Recently, AUSTAR has been chosen for a quality management system improvement project for a large state-owned listed pharmaceutical company in China which has a focus on OTC drugs and active pharmaceutical ingredients (APIs). AUSTAR Compliance Consulting Services is providing PQS consulting services for the company, including comparative analysis of regulations and guidelines, training and guidance, and providing hands-on assistance, etc., and ensuring that our client achieves PIC/S GMP.
With the increasing regulatory requirements and evolving development of technologies in the worldwide pharmaceutical industry, effective management of pharmaceutical manufacturers is essential to ensure product quality and compliance with regulations. Equipped with mature and continuously improving knowledge system as well as well-established technical support teams and execution teams, AUSTAR Compliance Consulting Services has rich industry experience in providing professional and comprehensive compliance consulting services for pharmaceutical manufacturers.
•Keeping track of international regulations and guidelines for utilization
•Based on ICH Q10
•Risk and Science based approaches
•Encouraging Proactive Management rather than Passive Management
•Realizing reducing operation costs, increasing customer satisfaction, and achieving overall profitability through robust PQS
•Combining the reality of clients to achieve operational excellence
Focus on Pharmaceutical Industry
Antibody /CGT/ADC /Vaccine /Blood Product /Sterile Product /Oral Solid Product /API, etc.
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We have already succeeded in helping many clients in the pharmaceutical industry pass international GMP certification. For example:
•Following FDA cGMP, AUSTAR Compliance Consulting Services provided compliance consulting services, including GMP design review, QMS, equipment and facility validation and GEP system, for an integrated pharmaceutical group, which strongly supported one of its production lines for oral solid dosage, injection and inhalation preparation smoothly passed FDA pre-approval inspection (PAI).
•Following EU GMP, AUSTAR Compliance Consulting Services provided compliance consulting services in the areas of Computerized Systems Validation, Data Integrity for a highly potent APIs manufacturer, which strongly ensured that its products passed EDQM Site Inspection and CEP certification.