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Phar­maceu­tical Quality and GMP audits

We do a comprehensive third-party inspections of a production company



Our audits are systematic and independent examinations wherein you will establish whether the activities that your company performs are compliant with standard regulations.  


You will also get a pragmatic knowledge and information about, whether are the effectively implemented to achieve the required objectives.




We are helping companies to improving their business and achieving pro­fi­table growth with better customer sa­tis­fac­tion.

In pharmaceutical business we have done external audits for decades. 



Here are our latest references:

 

Case Thailand A
- 2022
- EU GMP part II (ICH Q7)
- EU GDP API

Case Phillippines
- 2022
- ISO 9001:2015
- PIC/S
- Korea GMP

Case Thailand B
- 2022
- EU GMP part II (ICH Q7)
- EU GDP API



Training modules

We provide training and coaching as day, evening and online training. We also organize trainings at companies' own premises. Developing skills is an investment!


BUILD UP 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.