Useful Pharma Basic Knowledge

Pharmaceutical Documentation and Guidelines

• Links to GMP-Regulations
• Pharmaceutical Regulatory Agencies in the World
• 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)

• Product Quality Review (PQR) or Annual Product Quality Review (APQR)

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

• White paper on Prevention of Contamination and Cross-Contamination in shared Pharmaceutical Manufacturing Facilities

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