SOP on function of quality assurance department
Objective: To describe the guideline for the function of quality assurance department.
Scope: This SOP applicable for the function of quality assurance department of the Formulation plant.
Responsibility: Quality assurance department.
Accountability: HEAD – QA shall accountable for compliance of SOP.
Procedure:
Ensures that:-
Medicinal products are designed and developed in a way that takes account of the requirements of GMP.
Production and control operation which are clearly specified and GMP adopted.
Key person’s responsibilities are clearly specified.
Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
All necessary controls on intermediate products, other in-process controls and all validations are carried out.
The finished product is correctly processed and checked, according to the defined Procedures.
Medicinal products are not sold or supplied before Q.A. has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal products.
Satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled, so that quality is maintained throughout their shelf life.
There is a procedure for self-inspection and / or quality audit which regularly appraises the effectiveness and applicability of the QA system.
GMP and On Job Trainings are carried out for all plant personnel.
Pest control activities are carried out effectively.
All necessary safety measures shall be taken.
All documentation issue & control.