the ethical, social, and
    legalsignificance of the company’s activities. The task of impressing upon employees the importance
    of the end product, and of the
    quality
    of the end product, should be relatively easy, since treatment by medicine is an inherently human-
    interest subject. Every opportunity should be taken to stress that the company is making medicines for
    patients. Not only is it a powerful factor in employee motivation, it is indisputable that people learn
    quicker and better, and function more effectively, when they can relate what they are learning and
    what they are doing to a wider context. The employee in the pharmaceutical industry needs to be able
    to relate his or her job not only to the work of the factory as a whole, but also to the social — the
    human — significance of what their company is doing. This is not just high-minded ethics. It is also,
    like so much of GMP, good hard-headed business sense

    GMP Training
    GMP training is necessary for all Production and Quality Control workers, and also for any other
    personnel whose duties take them into production or control areas, or in any way bear upon the nature and quality of a
    company’s products. To provide a context, to stimulate interest, and to supply motivation, this training
    should be related to the general background of the history and use of medicines and their role in
    society, briefly and simply explained. The following is a brief checklist of topics that should be
    considered:

    Brief history of medicine — the “therapeutic revolution”


    Background of the healthcare industry and the company’s place in it
    Benefits and risks of modern medicines
    Cost of medicines: R & D

    The need for GMP


    Quality Assurance and Quality Control
    Pharmaceutical dosage-forms and packs
    Company product lines
    Problems of faulty batches and recall
    Theneedandreasons fordocumentation, records, andwritten procedures
    The company’s documentation system — and the importance of abiding by it
    Cleanliness, hygiene, and simple microbiology
    Personal hygiene

    Plant and equipment cleaning methods and schedules

    Nature and problems of microorganisms

    Microbial and cross contamination

    Clothing

    Effects of legislation, regulation, and inspection

    The overall company manufacturing and control cycle

    The emphasis placed on different topics may vary in different organizations. Always, the main
    motivating thrust should be that the reason for being GMP-minded is for the sake of the sick patient
    who needs the products. A secondary motive can be the fact that if the company produces significantly
    defective goodsit will rapidly cease to be able to pay employees. While staff must obviously havean
    understanding of relevant statutory and regulatory matters, and of the need toabide by the law, an
    approach based solely on “we have a quality system, and we follow GMP, and we do it this way
    because the man from the Regulatory Authority says so, and if we do not we will be in trouble” is
    likely to have amuch lower motivating force.
    Skills Training
    A wide range of skills is required. Some jobs are simple, routine, and repetitive.Others
    may require a considerable level of expertise, concentration, and judg -ment. It is neither
    possible nor appropriate to dwell here in detail on trainingin all possible specific skills.
    Suffice it to say that skills (e.g., operating amachine, servicing equipment) cannot be
    satisfactorily acquired in the class-room. This is preeminently a case for showing, for
    demonstrating, and forhands-on practice.In no other industry can the need for sound
    training be more obviously apparent, yet it is sadly true that, across the industry as a
    whole, there has been a wide spectrum of personnel policies and training approaches,
    from well-organized, efficient enthusiasm to lip -serving, indifferent inadequacy. (Fora
    further consideration of training and of training techniques see Annex 2 tothis chapter.)

    Assessment of Training
    The effectiveness of training should be assessed during each session by oralquestions and answers, and
    at the end of each by a simple, largely multiple-choice, question paper. In the longer term, assessment
    should be by observationof operator performance and adherence to systems and procedures, as
    notedduring periodic company self audits etc.
    Retraining
    Retraining and/or refresher training should be given whenever:(a)Assessment of post-training
    effectiveness, or(b)Changes in Company organization, systems or technologies indicate the
    need.

    Training Records
    There should be two types of training records:1 . T h e p e r s o n a l fi l e o f e a c h m e m b e r o f s t a f f
    s h o u l d c o n t a i n a r e c o r d o f the training received, indicated by module reference number (see
    Figure2.1).2.Departmental training records should be maintained, indicating in tabularform
    the training received by each member of staff (see Figure 2.2).

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