What is Quality Control?

Quality control (QC) in pharmaceuticals refers to the systematic process of

ensuring that pharmaceutical products meet predetermined standards of
quality, safety, and efficacy.
Importance of QC in pharmaceutical
Industry:
Quality control is crucial in the pharmaceutical industry because it directly
impacts patient safety by ensuring that drugs are consistently manufactured
to the correct standards, are free from contaminants, and possess the
intended potency, effectively minimizing the risk of adverse reactions while
upholding public health and complying with strict regulatory requirements;
essentially, it guarantees the safety and efficacy of every drug produced.
 Quality Control procedure in
Pharmaceutical Industry:
• The quality control (QC) procedure in the pharmaceutical industry
involves a series of steps to ensure that pharmaceutical products meet
predetermined standards of quality, safety, and efficacy. Here’s an
overview of the QC procedure:

1. Raw Material Testing: Verifying the identity, purity, and quality of raw
materials used in production.
2. In-Process Control: Monitoring and controlling the manufacturing
process to ensure that it operates within established parameters.
3. Finished Product Testing: Testing the final product for quality, purity,
and performance.
4. Stability Testing: Evaluating the product’s stability over time to ensure
that it remains effective and safe.
 Quality Control Procedure in
Pharmaceutical Industry:
5. Microbiological Testing: Detecting and identifying microorganisms that
may be present in the product.
6. Packaging and Labeling Control: Verifying that packaging and labeling
meet regulatory requirements.
7. Documentation and Record-Keeping: Maintaining accurate and
complete records of all QC activities.
By following these steps, pharmaceutical companies can
ensure that their products meet the required standards of
quality, safety, and efficacy.
 MONITORING OF QUALITY CONTROL
Monitoring of quality control is done by QMS.
Pharmaceutical Quality Management System (QMS) is a comprehensive collection of policies,
processes, and procedures designed to ensure and maintain uniform and high quality in the
production of pharmaceutical products.
The QMS must reflect the specific needs of the pharmaceutical company and applicable
regulatory requirements.
A robust Pharmaceutical Quality System (PQS) that reflects the applicable requirements can also
help pharmaceutical companies to mitigate risks, improve customer satisfaction, and streamline
quality processes.
The pharmaceutical quality management system includes several processes, such as:
• Document management
• Change control
• Training management
• Audit management
• CAPA management
• Deviation management
Applicable Pharmaceutical QMS Regulations and Standards
• Establishing and working according to the Quality Management System (QMS) is a requirement in
the pharmaceutical industry. To ensure uniform and high-quality products, companies need to
implement a QMS that reflects the requirements applicable to them.
Some of the most common standards and regulations applicable to the
pharmaceutical QMS are described below.
• International Organization for Standardization (ISO)
• Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• ICH Guideline Q10(The International Council for Harmonization of Technical Requirements)
• Current Good Manufacturing Practice (cGMP)
• Food and Drug Administration(FDA 21 CRF PART 210 &211)
Elements of Pharmaceutical Quality Management System
A Pharmaceutical Quality System comprises numerous elements and QMS processes. There is no
“fixed” implementation scheme. The drug manufacturer can integrate these processes as per the
product and intended market requirements.
Some of the elements of the product lifecycle in ICH Q10 are the following:
Stages of Stages of
• Process performance and product quality monitoring system product
lifecycle
Pharmaceutical
product
lifecycle
Commercial
development: manufacturing:

• Corrective action and preventive action (CAPA) system

Technology Product
• Change management system transfer: discontinuation:

• Management review of process performance and product quality

CAPA
FACTORS AFFECTING QUALITY CONTROL
• Good manufacturing practices (GMP)
• Management
• Risk analysis
• Batch stability
• Data integrity guidelines
• Documents
• Good laboratory practices (GLP)
• Machines and methods
• Machines and methods
• Supply chain quality management
PRE-FORMULATION STUDIES:
• Pre-formulation studies are laboratory investigations conducted on a
new drug molecule before developing a final pharmaceutical
formulation.
• These pre-formulation studies help determine factors like solubility,
stability, and compatibility with other ingredients. By understanding
how a drug behaves under various conditions, pharmaceutical
developers can avoid potential issues in later stages.
Importance of Pre-formulation in Drug Safety and Efficacy
• The importance of pre-formulation studies in drug development cannot be
overstated, as they form the foundation for ensuring that a drug product is both
safe and effective before entering clinical trials and mass production. T
OBJECTIVES:
• To establish the necessary physiochemical parameters of a new drug

• To determine drug kinetic rate profile

• To develop a stability indication assay

• To establish drug compatibility with common excipients

• It provides insights into how drug products should be processed and stored to
ensure their quality.
MAJOR AREAS OF PRE-FORMULATION STUDIES:
• ORGANOLEPTIC CHARACTERS
• BULK CHARACTERS • STABILITY ANALYSIS
CRYSTALLINTY AND POLYMORPHISM  STABILITY IN TOXIC FROMULATIONS
HYGROSCOPICITY  SOLUTION STABILITY
FINE PARTICLE CHARACTERIZATION  PH RATE PROFILE
 BULK STAIBILTY
POWDER FLOR PROPERTIES
 COMPATIBILTY
• SOLUBILITY ANALYSIS  SOLD STATE STABILITY
IONIZATION CONSTANT-PKa
pH SOLUBILTY PROFILE
THERMAL EFFECTS
SOLUBILAZATION
DISSOLUTION
COMMON ION EFFEC-Ksp
Pharmaceutical
Quality Testing
A "testing program in pharmaceutical quality
management" refers to a systematic process within a
pharmaceutical company where samples of raw
materials, in-process materials, and finished products are
collected and rigorously tested at various stages of
production to ensure they meet established quality
specifications, including potency, purity, and stability,
thus guaranteeing the safety and efficacy of the final
drug product, all while adhering to regulatory standards
like cGMP (Current Good Manufacturing Practices
Pharmaceutical quality control involves a series of steps
to ensure pharmaceutical products' safety, efficacy, and
consistency. These steps are critical in meeting regulatory
requirements and maintaining product quality. Here is an
overview of the typical steps involved in pharmaceutical
quality control:
Steps in Pharmaceutical Quality Control
Sampling
 Types of testing processes:

Different types of testing within a pharmaceutical quality

management system:
1. Raw Material Testing:
Analyzing incoming raw materials for identity, purity, and
potency before they are used in production.
2.In-Process Quality Control (IPQC):
 Monitoring critical process parameters during manufacturing
 Sampling and testing at different stages of production
 3.Finished Product Testing:
 Conducting comprehensive analysis on the
final drug product to confirm it meets all
quality standards before release.
 4. Microbiological Testing:
 Performing tests to check for the presence of bacteria,
fungi, and other microorganisms in sterile products.
 Stability testing protocols:

 Study designs to evaluate the stability of a drug
product over time under different storage
conditions, including parameters like potency,
appearance, and impurities.
Analytical Techniques Used in Pharmaceutical Quality
Control:
1. High Performance Liquid Chromatography (HPLC)
2. Gas Chromatography (GC)
3. Mass Spectrometry (MS)

4. Ultraviolet-Visible Spectroscopy (UV-Vis)

5. Infrared Spectroscopy (IR)
6. Atomic Absorption Spectroscopy (AAS)
Importance of a robust testing program:

Patient safety: Ensuring that only high-quality drugs

are released to the market, minimizing risks to
patients.
Regulatory compliance: Meeting the requirements
set by regulatory agencies like the FDA or EMA.
Product consistency: Maintaining consistent
quality across different batches of a pharmaceutical
product.