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Quality Assurance
Quality Assurance
Quality Management
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[Position]:Medipro > Quality > Quality Assurance
Quality
1 Management is committed to good professional practice and the quality of its analytical services. All tests will be carried out in accordance with stated validated methods.
Excellence in the workplace is promoted by providing all employees with the knowledge, training and tools necessary to perform their daily work in an efficient way.
We are committed to maintaining and continually improving our management system. All our employees and our suppliers are invited and expected to share this commitment.
It is clearly important that we are all aware of our dedication to Quality & its absolute importance in the successful running of the business.
2 The Technical Division should have the necessary authority & resources needed to meet the mandates assigned to them. The management and personnel of the Technical Division are to be free from any undue internal and external, commercial, financial and other pressures that may adversely affect the quality and integrity of their work. The Technical Manager will report directly to the Chief Executive Officer.
3 Medipro Pharmaceuticals Co LTD has currently in its employment a Technical Manager, Quality Control Manager, Analysts, In-process inspectors Documentation Controller, Regulatory personnel and Product/Validation Chemist.
The individual job function (QA/QC) is as follows:
Technical Manager
Maintaining a master list of current versions of quality documentation and ensure that a copy of historical quality documentation is archived.
Maintaining the complaints register with the corrective action.
Handling the maintenance and distribution of the management system documentation.
Managing the external and internal inspection program.
Commitment to process of continuous improvement.
Operate at required safety level and meet all environmental regulations.
Q.C. Manager
Commitments to: improvement in methods & introduction of technologies to the laboratory.
Supervising the laboratory testing program.
Ensuring that the appropriate samples are being run during analyses. These include blanks, spike recoveries, replicates, certified reference materials and in-house reference materials.
Monitoring the statistical analysis of quality control data and ensuring that the stated acceptance criteria are adhered to.
Preparing and maintaining the calibration schedule.
Maintaining the corrective and preventative action plan.
Staff training.
Analysts
Maintaining a safe working environment.
To maintain the integrity of the analytical services and the accuracy and reliability of all testing.
To prepare raw material and finished product specifications.
In-Process quality control inspectors.
Maintaining a safe working environment
To perform in-process control testing against approved specifications.
To monitor, checks and approve all line clearances.
4 Audit programs. Plant auditing will occur at a frequency of once every 3 months following the audit check document.
Medipro Pharmaceuticals Co LTD will run external independent auditing with a short frequency timeframe in the initial operational stages. Auditors familiar with the PIC/S GMP and complementary medicines will be contracted to ensure the ongoing compliance to mandated standards.
5 All raw materials and finished products comply with the specifications. The manufactured formula complies with the listed product. Deviations, if any, to be assessed and evaluated for any impact on the product safety and efficacy.
6 Suppliers will be assessed based on our supplier audit criteria and what type of accreditation they are holding from their regulatory body. Medipro Pharmaceuticals Co LTD will operate a vendor assurance program.
7 Using the company audit check sheet for audit