TOPIC 2 Standards and Quality Variation Flashcards
WEEK 2
are defined as documents that provide
requirements, specifications, guidelines, or characteristics
that can be used consistently to ensure that materials,
products, processes, and services are fit for their purpose
Quality standards
defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. ____ are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval
Specification
defined
as documents that provide
requirements, specifications,
guidelines, or characteristics that
can be used consistently to
ensure that materials, products,
processes, and services are fit for
their purpose. ___
Standards
(ASQ)
is a list of detailed
requirements (acceptance
criteria for the prescribed test
procedures) with which the
substance or pharmaceutical
product has to conform to
ensure suitable quality.
Specification
To avoid producing a defective
product, 1.__& 2. ___ are developed to
serve as basis for accepting or
rejecting a product.
Example of this is 3.___
Standards and Specifications
1-2. standards and
specifications
3. Drug Reference Standard
(RS)
is a standardized substance which is
used as a measurement base for similar
substances. Where the exact active
substances of a new drug are not known, a
reference standard provides a calibrated
level of biological effects against which new
preparations of the drug can be compared.
Drug Reference Standard
(RS)
This is concise and precise statement of the
ingredients that comprise the product, together with the
percentage and/or weight of each.
Formula
This should enumerate
the characteristics of all the materials that go into the
product and the permissible range of purity of each
ingredient. Standard compendia like the USP, NF, BP,
BPC, Merck Index, etc., provide this valuable
information.
Raw Material Specification
This is a
step by step method on how to go about a
job. It must spell out all information and
instructions that assure that variations in
production from day to day and week to
week will be held to within acceptable
established ranges.
Standard Operating Procedure.
This should
be set for everything that goes around the
product, i.e., bottles, cans, aluminum foil,
cellophane, jars, caps, cap liners, labels,
printed inserts, cartons, wrapping papers,
and shipping cases.
Packaging Material Standard
This
should cover all characteristics that affect
the proper performance, purity, safety and
stability of the product.
Finished Product Specification
These are indispensable
in assuring conformity to standards. Since
they play such a vital role, testing
procedures must be standardized so that
they yield results of comparable precision
and accuracy in the hands of different
operators and laboratories. The tests must
be validated to ensure precision and
accuracy on application.
Testing Methods
What are the Official References: (primary)
v United States Pharmacopoeia and National Formulary
v Japan Pharmacopeia
v British Pharmacopeia
v European Pharmacopeia
v International Pharmacopeia
is a legally
binding collection, prepared by a
national or regional authority of
standards and quality
specifications for medicines used
in that country or region
Pharmacopoeia
a is used to furnish quality
specifications for active pharmaceutical
ingredients (APIs), FPPs and general
requirements.
Pharmacopoeia
presents the basic assumptions,
definitions, and default conditions for the
interpretation and application of the USPNF
General Notices Section
Requirements stated apply to all
articles recognized in the USP and NF
and to all general chapters unless
specifically stated otherwise.
General Notices Section
General Chapters 1 to 999
Example is 1.__
Physical tests and determinations,
microbiological tests, Chemical tests and
assays, Biological tests and assays
- ENFORCEABLE
General Chapters 1000 to 1999
General Information (no
mandatory requirement)
General Chapter Above 2000
apply to articles classified as
Dietary ingredient or supplements
<1>
Injections
<2>
Oral Drug Products—Product Quality Tests
<231>
Heavy Metals
<621>
Chromatography
<671>
Containers
<761>
Nuclear Magnetic Resonance
<851>
Spectrophotometry
<781>
Optical Rotation
<1160>
Pharmaceutical Calculations in
Prescription Compounding
<1176>
Prescription Balances and Volumetric
Apparatus Used in Compounding:
<2232>
Elemental Contaminants in Dietary
Supplements
<2750>
Manufacturing Practices for Dietary
Supplements
is a combination of two official compendia:
The USP–NF
1-2. United States Pharmacopeia (USP) and the National
Formulary (NF).
Monographs for drug substances and preparations are
featured in the 1.__
- USP
Monographs for 1-2. __
appear in a separate section of the USP.
- dietary supplements and ingredients
Excipient monographs are found in the 1.___
NF.
Year of creation to signing of the first Philippine
Pharmacopeia in cooperation with the Japanese
Government through the initiatives of 2-3.___
- 1996
2-3. Dr. Conrado S.
Dayrit and Prof Akira Hamada.
- When was the creation of Pharmacopeia Organization
for the preparation and publication of the Phil
Pharmacopeia thru 2 - Declaring and adopting the Phil Pharmacopeia as the Official book of Standards
nd Reference for Pharmaceutical Products and Crude plant drugs in the Philippines
- May 26, 1999
- Department Order no. 216-F
- Exec. Order 302 (2004)
approved Standard Setting Organization
or its foreign equivalent
- ANSI
Standards Setting Organization (SSO)
a government sponsored organization
(where sponsorship is not based solely on financial
contributions by the government), a multimember consortia or industry recognized
organization Standards Setting Organization (SSO)
Standards Setting Organization (SSO)
(Guidelines: Norms and Standards for Pharmaceuticals)
WHO
Current Good Manufacturing Practice (CGMP) Regulations
FDA
Adoption and Implementation of the
Pharmaceutical Inspection and Scheme )PIC/S) Guides for the
Good manufacturing practice for medicinal products
AO 2012 – 0008
Guidelines for The Classification of
Deficiencies Observed During Inspection of Drug Manufacturers
Circular No.2019-003
is the
leading the international development, implementation and
maintenance of harmonized GMP standards and quality systems of
Inspectorates in the field of medicinal products
PIC/S - Pharmaceutical Inspection Cooperation Scheme Guides
◎ICH - International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use:
Establish a uniform set of standards for drug
registration
non-profit Association under Swiss law on
2.___
- International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use - October 23, 2015
Brings the regulatory authorities and pharmaceutical
industry to discuss about scientific and technical aspects
about drug registration.
International Council for Harmonisation
Reduction of unnecessary animal testing without
compromising safety and effectiveness accomplished
through 1.__ that are implemented by the
regulatory authorities.
Technical Guidelines
Main goal of International Council for Harmonisation is to
achieve greater harmonization worldwide.