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 Quality Control (QC) 

 Intended Learning Outcomes of Course (ILO)
A- knowledge and understanding
- Identify principles of pharmaceutical analysis according to GLP guidelines.
- Recognize basic methods of extraction to identify pharmacologically active principles of medicinal
and degradation products employing chromatographic , electrochemical , spectroscopic methods.
- Distinguish the fundamentals of pharmaceutical manufacturing according to cGMP guidelines,
including different methodologies , unit operations , unit processes and quality control procedures.
- GLP : Good laboratory practice - cGMP : Current good manufacturing practice
B- Professional and practical skills :
- Conduct research studies and analyze the result .
- practice different methods of analysis of raw medicines .
- implement simple practical program to follow up analysis techniques
C- Intellectual skills :
- Select the appropriate methods of identification , analysis and standardization of samples.
- Analyze and interpret experimental results as well as published literature
D- General and transferable skills :
- Work effectively in team - Implement writing and presentation skills
- Demonstrate critical thinking , problem solving and decision making abilities .

 Quality 
- quality is the degree of excellence or freedom from defects or delighting customers
- in pharmacy practice : quality of pharmaceutical product is should be Safe+ effective
- Pharmaceutical chemistry → organic chemistry → Medicinal chemistry → Analytical chemistry →
Applied analytical chemistry → functional group analysis → Quality control
- Quality Control → Research → official & Non official methods → Development (R & D) → Select
analytical technique or method → Adequate → analysis of known sample and unknown →
Comparison statistics → reduce data , interpret and report result → Production → Controlled
Qualified products
- Requirements for methods of analysis :
- Safety , Simple , Rapid , accurate , precise → Controlled Qualified products
- Labs , apparatus , Chemicals , Pharmaceutical preparation Staff and technicians → Controlled
Qualified products
Drug Quality Control
Raw material , safe and effective - detect the defects (QC = quality control)
Medicinal products - Prevent the defects (QA = quality assurance)

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• WHO Definitions •
- Quality : The total characteristics of a medicinal product that ensure its safety and efficacy
- Characteristics and features of drug that determines its quality :
Identity - the correct active ingredient is present
Purity - not contaminated with potentially harmful substances
Potency - the correct amount of active ingredients
Uniformity - Consistency – Color shape and size of the dosage from don’t vary
Bioavailability - Speed and completeness with which a drug enters the blood stream
- Drug bioavailability differs between different manufacturers of similar products.
- Careful evaluation of generic drugs
Stability - The activity of drug is guaranteed for period of time stated until expiration date
• Quality relationships •
1) Quality assurance (QA): put regulations, plan to :
- Put things in place in advance
- Assures quality will be achieved , no problem in quality of final product
2) Good manufacturing practice (GMP) :
- concerned with manufacturing, production and QC matters
3) Quality control (QC): Testing
QA Process Proactive ‫استباق‬ Staff Function defects prevention
QC Product Reactive ‫رد فعل‬ Line function defects detection

Quality assurance - The sum total of all organized arrangements made with objective of
QA ensuring that medicinal products are of quality required for their intended use
Quality Control - it is part of GMP which is concerned with sampling , Specifications , testing
QC and documentation .
GMP - Good manufacturing practice
- It is part of QA which ensures that products are consistently produced and
controlled to the quality standards appropriate to their intended use .
cGMP - current good manufacturing practice regulations (up to date )
TQM - it is the overall intensions and directions of organization regarding quality as
formally expressed and authorized by top management
Total Quality
management - It deals with :
1- Analyzing and improving work processes to ↑ efficiency and reduce waste
2- Designing and establishing quality in products and processes
3- Provide training and placing emphasis on lifelong learning
4- Provide leadership management style → support / cultivate one-team
approach

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 Quality management improvement:
- inspection ( ‫ → ) المنتج‬QC ( ‫ → ) المنتج‬GMP → QA ( ‫ → ) المنتج و العمليات‬TQM & ISO
( ‫ → ) المنتج و العمليات والعاملين‬LSS (lean six sigma) ‫المنتج و العمليات والعاملين والعميل‬
 Elements of Quality assurance cycle in Pharmaceutical manufacturing:
- Research - Development - Prototyping - Documentation - Raw materials
- Facilities , Equipment - personnel and supervision - Monitoring , feedback , follow up
 Quality is not add on :
- Quality must be designed & built into product during research , Development , production
- Product quality criteria must be established , detailed specifications must be provided &
quantitative parameters for measurement
- Written Procedures document how quality is attained and maintained
- Continuous monitoring (sampling and testing 0 to confirm quality is built into product
 Poor Quality medicines :
- health hazard
- waste of money for government and consumers , doesn’t save money in long term .
- contain toxic substance that have unpredictable , unintended consequences.
- Hurt everyone : Patients , health care workers , policy makers , regulators , manufacturers
- The ultimate goal of any pharmaceutical product is to be : Safe , pure , effective
 Primary functions of Quality Assurance :
1- Active pharmaceutical ingredients (API) and non-active material control → sampling , inspecting ,
testing of incoming raw materials
2- inspection control of product , intermediates , operations at critical intermediate stages
• In-process control (IPC) •
- IPC give early warning of conditions which may lead to out of control situation
- IPC allow timely corrective action to be taken before this occur
- IPC levels are more restrictive than final acceptance level
- Sterile products receive the most critical IPC and testing → to ensure that final products is free
from microbial contamination.
3- Quality Control : Analytical testing of products
4- Control of products through its distribution : GDP (Good distribution practice )

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