Our Services
OC Consulting offers a personalised consulting service on all areas of Good Manufacturing Practise (GMP) and Good Distribution Practise (GDP) as well as Good Promotional and Good Marketing Practises (GPP) , Good Vigilance Practise (GVP) and IPHA Codes of Practise to your Pharmaceutical company. With a passion for identifying, documenting and streamlining processes we are available to work with you to meet your business Quality System needs whether a short-term or long-term contract is required . We offer a pragmatic,collaborative compliant approach taking into consideration commercial considerations.
GMP/GDP/GPP/GVP Consulting Services
We provide advice and assistance on many services within the Pharmaceutical Industry. Below are the areas that OC Consulting can help you with in the area of Good Manufacturing Practice (GMP) , Good Distribution Practice (GDP) , Good Promotional Practices (GPP) and Good Vigilance Practice (GVP):-
- Quality System Implementation or Improvement
- New product Introduction/Technical Transfers
- Wholesale License Applications
- Change Management
- Vendor / Contract Organisation Management
- Supplychain Mapping
- Deviation Management
- Database Development
Responsible Person
Our highly trained contract RP can be deployed at short notice to assist with
- Wholesale Distribution Authorisation (WDA) license application
- Support you in Understanding the GDP and local Regulations
- Train your employees
Contract Quality / Compliance Services
We can tailor our quality compliance service to meet your business needs. So whether it is a short-term project or an additional quality resource that your business needs OC Consulting can offer assistance. Some areas we can help you with are
- Product Quality Reviews
- Risk Management
- Data Integrity Projects
- Technical Agreements
- Validation or Technical Transfer Documentation
- Marketing Authorisation Compliance Projects
- Trouble shooting & remediation of quality issues
Qualified Person
If you require a certificate of release in compliance with EU Regulations for Manufacture and Release of Finished Product, then our Qualified Person is available to fulfil a contract Qualified Person role for your company.
Auditing
OC Consulting having a qualified auditor can assist your business with your self inspection programme or assist with audit preparation for a notified body audit. Our services include
- Opening Presentation Preparation
- Audit Readiness Training and Preparation
- Self Inspection audit templates
- Self Inspection Audit Completion
- Vendor Auditing
- Corrective and Preventative Action Implementation
QPPV Services
If you require an EU Qualified Person for vigilance as per Dir 2001/83/EC as amended OC Consulting can assist your business. Our services include
- Provision of EU QPPV services as required by EU legislation and GVP EU Guidelines
- GVP Module and Vigilance Directive ( 2001/83/EC ) interpretation
- Good Vigilance Practise SOP compilation
- Quality Management System implementation
- Safety Data Exchange Agreements compilation
- Literature searching and review
