Useful Pharma Basic Knowledge
Pharmaceutical Documentation and Guidelines
- Links to GMP-Regulations
- Pharmaceutical Regulatory Agencies in the World
- List of Global Medicine Regulatory Bodies and Brief History
- Pharmaceutical abbreviations
- Eight steps process to effectively sanitize hands
- Good Documentation Practice and Document Control in Pharmaceuticals
- All about pharmacopoeia
- Standard Operating Procedure (SOP) handling of waste paper generated during documentation in the pharmaceuticals
- Standard Operating Procedure (SOP) procurement, use destruction, and management of stamps in the pharmaceuticals
Quality Management System
- Change Control Program or Change Management System
- Deviation/ non-conformance management and Quality Risk Management
- Standard Operating Procedure for Site Master File (SMF)
Investigation and statistical tools
- Fishbone or cause-and-effect diagram
- Investigation, Corrective and Preventive Action (CAPA)
- Process Capability Indices (Cp, Cpk, Pp, Ppk) and Free Excel Sheet
- Statistical-Tools-and-its-Application
Pharmaceutical Manufacturing
- Calculation of Rapid Mixture Granulator impeller and chopper speed during wet granulation process scale-up
- Simple methods to determine powder flow property -Angle of repose, Compressibility index and Hausner ratio
- Most common 18 tablet defects at compression stage
- Most common 14 tablet defects at coating stage
- All about tablet tooling
- Dwell Time Calculation – impact on tablet manufacturing
- 15 Types of Solid Dosage Forms, definitions, advantages, and route of administration
Good Distribution Practice (GDP)
- Mean Kinetic Temperature and Temperature Excursions
- Thermal Cycling Study and Temperature Excursions
- Standard Operating Procedure for receipt of raw materials in warehouse
- Standard Operating Procedure for receipt of packing materials in warehouse
Quality Control guidance
- Dissolution Profile Comparisons, F1 and F2
- Acceptance Value for Uniformity of dosage units test as per USP chapter <905> Uniformity of dosage units test
- White paper: Pharmaceutical Reduced Testing for the 21st Century – Risk based approach for Skip lot or Periodic Testing of Starting Materials in Pharmaceuticals
- Complete guide: High Performance Liquid Chromatography (HPLC) – History, Definition, Principle, Types, Instrumentation, and Applications
- Comparison of FDA OOS guidelines October 2006 and May 2022
Annual Product Quality Review (APQR/ PQR)
Audit and compliance
- GMP and Regulatory Inspections – Practical advice for preparation and readiness
- Code of conduct during regulatory inspection in pharmaceutical facilities
Pharmaceutical engineering
- Filters for Heating, ventilation, and air conditioning (HVAC) system
- Identification of Stainless Steel SS 202, SS 304 and SS 316 using electrolyte detection of Molybdenum
- Standard Operating Procedure (SOP) for Preparation and management of Drawings and Layouts
- Standard Operating Procedure (SOP) for verification of clock time and time harmonization
Cross-Contamination
Pharma SOPs
- Standard Operating Procedure for Warehouse
- Standard Operating Procedure for Human Resource and Administration
Drug Development
- First step of document to a generic drug development department – SOP for a generic development department
- Essentials of Development Notebook for pharmaceuticals
- Helpful 19 points ANDA Pre-formulation Checklist and Regulatory Aspects
