This document presents on stability testing as per ICH guidelines. It discusses the objectives, scope and principles of stability testing as defined in ICH Q1A(R2). Key aspects covered include types of stability testing such as long term, accelerated and stress testing. It also touches upon important terminologies like primary batches, commitment batches, pilot batches and production batches. The document further elaborates on the steps involved in stability testing of drug substances and drug products as well as evaluation parameters for different product types. Bracketing and matrixing approaches for reduced stability study designs are also summarized as per ICH Q1D guidelines.
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredient (APIs) & finished pharmaceutical protocols (FPPs), replacing the previous WHO guidelines in this area. However, alternative approaches can be used when they are scientifically justified. Further guidelines can be found in International Conference on Harmonisation (ICH) guidelines and in the who guidelines on the active pharmaceutical ingredient master file procedure.
The presentation will give an insight into ICH Q1A Stability testing of New drug products. Here the ppt is much focused on stability requirements for ANDA, no: of batches, storage conditions, testing frequency.
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredient (APIs) & finished pharmaceutical protocols (FPPs), replacing the previous WHO guidelines in this area. However, alternative approaches can be used when they are scientifically justified. Further guidelines can be found in International Conference on Harmonisation (ICH) guidelines and in the who guidelines on the active pharmaceutical ingredient master file procedure.
The presentation will give an insight into ICH Q1A Stability testing of New drug products. Here the ppt is much focused on stability requirements for ANDA, no: of batches, storage conditions, testing frequency.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
Stability Testing During Product DevelopmentAl Riyad Hasan
Stability Testing During Product Development:
Practical conduct of stability testing
Presentation and recording of results
Stability data handling and estimation of shelf life
Package Labelling
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
Stability Testing During Product DevelopmentAl Riyad Hasan
Stability Testing During Product Development:
Practical conduct of stability testing
Presentation and recording of results
Stability data handling and estimation of shelf life
Package Labelling
ICH STABILITY TESTING GUIDELINES (ICH Q1A-Q1F).pptxDurgadevi Ganesan
ICH Stability Testing Guidelines: ICH Q1A-Q1F (Q1 series)
Q1A(R2): STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1B: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1C: STABILITY TESTING FOR NEW DOSAGE FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E: EVALUATION OF STABILITY DATA
Q1F: STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III & IV
Shivam Dubey Pharmaceutics Assignment 03: ICH Guidelines On Drug StudiesMrHotmaster1
Sedatives & Hypnotics
Sedatives
➢ It is a drug that reduces excitement and calms the person
➢ A drug that reduces excitement, calms the patient (without inducing sleep)
➢ Sedatives in therapeutic doses are anxiolytic agents
➢ Most sedatives in larger doses produce hypnosis (trans like state in which
subject becomes passive and highly suggestible)
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
Quality Safety Efficacy Multidisciplinary (Q S E M)
ICH Q1 Stability
Case toxicity of ethylene glycol and diethylene glycol in cough syrup.
accelerated stability studies
constant interval method
29. • Selection of Batches:
Drug Substance Drug Product
Number of
Batches
at least three primary batches
of the DS
at least three primary batches of
the DP
Scale minimum of pilot scale two of the three batches should
be at least pilot scale, third batch
may be smaller
Process same synthetic route that
simulates the final process for
production
simulate that to be applied to
production batches
Container
Closure
the same as or simulates the
packaging proposed for storage
and distribution
in the packaging proposed for
marketing
33. • Storage Conditions – General Case:
* testing at the Intermediate Storage Condition is conducted if there is
“significant change” (as defined in Q1A) at the Accelerated Storage Condition
Study Storage condition Minimum time period
covered by data at
submission
Long term 25°C ± 2°C/60% RH ± 5% RH
or
30°C ± 2°C/65% RH ± 5% RH
12 months
Intermediate* 30°C ± 2°C/65% RH ± 5% RH 6 months
Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months
34. • Storage Conditions - Semi-permeable containers:
– aqueous-based products packaged in semi-permeable
containers should be evaluated for potential water loss
Study Storage condition Minimum time period
covered by data at
submission
Long term 25°C ± 2°C/40% RH ± 5% RH
Or 30°C ± 2°C/35% RH ± 5% RH
12 months
Intermediate 30°C ± 2°C/65% RH ± 5% RH 6 months
Accelerated 40°C ± 2°C/Not More Than (NMT)
25% RH ± 5% RH
6 months
35. • Storage Conditions (continued):
– refrigerator:
– freezer:
– below -20°C:
• treated on a “case-by-case basis”
Study Storage Condition
Minimum Time Period
at Submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C / 60% RH ± 5% RH 6 months
Study Storage Condition
Minimum Time Period
at Submission
Long term -20°C ± 5°C 12 months
48. Q1D – Bracketing
• BRACKETING - Container Closure Sizes and Fills:
Strength 50 mg
Batch B1 B2 B3
15 mL T T T
100 mL
Container Size
500 mL T T T
Key: B1 – B3 indicate batches, T = sample tested
51. Q1D - Bracketing and Matrixing
• MATRIXING - Simple design on time points:
– A practical, “one-half reduction”:
Time point (months) 0 3 6 9 12 18 24 36
Batch 1 T T T T T T
Batch 2 T T T T T T
Strength 1
Batch 3 T T T T T
Batch 1 T T T T T
Batch 2 T T T T T T
Strength 2
Batch 3 T T T T T
T = sample tested
54. ICH
REFERENCES:
• Q1A(R2): Stability Testing of New Drug Substances and
Products
• Q1B: Stability Testing: Photostability Testing of New Drug
Substances and Products
• Q1D: Bracketing and Matrixing Designs for Stability Testing of
Drug Substances and Drug Products
• Q1E: Evaluation for Stability Data