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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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