Tianjin Pharmacn audit report | Eurofins

The following Eurofins audit reports are available for Tianjin Pharmacn Medical Technology Co., ltd:

Tianjin Pharmacn Medical Technology, Tianjin - China, Audited on site (COMING SOON)


Eurofins Healthcare Assurance
 

Eurofins Healthcare Assurance helps pharmaceutical/healthcare manufacturers to control their complex supply chains with Quality Assurance and GXP Auditing services. The Audit process is fully customized to meet the client’s needs.
 

The scope of our Auditing services covers:
 

  • GMP (Good Manufacturing Practice) & ISO: Finished Products, APIs and Excipients, Starting Materials, Cosmetic Ingredients and Products, MD Components, Food (Dietary) Supplements, Packaging Materials, Service Providers for Analytical Testing, Sterilization, Maintenance, Validation, Storage, Distribution.
     

  • GLP (Good Laboratory Practice): Laboratories used to perform all non-clinical safety studies which are intended to support research permits or marketing authorization.
     

  • GCP (Good Clinical Practice): Clinical Research Organization, Investigation Center and Data Center.
     

  • GVP (Good Pharmacovigilance Practices): SDEA, Pharmacovigilance systems and services.


Audit Reports
 

By purchasing our Audit reports, pharmaceutical companies can qualify their suppliers saving time and resources.
 

Our Audit report documentation is supported by a CAPA plan, when applicable. We can also provide additional documents and services when required.
 

Our Auditors are highly qualified and spread all over the world, and their CVs will be provided as well along with each Audit report.
 

Our Audit reports are well recognized by international authorities (ANVISA, COFEPRIS, EMA, FDA, HC, TGA, MHPRA, Swissmedic, etc.) and ready to be used for QP declarations.
 

Our GMP Pharma Audit report covers the main quality topics: Introduction, Follow-up of the previous Audit, Quality management, Organization and personnel, Documentation and records, Complaints – Recall, Deviations - Corrective Action & Preventive Action (CAPA), Product Quality Review (PQR), Audits, Rejection and Re-Use of Materials, Validation, Change Control, Suppliers and contract manufacturers (including laboratories), Quality Risk Management, Facility tour, Storage and Warehouse, Production and packaging areas, QC laboratories, Distribution, Conclusion.

 

What is a Tianjin Pharmacn Medical Technology Co., ltd audit report?

Here you can find the GMP Audit Report for Tianjin Pharmacn Medical Technology Co., ltd.

This audit report is accessible to other pharmaceutical companies, providing a detailed evaluation of Tianjin Pharmacn Medical Technology Co., ltd's compliance with industry standards and regulations. What makes this report stand out? It's a deep dive into the company's operations, spotlighting their stringent adherence to industry norms, evidenced by certifications like GMP, CEP, DMF.

An audit report in the pharmaceutical realm is more than a mere document; it's a mirror reflecting a company's commitment to regulatory compliance, quality control, and internal policies. This report isn't just a checklist – it's a narrative showcasing how Tianjin Pharmacn Medical Technology Co., ltd aligns with the highest standards of Good Manufacturing Practices (GMP) and beyond. It doesn't just highlight compliance; it uncovers potential areas for enhancement, offering pathways for continuous improvement.


When do you need an audit report?

Utilizing this report means it's no longer necessary to audit this supplier yourself. The availability of this report demonstrates Tianjin Pharmacn Medical Technology Co., ltd's commitment to transparency and adherence to quality standards. It serves as a valuable tool for businesses looking to partner with or procure services from Tianjin Pharmacn Medical Technology Co., ltd, ensuring a well-informed and secure decision-making process. For further details and to access the full Tianjin Pharmacn Medical Technology Co., ltd GMP Audit Report contact us.

Pharmaoffer is dedicated to enhancing transparency and trust within the pharmaceutical industry, and this report is a key component of that mission. Would you like to learn more about it, click here and someone from the Eurofins team will reach out to you.

How much does an audit report cost?

The cost of a Good Manufacturing Practice (GMP) audit report can vary significantly based on several factors. Here's a general overview: 

  • Complexity of the Facility: The more complex the manufacturing processes and facilities, the more in-depth the audit will be, leading to higher costs.

  • Industry and Product Type: Certain industries, like pharmaceuticals, biotechnology, and food, have stringent GMP requirements, which can make audits more expensive due to the specialized knowledge and thoroughness required.

  • Location of the Facility: Geographical location can impact costs due to travel expenses for the auditors, local economic conditions, and regulatory variations.

  • Audit Duration: The length of time needed to complete the audit also plays a role. A larger facility or one with more complex processes may require more time to audit thoroughly.

  • Scope of the Audit: The specific requirements of the GMP audit (like whether it's for the entire organization or specific processes) can affect the price.

For a precise and detailed quotation that is specifically tailored to the Tianjin Pharmacn Medical Technology Co., ltd’s facility and operational scope, we encourage you to contact Eurofins directly.

Eurofins APIs on Pharmaoffer

Offers audits for industries as pharmaceutical, medical devices, cosmetic/personal care or food supplements.

GMP, GCP & GLP Audits

Additionally also internal audits programmes, Due Diligence Audits, GDPR audits

Our services:

GMP Audit Services
Third party audits
GxP Consultancy
Quality Assurance
Regulatory Compliance

Response time:

Tianjin Pharmacn

Tianjin Pharmacn Medical Technology Co., Ltd is a high-tech enterprise, integrating the R&D, manufacturing and marketing of active pharmaceutical ingredients (APIs) and intermediates. It has R&D center,  optimization and industrial preparation  pilot workshops. Dedicated to offering more advanced products to the world, the company established R&D center, quality inspection center and pilot test conversion workshop, currently Tianjin Pharmacn has three manufacturing sites in Tianjin,respectively located in Tianjin Dagang Chemical Industry Park, Tianjin Economic-Technological Development Area and Jinghai Pharmaceutical Industrial Park.  

Tianjin Pharmacn is one of integrated pharmaceutical companies in China focusing on the development and manufacturing advanced pharmaceutical ingredients , especially with domestic leading technology and manufacturing advantages in the field of anti-tumor, anti-infection and hypoglycemic drug intermediates . At the same time, the company can also provide impurity tracking, stability analysis and CTD documentation and other technical services.  Tianjin Pharmacn is equipped with more than 100 sets of 100L-5000L reactor, the annual manufacturing capacity is 500 tons. It can realize high and low temperature reaction at -100-240℃, various catalytic reactions and anhydrous and anaerobic reactions at 0~5MPa, and has the leading technical capability in the synthesis of heterocyclic compounds. 

Tianjin Pharmacn owns an experienced quality management team which has established perfect quality standard system and carried out whole-process supervision and management from risk assessment, product research and development, the enterprise transfer amplifier, manufacturing, sales and service process, to meet the customer quality requirements and provide a reliable guarantee.

Tianjin Pharmacn Medical Technology Co., Ltd will always be committing to provide high quality  product and services for pharmaceutical enterprises in domestic and oversea .