Pharmaceutical Quality and GMP audits

We perform comprehensive third-party inspections for the production company.

Our audits are systematic and independent investigations in which you find out whether the operations performed by your company comply with the standard regulations.

You will also get practical information and information about whether they are effectively implemented to achieve the required goals.

 We help companies improve their business and achieve profitable growth with better customer satisfaction.

In the pharmaceutical business, we have been conducting external audits for decades.

Here are our latest references:

Training modules

We offer training and coaching in the form of daytime, evening and online coaching. We also organize the trainings at companies' own premises. Developing skills is an investment!

BUILD A QUALITY SYSTEM

•How to build up a Quality system (e.g.according to ISO9001, Eudralex Vol 4)

•What are the first elements needed

•What are the advantages

•How to maintain the Quality system up to date

•How to develop

EFFECTIVE DEVIATION IN­VES­TI­GA­TION

•Why the deviation investigations are important

•What are the key steps

•How to classify

•Who should involve

•How to investigate

•How to report easily

BE PREPARED TO AUDITS AND INS­PEC­TIONS

•Basic principles

•How to behave

•How to respond

•Know the structure and follow up

GENERAL GMP TRAINING

•History

•Regulations

•Principles

HOW TO PERFORM AN AUDIT

•Audit preparation

•Audit execution

•Audit reporting

Quality is Eve­ryt­hing but without Con­ti­nuo­us Im­pro­ve­ment there is no Quality.

A con­ti­nuo­us im­pro­ve­ment process (abbre­via­ted as CIP or CI), is an ongoing effort to improve products, services or processes.  Con­ti­nuo­us im­pro­ve­ment is also known as rapid im­pro­ve­ment. These efforts can seek "incremental" im­pro­ve­ment over time or "breakth­rough" im­pro­ve­ment all at once.

By using Six Sigma and Lean im­pro­ve­ment tech­niques, it can be help to stream­li­ne workflows. 6Sigma stra­te­gies are seek to improve manufacturing quality by iden­ti­fying and removing the causes of defects and mi­ni­mizing variability in ma­nu­fac­tu­ring and business processes.  

This is done by using empirical and sta­tis­tical quality management methods. Each 6Sigma project follows a defined met­ho­do­lo­gy and has specific value targets, such as reducing pollution or inc­rea­sing customer satisfaction.

The Lean way of working enables efficient workflows that save time and money, allowing you to reduce wasted time and effort.