Critical Quality Attributes.
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ScribdTranslationsCritical Quality Attributes.
Uploaded by
ScribdTranslationsCritical attributes
of quality
solid pharmaceutical forms
Capsules and tablets
Integrantes de equipo:
Ávila Juárez María Guadalupe
Contreras Reyes Luis Ángel
Medina Becerril Sergio Enrique
Moreno Marín Paulina
INTRODUCTION
The critical quality attributes (CQA) are those properties or
physical, chemical, biological or microbiological characteristics of a material
for export, including the finished pharmaceutical product that must be
within a limit, range, or appropriate distribution to ensure the
desired quality of the product. (Zhang, L., & Mao, S., 2017)
.
CQA in solid F.f.
oral
Identity Purity Biological activity stability
They are usually aspects that affect the purity, potency, release of the
drug and product stability
01
CAPSULES
Purity
MGA 0089 MGA 0500
Purity
MGA 0241
MGA 0351
MGA 0231
Biological activity
The invivo-in vitro correlation of immediate release dosage forms has a limited usefulness for making a
extrapolation
● Level C: Relate a sampling point of the dissolution with a pharmacokinetic parameter.
Single point correlation.
● Level B: Statistical moment analysis. The average time of the dissolution in vitro is compared
with the average time of dissolution in vivo.
Biological activity
Dissolution testing apparatus:
● Device 1 - Basket.
● Device 2 - Palette.
● Apparatus 3 - Oscillating Cylinder.
● Apparatus 4 - Continuous Flow Cell.
● Device 5 - Palette on Disk.
● Device 6 - Cylinder.
● Device 7 - Vertical Oscillation Support.
CAPSULES
Quality objectives
Quality attributes Criticality
Product profile Quality objective
objective quantitative
Dosage form Capsules (rigid or Effectiveness in absorption
blend) of the p.a.
Smell Acceptable Allows the acceptance
by the patient.
pH 5-9 Ensures absorption
of the p.a.
Requirements Disintegration Allows compliance
technicians according to the form Dissolution of specifications.
pharmaceutical Humidity 13-16%
Essay on Identity Positive/meet them Guarantees the effectiveness of
(initial and final) requirements 90-110% the activity
pharmacological.
02
TABLETS
TABLETS
Critical Quality Attribute (CQA) Justification
Essay The variability of the trial will affect safety and efficacy. The variables
of the process can affect the analysis of the pharmaceutical product. therefore
therefore, the essay will be evaluated throughout the development of the product and of
process.
Content uniformity The variability in the uniformity of the content will affect safety and the
effectiveness, both the formulation and the process variables will affect the
uniformity of the content, so it will be evaluated throughout the product and the
process.
Dissolution The failure to comply with the dissolution specification can affect the
bioavailability, both the formulation and the process variables
they affect the dissolution profile. It will be evaluated throughout the formulation and the
development of the process.
TABLETS
Critical Quality Attribute (CQA) Justification
Valuation To ensure that the formed tablets present the principle
active in appropriate percentages to meet the window
therapeutic.
Muc adhesion time The failure of the critical parameter to show adhesion to the stomach
results in a variation of bioavailability.
Hardness It can affect the disintegration that may be indirectly
related to drug release.
Identification This CQA can be effectively controlled by the system.
of quality management and is monitored at the time of release
of the pharmaceutical product.
Quality attributes for chewable tablets
Rocha Saleme, H., Cuadro Julio, J. E., Mora Huertas, C. (2013). Application of Quality by Design (QbD)
in the reformulation of chewable tablets. Colomb. Rev. Chem. Pharm. Vol. 42 (2), 190-214.
Department responsible for identifying critical quality attributes
QUALITY RISK MANAGEMENT SYSTEM
Quality Control is the entity responsible for carrying out all
the analyses to determine if the medication
meets the legal requirements declared by each
company and what the products must comply with
pharmaceuticals.
REFERENCES
Rocha Saleme, H., Cuadro Julio, J. E., Mora Huertas, C. (2013). Application of quality by design (QbD) in reformulation
of chewable tablets. Colomb. Rev. Sci. Chem. Pharm., Vol. 42 (2), 190-214.
Zhang, L., & Mao, S. (2017). Application of quality by design in the current drug development. Asian Journal of Pharmaceutical Sciences,
12(1), 1–8. doi:10.1016/j.ajps.2016.07.006
US Food and Drug Administration. Nov 2009. Guidance for Industry, Q8(R2) Pharmaceutical development. Rockville, MD.
US Food and Drug Administration. Nov 2009. Guidance for Industry, Q11 Development and manufacture of drug substances (chemical
entities and biotechnological/biological entities). Rockville, MD.
THANKS!
