Industrial Pharmacy The organizational Chart

 pharmaceutical research and Importance of chart:

manufacturing companies
 Can analyze organizational problems
 provide medicines in prefabricated or
 Can assess strength and weaknesses
ready-to-take form.
in functions and personnel.
 deals with the technology of various
 Can plan changes in the structure if
official and non-official products
not applicable.
Organization - a mechanism for determining
Drawbacks in Chart:
and assigning duties to people.
 Can not reveal company objectives
Business Organization - a combination of
and policies.
people, money and machines which fulfill an
 Can not indicate delegated authority.
economic objective.
 Reveals little about working
Elements of Organization relationships.
Division of Responsibility - work must be Basic Level of Top Mgt and their Functions:
identified and grouped logically.
LEVEL I Board of Trustees / Board of Directors
Delegation of Authority – defined and
delegated to avoid negligence of duty.  Protects and makes the most effective
use of the company’s assets.
Determination if interrelationship among
 Establishes objectives
functions - defined to promote harmonious  Represents and safeguards
teamwork. stockholders’ interests.
Basic Tools in an Organisation
LEVEL II President - Handles general
Organizational Chart management/administrative work
 Lists all important positions and LEVEL III - Vice President, General Managers,
functions of each division or Department Managers
department.
 Management of the major
 quickly showing the shape or
departments and specific divisions of
structure of the company.
the company.
Position Description - Clearly defines the
Basic forms of Organizational Structure
authority, duty or responsibility of the areas in
the chart. FUNCTIONAL STRUCTURE
Organizational Manual – “Management  Groups all activities on the basis of
Guide” similarity of functions.
 flexible, facilitates coordination and
 combines the chart and position
encourage specialization.
descriptions
 - company philosophy, objectives of DIVISIONALIZED STRUCTURE
the company policies, rules and
regulations of the company benefits Combines into one unit all different kinds of
and privileges of the personnel work

“Line” – constitutes the framework

“Staff” – constitutes the work functions CHEMICAL CONTROL SECTION

Three Stages of Research:  test and assay every lot of RM, in-
process products and FP.
Preliminary Stage – consists of chemical
 To conduct stability studies.
literature review, patent search and raw
material evaluation INSPECTION AND CHECKING SECTION
Applied Research Stage – chemical studies,  inspect and sample every
pharmacological studies, development of shipment
manufacturing process and cost of research.  To examine every shipment of
PMs.
Clinical Research Stage – manufacturing
 To examine and check all
requirements, research on label, review of
manufacturing operations
basic infos, product control, patent
 To sample retention or
application and cost of clinical trial.
reserved samples withdrawn
Specifications
BIOLOGICAL-MICROBIOLOGICAL CONTROL
Raw Materials Specifications – SECTION

 developed jointly by scientists 

 Also used in the procurement of drug To perform and evaluate
substances, excipients, reagents, microbiological and pharmaceutical
packaging and printed materials assays.
 To do sterility, pyrogenicity,
Containers Specifications - meaningful only if
bacteriological, irritation, and
they have been selected on the basis of tests
safety/toxicity tests.
performed on the product in the containers.
Biological tests are required for biological
Two Major Kinds of Impurities:
products, parenteral and eye preparations.
Product Specific Impurities - appear as by-
products or degraded product of the drug
Drug Manufacturer
Product Unspecific Impurities - introduced
externally into the product during processing. Any establishment engaged in operations
involved in the production of drugs, including
CENTRAL RELEASE SECTION
propagation, processing, compounding,
 examine meticulously the records finishing, filling, packing, repacking, altering,
resulting from the exercise of Quality or ornamenting with the end in view of
Control functions storage, distribution or sale of the product.
 examine meticulously the records
Types:
resulting from the exercise of Quality
Control functions  Ethical Drug Manufacturer
 maintain complete and accurate  Proprietary/Generic Manufacturers
records  Biologicals Manufacturer
 keep retention samples in locked  Veterinary Products Manufacturer
areas  Medicinal Chemicals Manufacturer
 properly record and handle finished  Toll or Contract Manufacturer
products
Drug Trader What is GMP?

 establishment which is a registered  part of Quality assurance

owner of the drug product, procures  set of principles and procedures
the materials and packaging  helps ensure that the
components and provides the products manufactured will have the
production monographs, quality required quality.
control standards and procedures, but
Quality - measured by its fitness for purpose .
subcontracts the manufacture of such
products to a licensed manufacturer. Safety and efficacy are not separable from
 engaged in the distribution and/or Quality but part of it
marketing of its products.
Factors Contributing to Quality Products
Drug Supplier
 Personnel
Includes manufacturers, importers and  Procedure
traders of drugs.  Equipment
 Premises
 Environment
MODULE 1A  Packing materials
Good Manufacturing Practice (GMP)  Raw materials
 Validation process
A Time line of GMP

 1902 - Development of the Biologic Good Manufacturing Practices

Control Act
 1906 - Development of the Pure Food  A basic tenet of GMP is that quality
and Drug Act cannot be tested into a batch of
 1938 - Federal Food, Drug and product but must be built into each
Cosmetic Act batch of product during all stages of
 1941 - Initiation of GMP the manufacturing process.
 designed to minimize the risks
 1944 - Development of Public Health
involved in any pharmaceutical
Services Act
production that cannot be eliminated
 1962 - Kefauver-Harris Drug
through testing the final product
Amendments released
 1963 - Establishment of GMPs for Risks if GMP is not followed
Drugs
 1975 - CGMPs for Blood and  unexpected contamination of
Components Final Rule products, causing damage to
 1976 - Medical Device Amendments health or even death.
 1978 - CGMPs for Drugs and Devices  incorrect labels on containers =
wrong medicine.
 1979 - GLPs Final Rule
 insufficient or too much active
 1980 - Infant Formula Act is passed
ingredient, resulting in ineffective
1972 and 1973 -Pacemaker failures reported treatment or adverse effects.
1975 - hearing-Dalkon Shield intrauterine
device caused thousands of injuries
 4. Validate work
Why GMP is important
5. Monitor facilities and equipment
 A poor quality medicine may contain
6. Write step by step operating procedures
toxic substances that have been
and work on instructions
unintentionally added.
 A medicine that contains little or none 7. Design ,develop and demonstrate job
of the claimed ingredient will not competence
have the intended therapeutic effect.
8. Protect against contamination
 GMP helps boost pharmaceutical
export opportunities 9. Control components and product related
 For importing of meds to other processes
countries
 Governments seeking to promote 10.Conduct planned and periodic audits
their countries export of
pharmaceuticals can do so by making List of important documents in GMP
GMP mandatory for all
pharmaceutical production and by  Policies
training their inspectors in GMP  SOP
requirements.  Specifications
 MFR (Master Formula Record)
GMP Covers…  Batch Manufacturing Record
 ALL aspects of production  Manuals
 Detailed, written procedures  Master plans/ files
 There must be systems to provide  Validation protocols
documented proof that correct  Forms and Formats
procedures are consistently followed  Records

QA - sum total of the organized arrangements

with the objective of ensuring that products 10 attributes of a good document
will be of the quality required for their 1. Accurate
intended use
2. Clear
GMP - part of Quality Assurance
3. Complete
QC - concerned with sampling, specification
4. Consistent
& testing, documentation & release
procedures which ensure that the necessary & 5. Indelible
relevant tests are performed & the product is
6. Legible
released for use only after ascertaining it’s
quality 7. Timely

8. Direct
Ten Principles of GMP
9. Authentic
1. Design and construct the facilities and
equipments properly 10. Authorized
2. Follow written procedures and Instructions

3. Document work
cGMP For Finished Pharmaceuticals

1. General Provision

2. Organization & Personnel

3. Building & Facilities

4. Equipment

5. Control of Components & Drug Product

Containers & Closures

6. Production & Process Control

7. Packaging & Labeling Control

8. Handling & Distribution

9. Laboratory Control

10. Records & Reports

11. Returned & Salvaged Drugs