Pharmaceutical QC & Lab Concepts – Complete Guide

Pharmaceutical jobs, especially in Quality Control (QC), Quality Assurance (QA), and R&D, require a clear understanding of laboratory principles, regulatory standards, and analytical techniques. This guide consolidates key concepts, definitions, tests, and principles into one post for easy reference.

Common Full Forms in Pharma

• OOS – Out of Specification

• CAPA – Corrective and Preventive Action

• DGDA – Directorate General of Drug Administration

• cGMP – Current Good Manufacturing Practice

• USP – United States Pharmacopoeia

• BP – British Pharmacopoeia

• ISO – International Organization for Standardization

• IEC – International Electrotechnical Commission

In Vitro vs In Situ Reactions

• In Vitro: Reactions performed outside living organisms, e.g., in test tubes.

• In Situ: Reactions performed in their natural environment without removal.

Spillages & PPE in Pharma Labs

• Spillages: Handled with spill kits to prevent contamination and hazards.

• PPE (Personal Protective Equipment): Gloves, goggles, lab coats, and masks protect personnel from chemical, biological, and physical risks.

Spill Kits:

• Chemical Spill Kit: For acids, bases, and solvents. Contains neutralisers, absorbents, gloves, goggles, and disposal bags.

• Biological Spill Kit: For infectious materials. Contains disinfectants, absorbents, biohazard bags, and PPE.

• Oil Spill Kit: For oils and hydrocarbons. Contains oil-only absorbents, booms, and disposal containers.

• Universal Spill Kit: For mixed/unknown spills. Contains general absorbents, PPE, and disposal bags.

HPLC (High Performance Liquid Chromatography)

• Principle: Separation occurs due to differential partitioning between the liquid mobile phase and the stationary phase.

• Applications: Drug assay, impurity profiling, stability testing, food & biological analysis.

GC (Gas Chromatography)

• Principle: Separation based on boiling point and volatility differences.

• Carrier Gas: Helium (most common), Nitrogen, or Hydrogen.

• Applications: Analysis of volatile compounds, solvents, fragrances, and environmental samples.

Other Chromatography Principles

Physical & Chemical Tests for Solid Tablets

• Physical: Appearance, weight variation, hardness, friability, thickness, disintegration, dissolution.

• Chemical: Assay, impurity profiling, identification, and content uniformity.

QA vs QC

• QA (Quality Assurance): Process-oriented, preventive, ensures compliance with cGMP.

• QC (Quality Control): Product-oriented, detects deviations, ensures finished product quality.

Limit Test

A semi-quantitative test used to detect small amounts of impurities within predefined limits (e.g., chloride, sulfate, heavy metals).

Validation

Ensures that equipment, processes, and methods consistently produce results that meet predetermined quality standards.

Disintegration vs Dissolution

• Disintegration: Time required for a tablet to break into particles.

• Dissolution: Rate & extent of drug release into solution for absorption.

OOS vs Deviation

This guide provides a complete reference for pharmaceutical QC, QA, and lab practices. Understanding these concepts is essential for interviews, exams, and real-world lab work.

📌 Stay connected with Chemistry Job Insight for more pharma interview Q&A, analytical techniques, and lab best practices.