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Pharmaceutical audit Consultancy

PHARMALANE is a Pharmaceutical service provider offering numerous services, including GMP audit, regulatory services, and quality compliance. Now you might be wondering why these services are essential for your business. The following details and the importance of every service provided by PHARMALANE, a Pharmaceutical service provider in Germany, will help you to understand the importance of these services-

GMP Audits

A GMP audit verifies that the manufacturing of items was as per excellent quality standards, current best practices, and the rules and guidelines established by the applicable health authority. Manufacturers must do GMP audits of suppliers themselves or hire competent Third party audit reports in Germany having experience as authorities raising the importance of on-site audits and have called for heightened surveillance of the pharmaceutical supply chain. GMP audits also help a company provide management with insight into how well their processes and goods are monitoring for quality.

Regulatory Affair Services

The creation of department of Regulatory Affairs was for safeguarding public health by keeping an eye on and regulating the efficacy and safety of drugs across various industries, including pharmaceuticals, veterinary medicines, agrochemicals, cosmetics, etc. For example, a pharmaceutical company’s regulatory affairs (RA) division secures permission for new pharmaceutical goods. It ensures upholding of approval for as long as the company desires to sell the product.. Regulatory affairs’ primary responsibility is offering technical and strategic guidance to the company related to the pharmaceutical industry, from medicine development to effective product marketing.

Quality Compliance

Pharmaceutical quality compliance ensures that the drugs produced will have the desired effect on the patient. Additionally, quality compliance ensures that no contaminants are present and that the pharmaceuticals will adhere to all applicable laws and standards for quality. Quality compliance is necessary for the company for various benefits, including public safety, prevention of negative publicity, Guarantee Compliance, and more.

Third-party Audit Reports

Our service auditor report delivers assurance around the business environment to help organizations comply with essential rules and guidelines on outsourcing services. We are a leading third-party pharma GMP auditing company to deliver detailed auditing reports. 

Joining Reports Library

Join our audit report library to collaborate with us. Our extensive library holds a rich collection of electronic and printed resources to include comprehensive drug information systems.

Quality Audits

Get our comprehensive quality assurance expertise for pharmaceutical suppliers. We have extensive experience in auditing pharma organizations as per the available standards and regulations. 

How can Pharmalaneuk help you?

Pharmalane UK is the pharmaceutical service provider for a Pharmaceutical Company in Germany that can help you provide the Global GMP Audit Library, regulatory service, and quality compliance. Want to know how can Pharmalane UK can help you with these services.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.