Pharmaceutical Industry
• Types
– Active
pharmaceutical ingredients
– Generics
– Biologics
Quality Management System (QMS)
Good Manufacturing Practices (GMP)
Performance
standards that WHO and many national governments established for pharmaceutical
manufacturers covering, for e.g. personnel, facilities, packaging, and quality
control.
GMPs are
part of the quality assurance activities that ensure that products are
consistently produced and controlled to the quality standards appropriate to
their intended use and required by the drug regulatory authorities.Good Laboratory Practices (GLP)
A set of
principles that provides a framework within which laboratory studies are
planned, performed, monitored, recorded, reported and archived.
These
studies are undertaken to generate data by which the hazards and risks to
users, consumers and third parties, including the environment, can be assessed
for pharmaceuticals, agrochemicals, cosmetics, food additives, feed additives
and contaminants, novel foods, biocides, detergents etc....
GLP helps
assure regulatory authorities that the data submitted are a true reflection of
the results obtained during the study and can therefore be relied upon when
making risk/safety assessmentsod Laboratory Practices (GLP).
Main goal is
to obtain results that are:
– Reliable
– Repeatable
–
Reproducible
– Auditable
– Recognized
by scientists worldwide
Five basic points :
– Resources:
management, personnel, building and equipment
–
Characterization: test article, test system
– Rules:
protocols, study plans, procedures
– Results:
raw data, final report, archives
– Quality
Assurance: audit/inspection, training, advice
Resources:
•
Management: Good Science, Good organization
• Personnel:
Reporting relationships, CV, Training, job description.
• Facilities
(building and equipments):
– Buildings:
size, suitability, construction, maintenance, minimum disturbances, separation
between activities.
–
Equipments: suitability, calibration, documentation.
Characterization:
• Test
Items: product, active ingredient, an additive, extract, chemical compound,
etc.
• Test
System: animal, plant, bacterium, isolated organ, field, equipment, etc.
Rules:
• Defining
who does what, how, when and where.
• Protocols
/ Study Plan: overall plan of experiments
• Standard
Operating Procedures: detailed instructions for all routine processes
• Protocols / Study Plan:
– Approved
by study director
– May follow
scientific guidelines
–
Information on major events of the study
– Provides
overall time frame.
– MASTER
PLAN
• Standard
Operating Procedures:
– Written
detailed instructions: centralized organization, readable, clear, precise,
practical.
– Cover all
laboratory activities: administrative, safety, hygiene, technical, etc.
– Provide
in-depth instructions:
Results:
•
Descriptive documents, give us the results of the experiment.
• Raw Data:
numerical values, handwritten observations, calculations, etc.
• Final
Report: A complete document.
• Raw data
collection on prescribed forms/note books so that they indicate:
– WHAT was
done
– HOW it was
done
– WHEN it
was done
– WHO
collected the data.
• Final
Report:
– Name and
address of the test facility/lab
– Date and
duration of study
– Study
objectives
– Test
article details
– Test
system details
– Results
– References
– Signed/dated
reports from scientists
• Archives:
– Long term,
secure storage, and fast retrieval of data.
– All
original scientific data, master documents, reports, etc.
– Endpoint
for regulated work.
– Quality
Assurance:
• Ensures
management that all the quality processes implemented are functioning
correctly.
• Act as an
independent QA service.
• May also
serve as facilitator and consultant.
• Review the
whole system, i.e. study plan, SOPs, etc
• Assure
study plan and SOPs are available.
• Ensure inspection
and audit.
• QA
inspection/audit
– Study
based: protocol/study plan, data, reports
–
Facility/system based: building, equipment, support services, computer system,
personnel training/ documentation.
– Process
based: inspection of processes which occur frequently, for e.g. slide
preparation, filtration method, microbial limit test, etc.
Pharmaceutical
Quality Assurance (QA)—Sum of all activities and responsibilities required to ensure that the medicine
that reaches the patient is safe, effective, and acceptable to the patient.
Pharmaceutical
Quality Control (QC)—Process
concerned with medicine sampling, specifications, testing, and with the
organizations release procedures that ensure that the necessary tests are
carried out and that the materials are not released for use, nor products
released for sale or supply, until their quality has been judged satisfactory.
Determinants of Medicine Quality
Identity: Active ingredient
Purity: Not contaminated with potentially
harmful substances
Potency: Usually 90–110% of the labeled amount
Uniformity: Consistency of color, shape, size
Bioavailability: Administered vs. Availability
Stability: Ensuring medicine activity for
stated period
How Is Quality Assessed
INSPECTION
of products on arrival
Visual inspection
Product specification review (including
expiration dates)
LABORATORY TESTING for compliance with
pharmacopoeial standards
International Pharmacopoeia
European Pharmacopoeia
U. S. Pharmacopeia
British Pharmacopoeia
National Pharmacopoeia
BIOAVAILABILITY DATA
How Is Medicine Quality Assured
Product
selection
Long shelf-life
Acceptable stability
Acceptable bioavailability
Selection of appropriate suppliers
Supplier pre-qualification
Request samples from new suppliers
Request specific reports and data for certain
medicines (e.g., bioavailability and stability studies)
Collect and maintain information on supplier
performance.
How Is Medicine Quality Assured
Product
certification
GMP certificate of manufacturer
Product/batch certification (COA)
Random local testing
Contract and procurement specifications
Pharmacopeia reference standard
Local language for product label
Standards for packaging to meet specific
storage and transport conditions.
How
Is Medicine Quality Assured
Appropriate
storage, transport, dispensing, and use
procedures
Pharmaceutical distribution and inventory
control procedures
Provision for appropriate storage and
transport including adequate temperature control, security, and cleanliness
Explicit enforcement of cold chain procedures
Appropriate dispensing: containers, labeling,
counseling
Avoidance of repacking unless quality control
in place.
Product monitoring system
Problem reporting: who, how, where, and to
whom; what additional measures; what follow-up information
Product recalls: hospital or country level.
Who Ensures Medicine Quality
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