The PharSafer White Gloves Audit Group
Those of you from a military background or the quality checking for cleaning in very formal palaces will know that the way to know everything was as clean as possible was to put on the white gloves and run your fingers over every surface looking for dust where someone forgot to clean.
This activity has become synonymous with Quality and checking everywhere to ensure the highest possible standard.
Therefore, we considered it appropriate to call our audit team the White Gloves audit group – looking for Quality in all of our audit activities.
The PharSafer Audit Team
Our audit team has vast experience. We have attended over 100 inspections globally including FDA; HPB; EMA (and numerous National Agencies); and the MHLW.
We have conducted over 500 audits globally.
We have performed GCP; GPV audits as well as 21 CFR Part 11/GAMP 5 audits on systems validation.
Our team has over 60 years of audit experience.
We audit against multi-national legislation requirements.
We run interactive audit training courses on audit conduct and findings assessments and CAPA Management.
The Audit Types
The PharSafer team have audited many types of Companies from:
- Multi-National Generic Companies
- Top Ten Pharma Companies
- Biotech Companies
- Vaccine Companies
- Device Companies
- Other CROs
- Distributor partners
- Company and Product assessments as part of Due Diligence
- PSP Service Providers
- Safety Database Providers
The Audit Format
All audits include an audit template which follows deviations from the legislation and which piece of legislation was deficient and the extent of the deficiency.
Additional to the audit report, there is the issuance of the audit certificate and approval of any CAPA activities associated with the identified deficiencies.