Chapter 1 Lecture Quality Control

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Transcript Chapter 1 Lecture Quality Control

MANUFACTURING OF PHARMACEUTICALS
Roselyn Aperocho-Naranjo
USPF-College of Pharmacy
[email protected]
www.roselynnaranjo.vze.com
Chapter 1
ORGANIZATIONAL CHART OF A MANUFACTURING COMPANY
BOARD OF DIRECTORS / TRUSTEES
PRESIDENT
VICE-PRESIDENT
GENERAL MANAGERS
Personnel
Department
Coordinates
Finance
Department
Marketing
Department
Technical
Director
Plant
Department
Cost Accounting
Market Research
Research & Product
Development
Production
Labor & Warehouse
Budget
Sales & Detailing
Management
General Accounting
Relationship
Advertising
Quality Control of
Drugs
& Cosmetics
Manufacture of
Pharmaceuticals
Maintenance
ORGANIZATIONAL CHART OF A PLANT DEPARTMENT
PRODUCTION CONTROL DIVISION
Planning & Scheduling
Section
Purchasing Section
Inventory Section
WAREHOUSE DIVISION
Raw Materials
In-process section
Finished Goods
Returned Goods
Dispensing
Section
ORGANIZATIONAL CHART OF A PLANT DEPARTMENT
WAREHOUSE DIVISION
Raw Materials
Quarantine Area
Approved for Use
Rejected Goods Area
PRODUCTION / MANUFACTURING DEPARTMENT
Extractives
Liquids
Tablets, Capsules
Parenterals, Ophthalmic
Medicated Application
Powders, Aerosols
MANUFACTURING OF PHARMACEUTICALS
CLASSIFICATION OF PHARMACEUTICALS
MEDICATED APPLICATIONS
Ointments
Cataplasm (Poultices)
Cements
Ceratose
Creams
Dressings
Pastes
Plasters
Suppositories
LIQUIDS
Solutions
Emulsions
Suspensions
EXTRACTIVES
Tinctures
Fluid Extracts
Extract
Resins
Oleoresins
POWDERS & AEROSOLS
TABLES, CAPSULES AND PILLS
PARENTERALS AND OPHTHALMIC SOLUTIONS
Oral
Dentifrices
Douche
Dusting Powders
Insufflations
QUALITY CONTROL
- Is the combination of attributes or characteristics of a
product, which can be comparable to the standards that
serves as the basis for measuring the uniformity of its
content and determines the degree of acceptability.
- Is a tool that gives the assurance that the product conforms
to the standards and specifications through a system of
inspection, analysis and action.
- Built-in and produced, cannot be inserted into a product
- Produce and deliver a safe, pure and effective product to
the end user.
QUALITY CONTROL
• it minimizes or eliminates
the risk of marketing unsafe
products
• reduces operating
cost and losses
• motivates pharmaceutical and
medical professions to sell
prescribe the product
• guarantees
conformances to
regulatory requirements
• guarantees
product efficacy
• produces higher
employee morale
QUALITY CONTROL
- Can be interpreted
by descriptive words
or measurements
- Quality control variation will
encourage the proliferation of
errors, which may be the
cause of producing a defective
product.
- Errors may be due to 4 M’s
Materials
Methods
Machines
Men
QUALITY CONTROL
FORMULA
RAW MATERIAL SPECIFICATION
- enumerate the characteristics of
all materials to be used in the
product & contain only the
permissible range of purity of
each ingredient.
-Contain a concise
and precise
statement of each
ingredients used in
the products with
the correct weight
and percentage.
STANDARD OPERATING PROCEDURE
- step by step method on the
preparation & manufacturing of a
product, contain all information,
instructions and the acceptable
established range when the product
should be finished.
QUALITY CONTROL
FINISHED PRODUCT SPECIFICATION
- cover all the characteristics that affects the performance of
the product which includes purity, safety and stability.
PACKAGING MATERIAL STANDARD
- include all the packaging used for the product such
as cans, tins, aluminum, caps, labels, cartoons, boxes,
etc.
TESTING METHOD
- a validated and standardized procedure that yields
precision and accuracy of the preparation & manufacturing of
the product handled by different operators and personnel in
the laboratory.
QUALITY CONTROL
- undesirable characteristics of a product due to its failure in conforming
to the standard set of specification.
- refers to a defect found in one or more product.
1. According to its MEASURABILITY
a. Variable defect – can be measured directly by inspection
- length, weight, height, thickness, concentration
volume, viscosity, pH
b. Attributive defect – can be measured by instruments
- detects odor, and visual examinations like color,
clarity, sheen, cleanliness, smoothness, taste
and presence or absence of a characteristics.
QUALITY CONTROL
2. According to SERIOUSNESS OR GRAVITY
a. Critical defect – endanger life or property & may render the
product non-functional.
- absence of warning in label, disintegration time
of an analgesic
b. Major defect – affect the function of the product and render the
preparation useless.
- crack in the bottle, caking of an emulsion
c. Minor defect – does not endanger life nor affect the function of the
product.
- discoloration of the label or box
QUALITY CONTROL
3. According to NATURE
a. Ocular defect – a visible defect
- foreign particles contamination
b. Internal defect – a defect that is not seen
- a sub-potent drug product
c. Performance defect – a defect in function
- suppository that does not melt at body
temperature
QUALITY CONTROL
Sources of Variation
Materials
Example
a.
b.
c.
b.
c.
Variation of equipment for the same
process
Differences adjustment of equipment
Aging and improper care
Methods
a.
b.
c.
Inexact procedures
Inadequate processes
Negligence by chance
Men
a.
b.
c.
Improper working conditions
Inadequate training and understanding
Dishonesty, fatigue and carelessness
Machines
a.
Variation between supplies of same
substance
Between batches from same supplier
Within a batch
QUALITY CONTROL
Materials Inspection Section
Analytical Laboratory
Biological Testing Laboratory
Specifications & Analytical Development
Quality Coordinating Office
QUALITY CONTROL
Materials Inspection Section
Analytical Laboratory
Biological Testing Laboratory
Specifications & Analytical Development
Quality Coordinating Office
QUALITY CONTROL
Materials Inspection Section
(are placed in area of operation, warehouse, manufacturing and packaging sections)
Functions of Inspectors (Inspectors are individual who are experienced,
familiar with the physical characteristics and well versed in sampling technique)
• To sample & examine all raw materials received
• To sample & conduct physical tests on:
•All shipments of packaging materials
• All manufacturing processes such as filling and packaging
operations.
• To maintain periodic examination on the quality of inventories throughout
all phases of storage, shipping and distribution
•To perform an audit which is dependent on the work done by production
personnel
QUALITY CONTROL
Materials Inspection Section
Analytical Laboratory
…to be continued next meeting
Prepare ½ crosswise for a short quiz
Good Luck!
QUALITY CONTROL
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