MANUFACTURING OF PHARMACEUTICALSChapter 1

Roselyn Aperocho-NaranjoUSPF-College of Pharmacyrose_may26@yahoo.com

www.roselynnaranjo.vze.com

BOARD OF DIRECTORS / TRUSTEES

Finance Department

Plant Department

Personnel Department

Marketing Department

Technical Director

Coordinates

Labor & Warehouse

Management

Relationship

Cost Accounting

Budget

General Accounting

Market Research

Sales & Detailing

Advertising

Research & Product Development

Quality Control of Drugs

& Cosmetics

Production

Manufacture of Pharmaceuticals

Maintenance

PRESIDENT

VICE-PRESIDENT

GENERAL MANAGERS

ORGANIZATIONAL CHART OF A MANUFACTURING COMPANY

ORGANIZATIONAL CHART OF A PLANT DEPARTMENT

PRODUCTION CONTROL DIVISION

Purchasing Section Inventory SectionPlanning & Scheduling Section

WAREHOUSE DIVISION

Raw Materials Finished Goods Returned Goods Dispensing Section

In-process section

ORGANIZATIONAL CHART OF A PLANT DEPARTMENT

Liquids

Medicated Application Powders, Aerosols

Quarantine Area

Approved for Use

Rejected Goods Area

Tablets, Capsules

PRODUCTION / MANUFACTURING DEPARTMENT

Extractives

Parenterals, Ophthalmic

WAREHOUSE DIVISION

Raw Materials

MANUFACTURING OF PHARMACEUTICALS

CLASSIFICATION OF PHARMACEUTICALS

LIQUIDS

EXTRACTIVES

MEDICATED APPLICATIONS

POWDERS & AEROSOLS

TABLES, CAPSULES AND PILLS

PARENTERALS AND OPHTHALMIC SOLUTIONS

SolutionsEmulsionsSuspensions

TincturesFluid ExtractsExtractResinsOleoresins

OintmentsCataplasm (Poultices)CementsCeratoseCreamsDressingsPastesPlastersSuppositories

OralDentifricesDoucheDusting PowdersInsufflations

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

• guarantees conformances to regulatory requirements

• guarantees product efficacy

• reduces operating cost and losses

• produces higher employee morale

• motivates pharmaceutical and medical professions to sell prescribe the product

- Errors may be due to 4 M’s

Machines

Men

Materials Method

s

- 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.

QUALITY CONTROL

-Contain a concise and precise statement of each ingredients used in the products with the correct weight and percentage.

- enumerate the characteristics of all materials to be used in the product & contain only the permissible range of purity of each ingredient.

QUALITY CONTROL

FORMULA RAW MATERIAL SPECIFICATION

- 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.

STANDARD OPERATING PROCEDURE

- 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

- cover all the characteristics that affects the performance of the product which includes purity, safety and stability.

FINISHED PRODUCT SPECIFICATION

- include all the packaging used for the product such as cans, tins, aluminum, caps, labels, cartoons, boxes, etc.

PACKAGING MATERIAL STANDARD

TESTING METHOD

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 Example

Materials a. Variation between supplies of same substance

b. Between batches from same supplier

c. Within a batch

Machines a. Variation of equipment for the same process

b. Differences adjustment of equipment

c. Aging and improper care

Methods a. Inexact procedures

b. Inadequate processes

c. Negligence by chance

Men a. Improper working conditions

b. Inadequate training and understanding

c. Dishonesty, fatigue and carelessness

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

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

(are placed in area of operation, warehouse, manufacturing and packaging sections)

Materials Inspection Section

QUALITY CONTROL

Analytical Laboratory

Materials Inspection Section

…to be continued next meeting

Prepare ½ crosswise for a short quiz

Good Luck!

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QUALITY CONTROL