|
Quality & GMP Services
for the
Pharmaceutical and Biotechnology Industries
What can MEC do for your company?
Our Quality Advisors can assist you with the following:
Quality Management Systems for GMP
- Active Pharmaceutical
- Drug Products
- Contractors/Clients
Good Manufacturing Practice (GMP)
- Compliance
- Training
- Upgrade of GMP to meet CT Directive
- For MCA/FDA
Qualified Person Service
- Commercial Products
- Clinical Trial Supplies
- Complaints and Recalls
Quality Audits to GMP, GCP and GLP Standards
- Pre-Regulatory Audits
- Contractors
- Suppliers
- Laboratories
- Internal Audits
- Dossier Audits
- GMP, GDP, GLP, GCP
Quality GMP, GCP and GLP Documentation
- Technical Agreements
- Site Master Files
- Quality Manuals & Policies
- Validation Master Plans
- Validation Protocols & Reports
- SOPs, Specifications
- Batch Documents
- Stability Protocols and Reports
Management of Change for GMP
- Change Control
- Technology Transfer
Quality Systems for GMP and GCP
- Training
- Self-Inspection Programmes
Good Quality Control Lab Practice
- Analytical
- Micro Biology
- Product Testing
Looking for Additional Information?
Why not call us for an informal chat?
Marilyn Emery Consulting
33 Enterprise House
Springkerse Business Park
STIRLING
FK7 7UF
Scotland
|
|
Tel:
Fax:
Email:
|
+44 (0) 1786 445 777
+44 (0) 1786 849 269
info@marilynemery.com |
Those acronyms decoded:
| GCP | Good Clinical Practice |
| GDP | Good Distribution Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| IMP | Investigational Medicinal Products |
| QA | Quality Assurance |
| QP | Qualified Person |
| UK | United Kingdom |
|
