Standard Operating Procedure for Quality Control Testing in Cream Manufacturing
1) Purpose
The purpose of this SOP is to outline the steps required for quality control (QC) testing of creams in a pharmaceutical manufacturing setting to ensure they meet the required standards for safety, efficacy, and quality.
2) Scope
This SOP applies to all QC personnel involved in the testing of creams within the pharmaceutical production facility. It covers various tests, including physical, chemical, and microbiological assessments.
3) Responsibilities
It is the responsibility of the QC team to perform all required tests accurately and within the specified timelines. The QC manager is responsible for ensuring compliance with this SOP and for reviewing and approving all QC test results.
4) Procedure
4.1 Sample Collection
4.1.1 Collect samples of the cream from different points in the batch according to the sampling plan.
4.1.2 Ensure that samples are representative of the entire batch and are collected using sterile equipment.
4.1.3 Label the samples appropriately with batch number, date, and sampling point.
4.2 Physical Tests
4.2.1 Appearance: Visually inspect the cream for color, texture, and homogeneity.
4.2.2 Viscosity: Measure the viscosity using a viscometer according to the specified method.
4.2.3 pH: Measure the pH of the cream using a calibrated pH meter.
4.2.4 Particle Size: Analyze the particle size distribution using appropriate techniques such as laser diffraction.
4.3 Chemical Tests
4.3.1 Assay of Active Ingredient: Quantify the active pharmaceutical ingredient (API) using validated analytical methods such as HPLC.
4.3.2 Preservative Content: Measure the concentration of preservatives using appropriate analytical techniques.
4.3.3 pH Adjusters: Verify the levels of pH adjusters if applicable.
4.4 Microbiological Tests
4.4.1 Total Viable Count (TVC): Determine the total bacterial count using plate count methods.
4.4.2 Pathogen Testing: Test for specific pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans.
4.4.3 Preservative Efficacy Test (PET): Assess the effectiveness of the preservative system over time.
4.5 Stability Testing
4.5.1 Conduct stability testing under various conditions (e.g., temperature, humidity) to determine the shelf life of the cream.
4.5.2 Analyze samples at specified intervals for physical, chemical, and microbiological stability.
4.6 Documentation and Reporting
4.6.1 Record all test results in the appropriate logbooks and batch records.
4.6.2 Compare results against the specifications outlined in the product dossier.
4.6.3 Generate a QC report summarizing the findings and any deviations from the specifications.
4.7 Review and Release
4.7.1 Submit the QC report to the Quality Assurance (QA) department for review.
4.7.2 The QA department will review the results and decide on the release or rejection of the batch.
4.7.3 Document the final decision in the batch record and update the inventory accordingly.
5) Abbreviations, if any
QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
GMP: Good Manufacturing Practices
TVC: Total Viable Count
PET: Preservative Efficacy Test
6) Documents, if any
Batch Manufacturing Record (BMR)
Quality Control Test Methods
Quality Control Logbooks
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Non-Sterile Semisolid Dosage Forms
8) SOP Version
Version 1.0
