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Release procedure of finished products

the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP). If the product review found satisfactory, the Responsible Pharmacist or designee shall release the product for sale and distribution.

After release, finished products should be stored as usable stock under conditions established by the Zahravi Pharmaceutical Co.

Also a qualified Person (Responsible Pharmacist) must reviewing the Master Documents such as SMF, VMP, protocol, Quality Manual and etc, And ensure that:

  • All activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles and guidelines of GMP.
  • All manufacturing activities and testing activities are consistent with those described in the MA.
  • All records are complete and endorsed by appropriate personnel. All required in-process controls and checks have been made.
  • The self-inspection program is active and current.
  • All investigations pertaining to the batch being certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support certification.
  • Any on-going complaints, investigations or recalls do not negate the conditions for certification of the batch in question.

  • Provided registered specifications for active substances, excipients, packaging materials and medicinal products are met, a QP may consider confirming compliance or certifying a batch where an unexpected deviation concerning the manufacturing process and/or the analytical control methods from details contained within the MA and/or GMP has occurred. The deviation should be thoroughly investigated and the root cause corrected. This may require the submission of a variation to the MA for the continued manufacture of the product.