Standard Operating Procedure for Stability Testing in Cream Manufacturing
1) Purpose
The purpose of this SOP is to outline the steps required for stability testing of creams in a pharmaceutical manufacturing setting to ensure they maintain their intended physical, chemical, and microbiological properties over their shelf life.
2) Scope
This SOP applies to all personnel involved in the stability testing of creams within the pharmaceutical production facility. It covers the procedures for sample storage, testing, and analysis under various conditions.
3) Responsibilities
It is the responsibility of the stability testing team to follow this SOP accurately and ensure that all stability studies comply with GMP and ICH guidelines. The stability coordinator is responsible for overseeing the stability testing process and ensuring proper documentation.
4) Procedure
4.1 Preparation for Stability Testing
4.1.1 Identify the batches of creams to be subjected to stability testing and assign unique stability study numbers.
4.1.2 Prepare samples from each batch according to the sampling plan, ensuring representative and homogenous samples.
4.1.3 Label each sample with the batch number, stability study number, and intended storage conditions.
4.2 Storage Conditions
4.2.1 Store the samples under various conditions as per ICH guidelines, including:
4.2.1.1 Long-term storage: 25°C ± 2°C / 60% RH ± 5% RH
4.2.1.2 Intermediate storage: 30°C
4.2.1.3 Accelerated storage: 40°C ± 2°C / 75% RH ± 5% RH
4.2.2 Record the storage conditions and ensure the stability chambers are continuously monitored and maintained.
4.3 Testing Schedule
4.3.1 Conduct stability testing at specified intervals, such as initial (T0), 3 months, 6 months, 9 months, 12 months, and annually thereafter for long-term studies.
4.3.2 For accelerated and intermediate studies, follow the specific timelines outlined in the study protocol.
4.4 Physical Tests
4.4.1 Appearance: Visually inspect the cream for any changes in color, texture, and homogeneity.
4.4.2 Viscosity: Measure the viscosity using a viscometer according to the specified method.
4.4.3 pH: Measure the pH of the cream using a calibrated pH meter.
4.4.4 Particle Size: Analyze the particle size distribution using appropriate techniques such as laser diffraction.
4.5 Chemical Tests
4.5.1 Assay of Active Ingredient: Quantify the active pharmaceutical ingredient (API) using validated analytical methods such as HPLC.
4.5.2 Degradation Products: Identify and quantify any degradation products using suitable analytical techniques.
4.5.3 Preservative Content: Measure the concentration of preservatives using appropriate analytical techniques.
4.6 Microbiological Tests
4.6.1 Total Viable Count (TVC): Determine the total bacterial count using plate count methods.
4.6.2 Pathogen Testing: Test for specific pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans.
4.6.3 Preservative Efficacy Test (PET): Assess the effectiveness of the preservative system over time.
4.7 Data Analysis and Reporting
4.7.1 Record all test results in the stability study logbook and electronic database.
4.7.2 Compare the results against the initial data and specified acceptance criteria.
4.7.3 Generate a stability study report summarizing the findings and any trends observed.
4.7.4 Submit the report to the Quality Assurance (QA) department for review and approval.
4.8 Conclusion and Actions
4.8.1 Based on the stability data, determine the shelf life and storage conditions for the product.
4.8.2 Document any required changes to the product’s labeling or storage conditions.
4.8.3 Implement any corrective actions if stability issues are identified.
5) Abbreviations, if any
GMP: Good Manufacturing Practices
ICH: International Council for Harmonisation
RH: Relative Humidity
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
TVC: Total Viable Count
PET: Preservative Efficacy Test
6) Documents, if any
Stability Study Protocol
Stability Study Logbook
Batch Manufacturing Record (BMR)
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
8) SOP Version
Version 1.0
