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Batch Certification, Analytical Lab Services and Compliance

This Group supports our clients in the assessment and gap analysis in the following areas:

  • QA Documentation Review that includes review of all policies, guidelines and procedures, including change control, preventive maintenance, and calibration. This also includes review of complaint handling procedures.
  • Raw Material Inspections (Inspection, testing, manufacturing equipment including packaging utilities) including inspection/review of systems and equipment qualifications such as IQ, OQ, PQ and cGMP.
  • Assessment of Process Equipment and Related Utilities that include manufacturing systems and packaging equipment, and utilities.
  • Incoming Material /Product Release Batch Records that include review of incoming material inspection and testing process. Also, complete review of batch records and product release procedures.
  • Laboratory/Methods Development that includes review of Good Laboratory Practices (GLP) and Method Development Procedures.

The following are the representative services of the group:

  • Product Compliance Assessment
  • Analytical Method Validation
  • Conduct GAP analysis of Vendor Audit Programs
  • Develop Corrective and Preventive Action (CAPA) plan for Vendor Audit Program
  • Conduct audits of domestic and international vendors/suppliers, raw material suppliers, component vendors and contract testing laboratories to ensure compliance with cGXPs and corporate guidelines
  • Conduct Internal Quality Audits
  • QA signatory for review and approval of all GMP-regulated documentation (Validation protocols and reports, batch production records, non-conformance reports and investigations)
  • Issuance of Quality Reports, Site Findings and Recommendations
  • Training of Client Personnel
 
 

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