PHARMACEUTICAL SOP DATABASE
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๐Ÿ“š IAM PHARMACIST โ€ข PHARMACEUTICAL SOP LIBRARY

SOP Database

Browse pharmaceutical Standard Operating Procedures department-wise, category-wise and subcategory-wise. Open an SOP online or download it as a Word document.

8+Departments
105+Categories
64+Subcategories
4+SOP Topics

Browse by Department

Each department has its own categories, subcategories and SOP topics.

Showing all departments
๐Ÿ”ฌ

Quality Control

Analytical testing, laboratory operations and QC procedures

12 Categories
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01
๐Ÿ“Œ
Pharmaceutical Analysisassay, identification, impurities and quantitative analysis
0 Subcategories โ€ข 0 Topics โ€ข 2 Published
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02
๐Ÿ“‘
HPLC & Chromatographychromatographic procedures and troubleshooting
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
03
๐Ÿ”ง
Analytical Method Validationaccuracy, precision, specificity, linearity and robustness
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
๐Ÿ“Š
Dissolution Testingdissolution apparatus, methods and acceptance criteria
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
05
๐Ÿงฐ
Disintegration & Physical Testsdisintegration, hardness, friability and physical tests
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
06
โฑ๏ธ
Stability Testingstability testing and monitoring procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
07
๐Ÿ”ง
OOS & OOT Investigationout-of-specification and out-of-trend investigations
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
๐Ÿ”ง
Sampling & Testingmaterial and product sampling procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
โš—๏ธ
Reference Standardsprimary, secondary and working standards
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
10
๐Ÿ“Š
Calibrationlaboratory equipment calibration procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
11
โš—๏ธ
Laboratory Practices / GLPlaboratory safety, GLP and documentation
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
12
๐Ÿ“Š
Data IntegrityALCOA+, audit trails and laboratory records
0 Subcategories โ€ข 0 Topics โ€ข 1 Published
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๐Ÿ›ก๏ธ

Quality Assurance

Quality systems, compliance, deviations and CAPA

9 Categories
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01
๐Ÿงฐ
GMP & Quality SystemsGMP, quality systems and compliance procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
02
๐Ÿ”Ž
Deviations & Investigationsdeviation reporting, investigation and root cause analysis
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
03
๐Ÿงฐ
CAPAcorrective and preventive action management
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
๐Ÿ“‘
Change Controlcontrolled changes to processes, equipment and documents
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
05
๐Ÿ”Ž
Audits & Self-Inspectioninternal audits, inspections and follow-up
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
06
๐Ÿ“Œ
Product Recallproduct recall and market withdrawal procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
07
โš—๏ธ
Batch Documentationbatch records and quality documentation
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
โš—๏ธ
Validation & Qualificationvalidation and qualification lifecycle
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
โš—๏ธ
Training & Personnel Qualificationtraining, qualification and competency
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
๐Ÿญ

Production

Manufacturing, processing and packaging procedures

12 Categories
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01
๐Ÿ“Š
Production FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 5 Topics
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02
โš—๏ธ
DispensingStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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03
โš—๏ธ
Blending & Mixingblending, mixing and uniformity procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
โš—๏ธ
Granulationwet and dry granulation procedures
0 Subcategories โ€ข 4 Topics
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05
๐Ÿ“
Compressiontablet compression and machine operation
0 Subcategories โ€ข 4 Topics
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06
๐Ÿ“Œ
Coatingtablet coating procedures
0 Subcategories โ€ข 4 Topics
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07
๐Ÿงซ
Milling & Sievingmilling, sizing and sieving
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
๐Ÿงซ
Tablet Manufacturingtablet manufacturing operations
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
๐Ÿ“
Capsule Manufacturingcapsule filling and manufacturing
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
10
๐Ÿ“‘
Packagingprimary and secondary packaging operations
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
11
๐Ÿ”Ž
Line Clearance & Changeoverline clearance and product changeover
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
12
๐Ÿ“‘
Aseptic & Sterile Manufacturingaseptic processing and sterile manufacturing
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
๐Ÿฆ 

Microbiology

Sterility, microbial testing and environmental monitoring

10 Categories
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01
๐Ÿ“Œ
Microbiology FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 5 Topics
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02
๐Ÿ”Ž
Sterility Testingsterility testing procedures
0 Subcategories โ€ข 4 Topics
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03
โš—๏ธ
Microbial Limit Testingmicrobial limit testing
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
๐ŸŽฏ
Bioburdenbioburden testing and monitoring
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
05
๐Ÿงซ
Microbial LimitsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 3 Topics
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06
โš—๏ธ
Bacterial Endotoxin Testbacterial endotoxin testing
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
07
๐Ÿงฐ
Environmental Monitoringenvironmental monitoring programs
0 Subcategories โ€ข 5 Topics
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08
๐Ÿ“‘
Culture Mediamedia preparation, growth promotion and controls
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
๐Ÿงซ
Microbial Identificationmicrobial identification procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
10
๐Ÿ”Ž
Water Microbiologypharmaceutical water microbiology
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
โš™๏ธ

Engineering & Maintenance

Equipment, utilities and maintenance procedures

9 Categories
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01
โš—๏ธ
HVAC & AHUHVAC, AHU and air handling procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
02
๐Ÿ”ง
Engineering FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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03
๐Ÿ”ง
HEPA FiltersHEPA filter inspection and integrity testing
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
๐ŸŽฏ
Preventive Maintenanceplanned preventive maintenance
0 Subcategories โ€ข 4 Topics
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05
โš—๏ธ
Purified Water & Utilitieswater and utility systems
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
06
๐Ÿงซ
UtilitiesStandard Operating Procedures and controlled procedures
3 Subcategories โ€ข 5 Topics
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โš—๏ธ
Water SystemsStandard Operating Procedures and controlled procedures
0 SOPs View โ†’
No SOPs have been published in this subcategory yet.
โš—๏ธ
HVACStandard Operating Procedures and controlled procedures
0 SOPs View โ†’
No SOPs have been published in this subcategory yet.
โš—๏ธ
Compressed Aircompressed air systems
0 SOPs View โ†’
No SOPs have been published in this subcategory yet.
07
๐Ÿ”ง
Electrical Systemselectrical systems and safety
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
โš—๏ธ
Generatorsgenerator operation and maintenance
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
โš—๏ธ
Breakdown Maintenancebreakdown and corrective maintenance
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
๐Ÿ“ฆ

Warehouse

Material receipt, storage, sampling and dispensing

11 Categories
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01
๐Ÿ“
Raw Materialsreceipt, storage and handling of raw materials
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
02
โš—๏ธ
Warehouse FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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03
โš—๏ธ
Packaging Materialsreceipt, storage and control of packaging materials
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
04
๐Ÿงซ
Material ReceiptStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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05
โš—๏ธ
StorageStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 5 Topics
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06
โš—๏ธ
Sampling & Dispensingsampling, dispensing and material issue
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
07
๐Ÿ“Š
Storage Conditionstemperature, humidity and storage requirements
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
๐Ÿ“
Temperature Mappingwarehouse temperature mapping
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
๐Ÿ”ง
Rejected Materialsrejected and quarantined materials
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
10
๐Ÿงซ
Finished Goodsfinished goods storage and handling
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
11
โš—๏ธ
Dispatchfinished product dispatch procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
๐Ÿงช

Research & Development (R&D)

Formulation, analytical development and technology transfer

9 Categories
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01
๐Ÿ“Š
Preformulationpreformulation studies and characterization
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
02
๐Ÿงซ
R&D FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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03
โš—๏ธ
Formulation Developmentformulation development procedures
0 Subcategories โ€ข 5 Topics
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04
๐Ÿ”Ž
Analytical Developmentanalytical method development
0 Subcategories โ€ข 4 Topics
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05
โš—๏ธ
Method Development & Optimizationmethod development and optimization
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
06
โš—๏ธ
Scale-Upscale-up and pilot batch activities
0 Subcategories โ€ข 3 Topics
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07
๐Ÿ”Ž
Technology Transfertechnology transfer procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
๐Ÿ”Ž
Stability Developmentdevelopment stability studies
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
09
๐Ÿ“
R&D Documentationresearch and development documentation
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
๐Ÿ“‹

Regulatory Affairs

Dossiers, submissions and regulatory compliance

8 Categories
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01
๐Ÿ”ง
Dossier Preparationregulatory dossier preparation
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
02
๐Ÿ“Š
Regulatory FundamentalsStandard Operating Procedures and controlled procedures
0 Subcategories โ€ข 4 Topics
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03
โฑ๏ธ
CTD / eCTDCTD and electronic submission procedures
0 Subcategories โ€ข 4 Topics
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04
๐Ÿ“‘
Product Registrationnew product registration
0 Subcategories โ€ข 4 Topics
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05
๐Ÿ“Œ
Variations & Changesregulatory variations and post-approval changes
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
06
๐ŸŽฏ
Renewalsregistration renewal procedures
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
07
๐Ÿ“Š
Regulatory Submissionssubmission planning and management
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.
08
๐Ÿ“
Regulatory Complianceregulatory compliance and commitments
0 Subcategories โ€ข 0 Topics
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No SOPs have been published in this category yet.