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Would like to get views on management actions / approach for planning, execution and sustaining GMP Practices at workplace in manufacturing operations.
throught force of management to lead all group to implmentation to increase of level to tools to GMP and comply with all needs to tools GMP and GHP
should have a very clear understanding of responsibilities of all stake holders / team members. It should also be ensured that every individual responsible is fully aware of his responsibilities and should also possess requisite potential to perform/deliver to the required standards.
All necessary facilities for GMP are provided, including
A) Products are designed and developed in a way that takes account of the requirements of GMP.
B) Production and control operations are clearly specified in a written form and GMP requirements are adopted.
C) Managerial responsibilities are clearly specified in job descriptions.
D) Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
This is the all way of good cGMP practies.
Management Responsibilities Delegate the Power to the down the line Person and Contineous Monitoring in the implementation of cGMP Practises at all level of Activites and Assign the Responsibilites towards the concern
cGMP practices need to be mapped with management strategic plan/objective to evaluate integration success.
Mapping include objectives/roles/process control to ensure KPIs are met.
To accelerate the implementation of cGMP practices-