Audits

THERAXEL carries out regulatory audits for you in order to prepare your next inspections by Health Authorities or customer audits and can also intervene following any discrepancies which affect the whole Quality Process.

We rely on the skills of our team of experts, experienced auditors in their respective areas of business in order to perform these audits.

Services

Management of Cross Contamination
Management of particulate, microbial and pyrogenic contamination
Quality system
Laboratory animal houses
Quality Control Laboratories

Customised

Management of contamination in non-sterile, sterile or cosmetic pharmaceutical industries
Management of viral and microbial contamination in laboratory animal houses

Standard

Sterile Pharmaceutical Industries

ANSM/ANSES – EMA Eudralex Volum IV Good Manufacturing Practices, Part I pour les zones de fabrication et les laboratoires de contrôle
ANSM/ANSES – EMA Eudralex Volum IV Good Manufacturing Practices, Annexe 1
ANSM/ANSES -EMA Eudralex Volum IV Good Manufacturing Practices, Annexe 15
FDA 21CFR Parts 210-211 Guidance for Industry « Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice »

Non-sterile Pharmaceutical Industries

ANSM/ANSES – EMA Eudralex Volum IV Good Manufacturing Practices, Part I for manufacturing areas and control laboratories

ANSM/ANSES -EMA Eudralex Volum IV Good Manufacturing Practices, Annexe 15

Cosmetic Industries

ISO 22716 : 2007 – Cosmetics Industry – Good Manufacturing practices (GMP)– Guidelines for Good Manufacturing Practices

Laboratory Animal facilities

Managing viral and microbial contamination in laboratory animal houses

THERAXEL undertakes to provide a full audit report with detailed proposals for improvement actions within one month.