Pharmacosmos audit report | Rephine

The following Rephine audit reports are available for Pharmacosmos:

Pharmacosmos


To get more information on audit reports by Rephine, please click the green button below to get contacted by Rephine!

 

What is a Pharmacosmos audit report?

Here you can find the GMP Audit Report for Pharmacosmos.

This audit report is accessible to other pharmaceutical companies, providing a detailed evaluation of Pharmacosmos'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 Pharmacosmos 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 Pharmacosmos'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 Pharmacosmos, ensuring a well-informed and secure decision-making process. For further details and to access the full Pharmacosmos 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 Rephine 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 Pharmacosmos’s facility and operational scope, we encourage you to contact Rephine directly.

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Providing specialists quality assurance services for more than 25 years.

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Our services:

GMP Audit Services
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Pharmacosmos


Pharmacosmos is a global leader in carbohydrate manufacturing and dextran fractionation, offering high-quality dextrans and dextran derivatives as APIs or excipients. We also provide customer-specific dextrans and comprehensive Contract Development and Manufacturing Organisation (CDMO) services.

All our products are manufactured in a state-of-the-art cGMP facility in Denmark, inspected by both FDA and EMA. Our unique production process exclusively uses water-based chemistry, completely avoiding the use of organic solvents.

Pharmacosmos sells and ships directly to clients worldwide, ensuring reliable and efficient delivery.

 

Dextran Products:

Pharmacosmos provides pharmaceutical-quality dextrans of the highest standards, including those of the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and the Japanese Pharmacopoeia (JP). These dextrans are available as active pharmaceutical ingredients (APIs) or excipients, ensuring high chemical and biological purity. The company also offers custom dextran derivatives, including Amino-Dextran (AmDex), Carboxymethyl Dextran (CM-Dextran), and DEAE-Dextran, tailored to specific customer requirements.