Pharmaceutical Quality Control

Introduction

Dr. Sultan Alkaleh

Quality:

the totality of features and characteristics of a product or service that bears its ability to satisfy stated or
implied needs.
Product matching with what is the decision of the product, which was developed to meet consumer
demands and needs of the specification

Focus on:
- Product: Specifications, freedom from deficiencies.
- Customer: requirements

Define (what is Q.C).

Operational laboratory techniques and activities used to fulfill the requirement of

quality.
.

Objectives or important (why Q.C ?).

To Improve the following

I-Healthy (Patients):
1 Safety

A poor quality medicine may contain toxic substances that have been
accidentally added.

2 Efficacy

A medicine that contains little or none of the state ingredient will not have
the intended therapeutic effect.

3 Quality: crud mater(synthesis),etc. ( quality safety and efficacy)

4 Stability: by temp, moisture,etc.

II-Economically (Commercially):

Export: helps improve pharmaceutical export opportunities

Import & Sale : Most countries will only accept import and sale of medicines
that have been manufactured to internationally recognized GMP.
1

Pharmaceutical Quality Control

Dr. Sultan Alkaleh

Sciences that associate with Q. C

- Medicinal chemistry

- Analytical chemistry
- Industry pharmacy

- Pharmaceutics,..etc.

General Application of Q.C

Medicinal
Food
Chemically
Industry ,etc.

Aims of students from Course:

Aim you from study of Q.C OR What you need from Study of Q.C?
1- Learning To development.
2- Degree To development.

3- Functionality To development of skills

-Determine the Aim from Course Learning & Degree

-Avoid absence (Persevere on Present) Learning & Degree

-Reading the lecture in the same day learning & Degree

-Self education by more reading learning, Skills & or degree

Note:

-Should be Remember each teacher has his style or way in teaching.

-doesn't you try researching this information's from any book, you are not
found it, because this from my style

To Know education sweet, you assay the ignorance

Pharmaceutical Quality Control

Dr. Sultan Alkaleh

Introduction About Pharmacopoeias

Define :

The word pharmacopeia has its origin in Greek language -Pharmako: meaning drugs
and Poeia: meaning make

Pharmaco poeia

Drugs

Make

Making of Drugs

Is an book which issue by officially health institutions in the countries and contains all drugs
which allowed use, also its specifications, characteristics & preparation methods.

. Pharmacopeia
.

Tune from :

- Group drug
- Index in the final
- Tables For drugs classification from:
- Toxicity: Group (A)

- Density
- Weights

- Anesthetic: Group (B)

- Risk: Group (C)

Common Pharmacopoeia:
- United State Pharmacopoeia ( USP)
- British Pharmacopoeia (BP)

- International Pharmacopeia (IP)

- European Pharmacopoeia (EP)
- France Pharmacopoeia (FP)

Pharmaceutical Quality Control

Dr. Sultan Alkaleh

Contents of Pharmacopoeia ( What we find in the Pharmacopeia?)

No
Subject
1 Scientific name
2

Description

3
4

Solubility
Stability

5
6

Comment

Formula.
Color, odor & Tate.
Onset time.
Properties.
Some chemical information's.

Physical: (change in shape with remain the efficacy)

Pharmacy:
Incompatibility
Drugs: (Synergism or antagonism)
Indications.
Use
Contraindications.
According to:
Age.
Gender.
Disease
Dose
Uses:
- Therapeutic dose
- Prophylactic dose
Storage &
Packaging
http://www.arabsciencepedia.org/wiki/_

Reference:
- IP: http://www.egylovers.net/vb/showthread.php?t=49778

- BP: http://www.kutubpdf.net/book/1626-british-pharmacopoeia-2011---.html

Pharmaceutical Quality Control

Dr. Sultan Alkaleh

Medicine Quality
Define :
Desired characteristics of product to ensure:
Safety
Efficacy
Quality
Stability

Background
-

1990: 236 Children Died In Bangladesh .

1990: 40 Children Died In Nigeria Diethylene Glycol.
1995: 88 Children Died In Haiti
2006: 116 Died In Panama
2009: 24 Died In Bangladesh
Paracetamol elixir, Cough Syrup Glycerol adulterated With Diethylene Glycol.

USP and Glycerin

Glycerin revision (official May1,2009) includes

a Limit test for both Diethylene Glycol (DEG) and Ethylene Glycol (EG) at1.10% each in the Identification test

Official monograph and reference standard information posted on the USPC website:

Building
1-The building should be provide adequate space the placement of materials and equipment any
risks of mix-ups or cross contamination between the drugs, excipients, packaging, labeling.
2-Adequate lighting, ventilation, dust control, temperature and humidity, bacteriological control should be
provided.

Equipment
The equipments should be of suitable size, accuracy, reproducible, their surface should be
inert, nonreactive, non-absorptive.
It should be constructed to facilitate adjustment, cleansing, and maintenance.

Personnel
Qualified personnel should be employed to supervise the formulation, processing,
sampling, testing, and labeling of the drug product.
The operating personnel should have the necessary authority to sign the manufacturing
document for each process.

Determinants of Medicine Quality

Identity: Active ingredient

Purity: Not contaminated with potentially harmful substances
Potency: Usually 90110% of the labeled amount
Uniformity: Consistency of color, shape, size
Other Specifications: polymorph, particle size, dissolution.
Bioavailability: Interchangeable products?
Stability: Ensuring medicine activity for stated period
Identity, purity, potency, uniformity are defined in pharmacopoeias and stated in certificate of analysis (COA)

Excipients, inactive or inert materials

May influence the quality of the products
Affecting the physical properties of the dosage form
Influencing the production process
Excipients is examined carefully and critically for compliance with established standards.
Excipients must clearly identified and supplied in clean and properly sealed containers

Pharmaceutical Quality Control

Dr. Sultan Alkaleh

Control of record
Master formula and batch production records should be prepared and maintained in accordance with
established procedures
Master formula records shall be prepared, endorsed and dated by a competent and responsible individual
and shall be checked, endorsed by another competent and responsible individual

Quality control before start-up:

Personal
Floor, walls, ceiling
Adequate ventilation, Temp. , humidity
Lighting, dust control
Bacteriological control
Water supply
Equipments

Quality control at start up:

Raw materials processing
Compounding
Packing material control
Labels control
Finished product control

Packaging and printed materials:

It includes the primary container components: closure and container and secondary
components such as labels, inserts, and cartons
Labels, inserts, cartons, brochures and boxes are considered as printed supplies
The importance of adequate packaging controls is pointed out by a review of the FDA listing
of product recalls, in which more than 50% is due to improper labeling

Impacts of Low-Quality Medicines

Causes
Materials
Manufacturing process
Packaging
Transportation
Storage condition

impacts
Lack of therapeutic effect which leads to
Prolonged illness and Death
Toxic and adverse reaction
Waste of limited financial resources
Loss of credibility

Types of Quality Problems (Q.C problems):

Mislabeled drugs
Inaccurate or unreadable product labels / labeling
Sterile containers or vials thatare punctured or
Packaging or product mix-ups
Abnormal odor or taste
Capsule leakage
Chipped, cracked, or splitting tablets
Tablet or capsule discolorations
Broken, cracked, or chipped syringes
Suspected product contamination
Vials with foreign floating objects or growth
Container closure defects leaking vials