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Routine Duties Of A Qualified Person
By Generic Drugs Frequently Asked Questions
A Qualified Person is required to perform routine duties in line with the general principals of a QP. A Qualified Person must ensure that the following criteria is completed before batch release is possible: The batch must meet 'The Marketing and Manufacturing Authorisation or Investigational Medicinal Products Authorisation' requirements for Medical Products.
The GMP guidelines as stated in Directive 2003/94/EC (human) or Directive 91/412/EEC (veterinary).
Validation of the principal manufacturing and testing processes.
Performed the necessary quality control checks and tests in line with manufacturing procedure.
Review of batch records.
Any deviations in packaging, quality procedure or manufacture to be notified in accordance with the defined reporting system before any product is released.
Additional sampling and inspection, tests and checks to be carried out in response to any deviations.
Regular audits, spot checks and self-inspections.
All legal requirements are met.
Maintain a register as a record of product batches that have been released by the Qualified Person.
Retain reference samples of each product at the site of manufacture
for the required amount of time as specified by the EU regulations.
To ensure that any tasks that the QP has allocated to existing staff are being performed to the required GPM and EU standards.
The overall task of a Qualified Person is to produce an overall plan for the quality management system. It is the duty of the Qualified Person to make sure that any tasks that have been allocated are being performed to the necessary standards. Hence the routine duties of the Qualified Person depends very much on a team effort where in the individuals realise the responsibility of the Qualified Person and offer the support required. Matt Tong has built up relationships within the pharmaceutical industry in order to offer consultant QP services with expertise across the full spectrum of human and animal drugs/medicines. The consultants provide services in the areas of batch realise, facility audits, industry standards, QA/QC advice and regulatory assistance in the UK and Europe. For more information please visit: Qualified Person Service
Or email mtong@generic-software.com
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