Shop and download immediately, subscription free, the basic collection of standard operating procedures (SOPs) to ensure your compliance with FDA drug GMP 21 CFR 211 and with UK/EU medicines orange guide, for manufacturing pharmaceuticals, herbals and homeopathic drugs with confidence
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All Pharmaceutical GMP SOPs
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1.0 - Drug Definitions used in 21 CFR 211
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1.1 - Quality Management System (QMS) Overview
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1.2 - Good Manufacturing Practice GMP
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1.4 - Product Quality Review (PQR)
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1.6 - Good Distribution Practice GDP
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1.7 - Self Inspection via Internal Audits
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2.1 - Production & Quality Management
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3.0 - Buildings and Facilities Overview
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3.2 - Buildings and Facilities - Laboratory
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3.3 - Buildings and Facilities - Holding and Distribution
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3.4 - Buildings and Facilities - Pest Control
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5.1 - Supplier Approval and Control
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5.2 - Materials - Receipt and Storage
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5.3 - Materials - Sampling and Testing
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6.1 - Prevention of Cross-Contamination
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6.2 - Production - Manufacturing Operations
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6.3 - Production - Packaging and Labeling Operations
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7.0 - Holding and Distribution Overview
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7.1 - Outsourced Wholesale Distribution
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8.2 - Laboratory Controls - Sampling
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8.3 - Laboratory Specifications
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8.4 - Laboratory Controls - OOS Investigation and Form
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8.5 - Laboratory Controls - Physical and Chemical Testing
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8.6 - Laboratory Controls - Microbiology Testing
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8.7 - Laboratory Controls - Stability Testing
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8.8 - Laboratory Controls - Method Validation
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9.0 - Retention Requirements of GMP Records and Reports
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9.1 - Records and Reports - Production Records
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9.2 - Records and Reports - Laboratory Records
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9.3 - Records and Reports - Holding and Distribution Records
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9.4 - Records and Reports - Quality Records
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9.5 - Records and Reports - Complaints Files
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10.0 - Returned and Salvaged Drug Products
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10.2 - Outsourced GMP Activities
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