GMP Audits Germany

PHARMALANE UK provides a third-party GMP auditing service in Germany and across the world, with high-level GMP audits of various supplier types conducted by various regulatory requirements (such as EU GMP, ICH Q7, 21 CFR 210/211, ISO, etc. for GMP). Their quality auditing service comprises all the necessary procedures, such as audit planning, travel, auditing, reporting, audit closure, and more, and it begins with initiating the audit with the supplier. In short, pharma lane is one of the best GMP audit companies in Germany.

In addition to performing thorough inspections and promoting open communication between auditors and supplier chains, Pharmalane thinks that its timely report delivery is one of its biggest capabilities.

By prioritising report drafting as a time-sensitive requirement, the quality and quantity of essential details can be recorded more effectively, hence, optimising the quality of remedial recommendations.

Pharmalane’s auditors possess the greatest level of technical expertise due to their specialised training by audit type and scheme, which mandates in-depth training and stringent internal audits.

QIMA and the FDA share the objectives of information openness and auditing refinement. They share a dedication to food safety and public health above everything else. Let the GMP audits verify that the best procedures for food handling are applied at the source.

Make sure your team has reviewed every document that an auditor is likely to require before the audit. Ensure that all paperwork is readily available and that all distributed documents are “controlled copies” and current.

• Relevant documents and records pertaining to the management system
• Applicable criteria
• Site master file 
• Records of Training 
• Standard operating procedures

Typically, the auditor will examine the following documents prior to visiting your location:

• Site Master File (if the auditor is unfamiliar with your site) 
• Validation Master Plan (prior audit results and your responses to complaints and adverse occurrences) (if the auditor is unfamiliar with the site)