Inke S.A. audit report | Rephine

The following Rephine audit reports are available for Inke S.A.:

Inke S.A.


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

 

What is a Inke S.A. audit report?

Here you can find the GMP Audit Report for Inke S.A..

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

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Inke S.A.


Inke S.A., a wholly-owned subsidiary of Neuraxpharm, is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes, mainly for use in inhalation therapies and CNS. Based in Barcelona (Spain) and counting more than twenty years’ experience in micronization, Inke is in continuous international expansion since 1998, delivering APIs all over the world, including US, Europe and Japan. Inke has been successfully inspected by most major global authorities for a wide array of products. Inke develops, patents and implements new polymorphic forms and salts and its own synthesis routes for the manufacture of active substances. Given the specific requirements for these products, this strategic commitment has involved an increase in the level of technical and regulatory collaboration with our customers.