Quality Management System of the manufacturer
In order to ensure that the quality objectives as well as regulatory requirements are met, at Zahravi Pharmaceutical Co., the senior management and all personnel are committed to ensure compliance by implementing a quality system that incorporate GMP and Quality Control.
Zahravi complies to Iranian GMP and WHO GMP standards. It is the intent of the management of Zahravi to achieve compliance to PIC/S GMP standards according to its GMP Compliance Plan.
This is achieved by implementation of a Quality Management System that documents and records all the procedures and activities in the factory and maintained by the following systems
- Quality risk assessment
- Deviation management
- Change Control
- Corrective Actions and Preventive Actions (CAPA)
- Document system management
- Internal Audits
- Supplier evaluation and audit
- Validation and qualification
- Stability program
- Quality Control activities
The Quality Assurance department is responsible for
- Implementing the GMP requirements
- Ensuring that job responsibilities and all production operations are clearly defined.
- Ensuring that all laboratory and production instruments and machines are qualified and production process and analytical methods are validated.
- The authorization of written procedures and other documents, including
- The monitoring and control of the manufacturing environment;
- The designation and monitoring of storage conditions for materials and products;
- The retention of records;
- The inspection, investigation, and taking of samples, in order to monitor factors
which may affect product quality;
- Participation in management reviews of process performance, product quality and
- of the quality management system and advocating continual improvement
Elements of the Quality Assurance (QA) system:
- Overall GMP compliance of the plant to ensure safety, efficacy and purity of products manufactured.
- There is Standard Operating Procedure formally established for activities related to manufacturing quality products.
- All starting materials and packaging materials are evaluated and approved to defined specification prior to production use.
- All appropriate control on intermediate products and any other in-process control arrangement are carried out.
- Finished products are correctly manufactured and checked according to the defined procedures.
- Products are released for sale when the products are manufactured in accordance to the procedure and all tests meet the specifications.
- The quality of the product is ensured throughout the designated shelf life during distribution and storage, through stability study program.
- Self inspection program is in place which regularly appraises its effectiveness.
- Product Quality Complaint procedure is established for thorough investigation into the root cause and implementation of appropriate corrective action and preventive action.
- Good Documentation is practiced to ensure traceability and easy retrieval.
- Validation Master Plan is available to detail the company's policy and plan on validation.