GMP Compliance Audits

GMP Compliance Consulting
We have an international client base covering Gulf countries, South East Asia and India. We are flexible and responsive to meet your specific needs.
Our GMP compliance consultancy services include:

• Setting up GMP- compliant Quality Assurance systems
• Supplier audits
  
• Interim management
  
• Staff training
  

We have particular experience in handling active pharmaceutical ingredient (API) audits.

GMP- Compliant Quality Assurance Systems

GMP technical solutions help companies to set up GMP-compliant quality assurance systems that are appropriate to their needs.  We provide a range of services to ensure that you and your contractors meet EU and FDA Good Manufacturing Practice requirements, including:

• Preparation of Standard Operating Procedures
• Preparation of Validation Master Plans
• Preparation of Site Master Files
• Staff training
• CAPA
• Technical/Quality Agreements
  

Our expertise covers Active Pharmaceutical Ingredients, Investigational Medicinal Products, sterile and non-sterile dosage forms and biotechnology products.

Complaince Audits

We can audit any type of activity against all the major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more.

Complaince Audits.

• Audits of companies wishing to import products into different countries
• Pre-audits in preparation for competent authority (eg EMEA, MHRA, FDA) inspections
• Design and management of corrective action plans
• Oral solid dosage manufactures
• Liquid manufactures
• Topical manufactures. (WHD & LOCAL SCHEDULE M GUIDELINES)
• Audits for medical devices manufactures as per ISO 13485
• ETO sterilization unit
• Gamma Irradiation unit