GMP Consulting
Consultants team supports you on all GMP inspection preparation steps:
- Analysis of the current GMP status of a site (Mock Inspection)
- Audit report and CAPA development
- CAPA support:
- GMP training
- SOP Writing and Review Services
- Audit of suppliers and contract manufacturers
- Qualification and validation
- CAPA implementation control
We offer three levels of support for GMP Projects:
- Enhanced Business Support
- Standard Business Support
- Online Business Support
Enhanced Business Support
Our staff is on site 40 hours a week, integrated in your teams. This way you benefit from an efficient support in all your GMP matters by professional personnel.
Possible Services:
- GMP training
- Business process re-engineering
- Qualification and validation
- Review of marketing authorisation documents
- Implementation of GMP requirements in the company
- Preparation of APQR & stability reports
- Batch Record Review
- Change request control
Standard Business Support
The first step of GMP inspection preparation is GMP pre-inspection. During of pre-inspection GMP complience will be checked and gaps will be identified. We offer the following servises to meet GMP complience:
- Audit report and CAPA development
- CAPA support:
- GMP training
- SOP writing and review services
- Audit of suppliers and contract manufacturers
- Qualification and validation
- CAPA implementation control
Online Business Support
Remote communication is fulfilled via e-mail, telephone or Skype.
Possible Services:
- Consultation on the request
- Online GMP training
- Qualification
- Validation
- SOP writing and review services
- Multivariate statistical process control implementation support
GMP Audit of API manufacturers
In accordance with GMP requirements suppliers of API’s (Active Pharmaceutical Ingredients) to be audited by their client. India and China is a source of 90% of all API’s, auditing in these countries might be complicated. Regulatory authorities do not consider ISO, GMP or other certificates to be sufficient proof of quality, as such you are required to perform an audit regularly.
Our consultancy is based on the following Standards:
- FDA
- EU/EMA
- WHO
- PIC/S
- Pharmacopoeias (EP/USP)