• Compliance of batch manufacturing as per market authorization requirements.
• Product has been manufactured according to the GMP standards.
• The principal manufacturing and testing processes of the products have been validated.
• Account has been taken about the actual production conditions and manufacturing records.
• Any deviations or planned changes in the production and quality control of the products have been
authorized by the persons responsible as per the defined system.
• Any changes requiring variation to the marketing or manufacturing authorization have been
notified and authorized by the relevant authority.
• All the necessary tests have been performed on the products, including additional sampling, and
inspection initiated because of deviations or planned changes.
• All necessary production and quality control documentation has been completed and endorsed by
the authorized staff.
• All audits are carried out as required by the quality assurance system.
- A qualified person shall be in possession of a diploma in pharmacy.
- At least 5 years of related experience.
- Expert in GMP requirements.
- Expert in pharmaceutical law, quality management systems and the professional duties of a QP.
- Medicinal chemistry and technical pharmaceutical knowledge.
- Ability to cope well under pressure, make confident judgements and act decisively when things go