Audits

You need to know if your facilities and procedures are compliant with Regulatory Authority requirements.

You need also to audit your production and distribution chain, including:

• Sub contracting manufacturers
• Suppliers of APIs (Active Pharmaceutical Ingredients)
• Suppliers of packaging materials
• Services providers

Therefore, Galenisys can help you in conducting:

Compliance audits of your facilities and procedures

If you want to make certain your facilities and procedures are compliant with regulations, ask Galenisys to perform a compliance audit.

We have experience of audits in the Emerging markets. We can conduct complete compliance audits for GMPs and also GLPs and GCPs.

If you need to make sure your quality system complies with the regulations set out by a specific agency, Galenisys can provide a complete audit of your quality systems, helping you to identify and make changes wherever needed.

When the audit is complete, we will provide you with a formal report as well as follow-up consultations to monitor and implement corrective actions.

If your company strategy is to develop its business in exporting to new markets in Europe or the USA for reaching new and profitable markets, Galenisys consultants are up to date with the latest FDA and EMA regulatory requirements and have extensive experience working with major manufacturers and regulatory authorities. They can offer expert advice on GMP,GLP and GCP with the specific requirements of:

• The US FDA
• The French ANSM
• The European EMA

If your facility is about to be inspected, then Galenisys can help you to be fully prepared with a pre-inspection audit. Galenisys can perform a Quality and Compliance risk assessment followed by an action plan and supported by any necessary training.

Manufacturer audits

If your company is subcontracting the manufacture of your product(s) your company needs to know:

• Is the process validated properly ?
• With validated equipment?
• Is the supplier’s quality system compliant with the regulatory requirements ?
• Is the technical agreement between your company and the supplier covering all aspects ?
• Does the technical agreement between your company and the supplier cover all of the required points ?

Galenisys can train your staff to ensure that they have the necessary skills and experience to examine all of these requirements or we can audit the supplier on your behalf.
Do not hesitate to contact us.

Supplier audits

All raw material suppliers must be audited. It is a GMP obligation. Galenisys has the experience of auditing such companies in India and China and of course in Europe. They have extensive experience interacting with regulatory authorities in North America, Europe, Australia, Japan and Latin America.
Do not hesitate to contact Galenisys to audit your suppliers throughout the world.

We can also broaden the scope of our audit to include all areas of your company’s or facility’s activities, including:

• Due diligence
• Product and process development
• Capital investment projects (please refer to the relevant page)