Medical Devices & cGMP Overview.pptx

1. College of
Nursing
Pharmacy &
Allied
Health
Sciences
UNIT 1. INTRODUCTION TO
PHARMACEUTICAL DOSAGE
FORMS AND DRUG
DELIVERY SYSTEMS
Pharm 200
Pharmaceutical Dosage Forms and Drug
Delivery Systems

2. Department
of
Pharmacy Medical Device
A medical device can be any instrument, apparatus, implement,
machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the
manufacturer to be used, alone or in combination for a medical
purpose. (World Health Organization)

3. Department
of
Pharmacy Uses of Medical Devices (DOH)
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an
injury
• investigation, replacement, modification or support of the anatomy or of a
physiological process,
• supporting or sustaining life
• control of conception
• disinfection of medical devices
• providing information for medical or diagnostic purposes by means of in-
vitro examination of specimens derived from the human body;
• and which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic means, but
which may be assisted in its intended function by such means.

4. Department
of
Pharmacy Classification of Medical Devices
CLASS A – Low Risk (e.g. bandages)
CLASS B – Moderate Risk
CLASS C – Moderate/ High Risk
CLASS D – High Risk (e.g. implantable defibrillators)

5. Department
of
Pharmacy Examples:
Adhesive Bandage (Class A)
Contact lens, including cosmetic
contact lenses (Class B)

6. Department
of
Pharmacy Examples
Condom (Class C) Implantable pacemakers (Class D)

7. Department
of
Pharmacy
Current Good Manufacturing
Practice
This 1999 GMP guidelines is adopted to:
• 3.1 Prescribe standard guidelines in the manufacture of drug products
• 3.2 Ensure that no person or establishment shall manufacture drugs
under substandard conditions.

8. Department
of
Pharmacy Important Terms in cGMP
Good Manufacturing Practice (GMP)
• It is the system of quality assurance aimed at ensuring that products
are consistently manufactured to a quality appropriate for their
intended use. It is thus concerned with both manufacturing and quality
control processes and procedures.
Manufacture or Manufacturing
• The complete set of activities to produce a drug that comprise
production and quality control from dispensing of materials to the
release for distribution of the finished product.

9. Department
of
Pharmacy Important Terms in cGMP
Quality Control
• All control measures taken designed to ensure that finished products
consistently conform to established specification of identity, strength,
purity and quality.
Production
• All operations starting from dispensing of materials to processing,
packaging, to finished product.
Raw Material
• All substances whether active or excipients that are employed in the
processing of a finished product.

10. Department
of
Pharmacy Important Terms in cGMP
Specification of Material
• A description of starting material, intermediate, bulk or finished
product in terms of its chemical, physical and microbiological
characteristics, if any. A specification shall include descriptive and or
numerical clauses stating standards and tolerated deviations,
whenever applicable.
Quarantine
• An act of holding off a material for use, or a product for packaging or
distribution by physically setting it apart or by system duly validated,
pending a decision on release or rejection.

11. Department
of
Pharmacy Important Terms in cGMP
Batch
• A quantity of drug product/device that is homogenous in character and
quality produced during a given cycle of manufacture and from a specific
manufacturing order.
Batch Number`
• A designation in numbers or letters or combination thereof that identifies the
batch, and permits the tracing of the complete history of a batch, including all
stages of its production, control and distribution.
Lot
• A batch or any portion of batch produced by a continuous process, an amount
of drugs produced in a unit of time or quantity in a manner that assures its
uniformity and in either case which is identified by a distinctive lot number
and has uniform character and quality within specified limits.

12. Department
of
Pharmacy Contents of cGMP