QC Basics

What is Quality Control (QC)?

Quality Control (QC) in pharmaceuticals ensures that raw materials, in-process samples, and finished products meet predefined quality standards. It involves testing for impurities, potency, sterility, and other critical quality attributes.

Objectives of QC

Ensure safety, efficacy, and consistency of drug products.
Prevent contamination, cross-contamination, and impurities.
Maintain compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
Ensure data integrity in testing and documentation.

Key Principles of QC

Accuracy & Precision – Ensuring results are correct and reproducible.
Reliability – Using validated methods and calibrated instruments.
Compliance – Adhering to pharmacopeial standards (USP, EP, JP, IP).
ALCOA+ Principles – Ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, etc.

Types of QC Testing in Pharma

1️⃣ Chemical & Analytical Testing (QC ANALYTICAL OR CHEMICAL)

Assay & Potency Testing – Measures active pharmaceutical ingredients (APIs).
Impurity Profiling – Identifies and quantifies impurities.
Dissolution & Drug Release – Determines drug absorption and efficacy.
pH, Conductivity, Osmolarity – Critical for injectable formulations.

2️⃣ Microbiological Testing (QC MIROBIOLOGY)

Sterility Testing – Ensures no viable microorganisms are present.
Bacterial Endotoxin Testing (BET) – Detects endotoxins in sterile products.
Environmental Monitoring (EM) – Air, surface, and personnel monitoring in cleanrooms.
Growth Promotion Test (GPT) – Validates media performance for microbial growth.

3️⃣ Physical Testing

Hardness, Friability & Disintegration – Tablet quality parameters.
Particle Size Analysis – Ensures uniformity in suspensions and powders.
Viscosity & Density – Important for liquid formulations.

4️⃣ QC for Biologics & Injectables

Biologics and sterile injectables require stringent QC measures due to their complexity and sensitivity.

🔬 QC Testing for Biologics (Vaccines, Monoclonal Antibodies, Cell & Gene Therapies)

Sterility & Mycoplasma Testing – Critical for contamination control.
Endotoxin & Pyrogen Testing – Detects bacterial toxins.
Potency Assays – ELISA, Western Blot, Flow Cytometry for biologics.
Host Cell Protein (HCP) & DNA Residue Testing – Ensures purity of biologic drugs.
Aggregation & Particulate Testing – Detects protein aggregation in injectables.

💉 QC for Sterile Injectables

Container Closure Integrity Testing (CCIT) – Ensures sterility of vials/syringes.
Osmolarity & pH Testing – Important for injectable formulations.
Particulate Matter Testing – USP <788> requirements for IV solutions.
Stability & Cold Chain Monitoring – Biologics require controlled storage conditions.

5️⃣ QC Virology

🔬 Importance of QC in Virology

QC Virology ensures the safety, potency, and purity of virus-based products such as viral vaccines, gene therapy vectors, and viral-based biologics. This involves strict testing for viral contamination, genetic integrity, and potency.

🦠 Key QC Virology Tests

Sterility & Mycoplasma Testing – Ensuring virus production is free of contaminants.
Viral Titer Assays – Quantification of viral particles using TCID50, Plaque Assay, qPCR, or Flow Cytometry.
Adventitious Virus Testing – Detecting unintended viral contaminants using cell culture or NGS (Next-Generation Sequencing).
Identity Testing – Confirming viral strain identity via RT-PCR or sequencing.
Infectivity & Potency Assays – Evaluating virus replication efficiency and functionality.
Residual DNA & Host Cell Protein Testing – Ensuring no host cell contamination.
Biosafety & Cytopathic Effect (CPE) Testing – Checking for virus-induced toxicity in cell culture.
Stability Studies – Ensuring virus viability under storage conditions.

QC Compliance & Regulations

Good Manufacturing Practices (GMP) – Ensures quality at all stages.
Good Documentation Practices (GDP) – Ensures accurate records.
Regulatory Guidelines – Compliance with USFDA, WHO, ICH, and EMA.

QC Laboratory Best Practices

Use validated analytical methods for all tests.
Maintain a controlled environment to prevent contamination.
Train personnel on GMP, aseptic techniques, and data integrity.
Implement trend analysis and Out of Specification (OOS) investigations.