Qualified Person (QP)

1. Before certifying a batch prior to release the QP doing so should ensure, with reference to the guidance above, that at least the following requirements have been met:
a. The batch and its manufacture comply with the provisions of the marketing authorization (including the authorization required for the importation where relevant).
b. Manufacture has been carried out in accordance with Good Manufacturing Practice or, in the case of a batch imported from a third country, in accordance with good manufacturing practice standards at least equivalent to EU GMP.
c. The principal manufacturing and testing processes have been validated, account has been taken of the actual production conditions and manufacturing records.
d. Any deviations or planned changes in production or quality control have been authorized by the persons responsible in accordance with a defined system, as well as by the QP Any changes requiring variation to the marketing or manufacturing authorization have been notified to and authorized by the relevant authority.
e. All the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
f. All the necessary production and quality control documentation has been completed and endorsed by the staff authorized to do so.
g. All audits have been carried out as required by the quality assurance system.
h. The QP should in addition consider any other factors of which he is aware which are relevant to the quality of the
batch.
2. The QP should maintain his knowledge and experience up to date in technical and scientific progress and changes in quality management and applicable GMPs relevant to the products which he is required to certify.
Location: Kaveh Industrial City (Saveh)