Supplier Auditing

  • We perform both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management programme. In addition, investigative audits following process concerns are also undertaken.
  • We perform API and finished products manufacturers’ audit to check compliance with ICH,EU GMP,US FDA ,WHO GMP ETC.

PREPARING MANUFACTURING SITES FOR EU/PICs/US FDA, WHO GMP:

  • Normally we start a project by performing a GAP Analysis. This GAP Analysis will inform the clients about the current GMP situation of the facility concerned. The length of the audit depends on the complexity of the manufacturing site and the number of products. We perform a comprehensive analysis of the documents available at the manufacturing site before the audit will be performed, e.g. Site Master File, certain SOPs, Validation Plan, batch Record etc. As a result of the document analysis and the GAP inspection on site a comprehensive report will be developed which contains a to-do list and a GAP analysis Normally we continue the support after the audit by managing the project list. This means that our experts will manage the oversight over the project plan and monitors the milestones of the project.
  • On request our experts prepare certain GMP documentation for the clients, e.g. SOPs, Validation Master Plan etc. We support clients by contacting the relevant competent regulatory authority in charge of the marketing authorization or of the manufacturing authorization.

COMPUTERIZED SYSTEM VALIDATION:

  • We provide complete validation suite for automated manufacturing practices used in pharmaceutical industries. Having exceptional Exposure to various processes and undertaken several automation, Software & validation projects of the automated manufacturing systems makes us proficient to take care of validation requirements and US FDA21CFR Part 11 related issues. We use an efficient systematic, risk based, quality system approach to developing protocols. We also employ a very pragmatic approach to protocol execution, which allows us to fulfill all regulatory documentation requirements efficiently and with minimum of delay and with a minimum of interference with our customer’s operations. We have distinctive expertise in validation documentation and validation implementation. Following key services includes:
    • Laboratory Information Management System (LIMS) validation.
    • Custom Database and spreadsheet development and validation.
    • HPLC, GC, SAS, LCMS, Chromatography software validation including configuration and validation of network data systems.
    • Preparation of validation master plans.
    • Development of requirement specifications, documentation, traceability matrices and other GAMP documentation. ERP /SAP validation.

QUALIFICATION AND VALIDATION:

  • We help in preparation of following:
    • Validation master plan
    • Risk assessment plan
    • Qualification and validation protocols like DQ, IQ, and OQ, PQ
    • Qualification of utility systems, process validation, cleaning validations HVAC system validation.
    • Preparation of validation summary reports.