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Q 2. Describe in brief the basic principles followed by the GMP principles


Answer:
Success of a Project greatly depends on adopting. Good Manufacturing Practices (GMP) and help the project meet the overall project quality, timeline, and cost objectives. GMP tries to bring a manufacturing organisation to a level where it can compete effectively in the world market.
The World Health Organization (WHO) initiated the concept of GMP in the 1960s for high risk sectors like health, pharmaceuticals, food industry.
GMP is that part of Quality Assurance which ensures
that products are consistently produced and controlled to the quality standards appropriate to their intended use and as per specified requirements. GMP is nothing but adoption of such methods that try to ensure that quality is built into the organisation and the processes which are involved in manufacturing. The activities involved in achieving quality cover much more that the manufacturing operations themselves. GMPs are like policy programme implemented by manufacturers. They need a written programme, training programme, a maintenance schedule, and above all management commitment in providing funds, guidance, and human resources. Only when the management is committed to implement a programme, other components fall in place. Without this no amount of investment or external assistance can deliver results.
Good Manufacturing Practices are enforced in
• United States by the FDA (Food and Drug Administration)
• United Kingdom by the Medicines and Healthcare Products Regulatory
Agency (MHRA)
• Australia by the Therapeutical Goods Administration (TGA)
• India by the Ministry of Health, multinational and/or foreign enterprises
For a GMP, there must be clear written specifications for the materials, the packaging, processing and testing, handling, storage, receipt and dispatch.
Suitable infrastructure, location, equipment and trained employees must be made available to effectively implement a GMP program. It also requires regular audit and review of the GMP along with analysis of customer complaints and feedback. GMP must also be applied to sub contractors. In addition to these key aspects being addressed by any GMP program in an organisation, there are some practical aspects of GMP which need to be considered while adopting them. Adoption of GMP requires elaborate documentation of all the procedures and guidelines. Even results of procedures must be documented and analysed regularly. Also, to be able to implement GMP, the employees must be rigorously trained in GMP. Only then it can be effective.
Though no two GMP compliance plans are the same, they are all based and operate on the same fundamental principles and laws. In addition to GMPs, other key regulatory requirements apply to stakeholders and they can affect the overall GMPs. For example, regulatory mishaps at any point in the outsourcing chain can compromise the business objectives of all involved. Therefore it must be ensured that each stakeholder properly adheres to the additional regulatory stipulations for the GMPs to be fully effective.


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