Services
GMP Documentation
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Writing of QA, QC, Production, R&D and Corporate QA SOP’s
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Review and revision of existing SOP’s
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Audit to identify need for new SOP’s and prepare new SOP’s
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Preparation and review of packaging material and raw material
specifications Preparation of quality manual and Policy for the company
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Preparation of Safety, health and environment related SOP’s
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Review existing MFR’s and revise to meet regulatory requirements
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Preparation of annual product review and trend analysis
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Preparation and revision of Site Master File
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Preparation and revision of Validation master Plan
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Review and revision of protocols for various types of validations
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Process Validation
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Analytical validation
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Cleaning validation
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Protocols for DQ, IQ, PQ and OQ for equipments
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Other GMP documents
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Review of documents and approvals from regulatory agencies to identify
gaps and non compliances