Coral Drugs audit report | Rephine

The following Rephine audit reports are available for Coral Drugs:

Coral Drugs


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

 

What is a Coral Drugs audit report?

Here you can find the GMP Audit Report for Coral Drugs.

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

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Coral Drugs


Headquartered in New Delhi, India, is an integrated, research-based international pharmaceutical company that produces a wide range of high-quality, affordable, active drug ingredients (APIs).

 

Coral has made significant progress as an independent API manufacturing company. We manufacture our APIs across multiple therapeutic segments, including antineoplastic, steroids, non-steroids, hormones and beta-agonists. Having clients all over the world, we assume a great level of corporate responsibility. Adhering to quality production standards across the globe, Coral Drugs takes pride in being a truly international supplier of high-quality pharmaceuticals.

 

At Coral, we believe in excellent quality standards for our products and services across domestic and overseas markets. Our commitment to quality is well demonstrated by our compliance to several local and worldwide regulatory governing authorities. Apart from staying compliant with governing agencies, we partner with our customers to produce the highest quality pharmaceuticals. Coral achieves this by making our facilities available for regular customer audits. Our love of science enables us to consistently better our products and systems, while our dedication to obtaining approvals across the world helps us partner with our clients effectively. The partial list below demonstrates our commitments: Approvals and Filings • United States Food and Drug Administration (US FDA) • European Union GMP (EU) • Haryana FDA – GMP • CDSCO – WHO GMP • Written Confirmation as per EU Directive 2001/83/EC • ISO 9001:2008 Quality Management Systems • Drug Master Files (DMFs) and submissions worldwide Commitment to Excellence • Independent Quality Labs and Management Systems • Independent R & D Labs • In-house Microbiological Lab • Validated process and systems • Complete compliance to state industry norms.