GMP Compliance Adviser

GMP Compliance Adviser is a simple and flexible online tool that provides the most up-to-date GMP information to facilitate compliance with international regulations.

What are the advantages of the GMP Compliance Adviser?

I. Quality at all levels in the processes of pharmaceutical plants

• Prepares procedures and facilities for inspections at any time.
• Provides all international regulations.
• Authorized procedure templates are available for rapid development of standard operating procedures (SOPs).
• Covers all aspects of quality, regulatory and compliance standards in manufacturing, packaging, facilities, documentation, IT, audits and more.

II. Procedures and facilities ready for inspection at all times

• You have a comprehensive and detailed guide to regulatory compliance, as well as specialist knowledge and advice on how to prepare for (and pass) inspections and audits.
• Provides resources for all team members at every level of quality and compliance.
• Faithfully following the GMP Compliance Adviser recommendations will virtually guarantee the approval of inspectors and auditors.

III. Solving problems and challenges at the level of quality, regulation and compliance

GMP Compliance Adviser is the online solution of reference at the time of:

• Solve problems of corrective and preventive actions
• Use quality, compliance and regulatory checklists for your people
• Consult the regulations
• Create a standard operating procedure (SOP)
• Establish guidelines for adequate documentation
• Prepare for future inspections and audits
• Correct deficiencies resulting from an inspection or audit
• Update teams on quality and compliance procedures

IV. Bibliography of the entire GMP context

GMP Compliance Adviser provides a single source for EU, FDA, WHO, PIC/S, ICH and HC requirements. It also provides access to a comprehensive guide to the following; all available for your search so you get instant answers:

GMP Regulations

1. Address
2. National bodies and pharmaceutical associations
3. EU Directives and Guidelines
4. U.S., CFR, and FDA Guidelines
5. ICH Guidelines
6. PIC/S Guidelines
7. GMP from other regions
8. WHO guidelines

GMP in practice

1. Pharmaceutical Quality System (PQS)
2. Staff
3. InstallationsServices and equipment
4. Water for pharmaceutical use
5. Training
6. Validation process
7. Other services