Qualification & validation Granulation, blending & compression validation Blend and content uniformity, compression and coating consistency. Dissolution method development & validation Method, validation and profile comparison for oral solids. Hold-time and in-process stability studies Bulk granules, cores and solutions, held and proven. Preservative efficacy & microbial limits Antimicrobial effectiveness and water control for non-sterile products. ICH Q7 gap assessment for active ingredients API manufacture assessed against the standard written for it. Validation Master Plan Site validation strategy and sequencing. Equipment, facility & utility qualification DQ, IQ, OQ, PQ and periodic requalification. Process validation Prospective, concurrent and continued process verification. Cleaning validation Worst case selection, MACO, health-based limits, recovery. Media fill design & rationale Intervention matrix and worst-case justification. Sterilisation & depyrogenation cycle validation Moist heat, dry heat and filtration. Analytical method validation & transfer Between laboratories, sites or contract partners. Computerised system validation CSV and the risk-based CSA approach. Compliance & inspection Contamination control strategy — non-sterile The document Schedule M expects, written for a non-sterile plant. Good Distribution Practice & temperature mapping Storage, transport and the records that prove the chain held. Revised Schedule M gap assessment Clause by clause, with a costed remediation roadmap. Mock inspection & audit readiness CDSCO, State FDA, WHO-GMP, EU-GMP, US FDA and PIC/S. Observation and Form 483 response Root cause, CAPA plan and closure evidence. Customer and vendor audit support Hosting the audit, and answering what follows. Self-inspection programme design So the site finds its own gaps between audits. Data integrity assessment ALCOA+ across instruments, logbooks and spreadsheets.
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