Infill Life Science

Pharmaceutical / Biopharmaceutical-Quality-Regulatory Compliance

Infill team is experienced in evaluating GMP systems of pharmaceutical manufacturers (viz. APIs, excipients, finished dosage form, analytical testing laboratory, medical device, and packaging) located in different geographies such as India, USA, France, UK, Belgium, Canada, and China. The team has managed small to large projects.

Infill can conduct effective GMP audits and has good understanding of quality system, material system, facility & equipment system, production system, laboratory control system, packaging and labelling system (encompassing all the six systems of a pharmaceutical cGMP). Also, expertise in evaluation of sterile manufacturing facility and various sterilization processes. The team has experience in facing inspection by various health authorities (US FDA, EU, MHRA, EDQM, WHO, ANVISA etc.).

Infill has completed multiple projects on quality management services from pre-inspection evaluation (of QMS for EU / US FDA / WHO) to post inspection support in addressing inspection observations.

I-Quality Services includes

    1. Designing adequate RP
    2. Facilitate in execution of RP
    3. Facilitate in upgrading system as per Agencies expectations
    4. Pre-inspection audits.
    5. Support in addressing inspectional observations issued by the agency.
    1. Pre-inspection Preparation
    2. Writing Audit Response (inspectional Observation - US FDA 483 /MHRA /EU/WHO/ROW)
    1. GMP training for manufacturing and laboratory persons
    2. Data Integrity
    3. Good Documentation Practices
    1. Mock Audit
    1. GAP Analysis Audit
    2. API Facility
    3. Finished Drug Product Facility
    4. Supplier and Subcontractor Audit