Qualified Person Career Profile

Qualified Person (QP)

• Before certifying a batch prior to release the Qualified Person doing so should always ensure that the following requirements have been met:
• Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released for sale or supply in the EC/EEA or for export.
• The principles and guidelines of GMP as stated in Directive 2003/94/EC for medicinal products and IMP for human use, as interpreted in the EC Guide to GMP have been followed. Ensure all requirements under references have been met prior to release of a batch.
• The principal manufacturing and testing processes have been validated.
• All the necessary Quality Control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records.
• All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
• All necessary manufacturing, packaging and quality control documentation has been completed and endorsed by suitably authorised staff.
• To ensure that the legal requirements regarding imported products have been fully met.
• The general conditions as laid down on the Manufacturer's License orManufacturing Authorisation (IMB) are followed.
• The QP should maintain their knowledge and experience up-to-date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.
• The QP must carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study.
• The QP must maintain a register of all released batches.
• The QP must promote GMP through training and guidance internally.