Standard Operating Procedure for Sample Collection for Quality Testing in Creams
1) Purpose
The purpose of this SOP is to outline the procedures for collecting samples of creams for quality testing to ensure that samples are representative, properly handled, and suitable for accurate analysis.
2) Scope
This SOP applies to all personnel involved in the collection of samples for quality testing in creams production, including production operators, quality control (QC) technicians, and quality assurance (QA) personnel. It covers procedures for sample collection, handling, labeling, and storage.
3) Responsibilities
It is the responsibility of production operators to collect samples, QC technicians to perform quality testing, and QA personnel to oversee the sampling process and ensure compliance with this SOP.
4) Procedure
4.1 Preparation for Sample Collection
4.1.1 Review the sampling plan and identify the points in the production process where samples need to be collected.
4.1.2 Ensure all sampling equipment and containers are clean, dry, and suitable for the type of sample being collected.
4.1.3 Label sample containers with necessary information, including sample ID, batch number, date, and time of collection.
4.1.4 Wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and hairnet to avoid contamination.
4.2 Collection of Samples
4.2.1 Follow the specific sampling
4.2.2 Use clean sampling tools (e.g., spatulas, scoops) to collect the sample, ensuring minimal exposure to air and contaminants.
4.2.3 Collect samples from multiple locations within the batch to ensure representativeness (e.g., top, middle, bottom of the mixing vessel).
4.2.4 Immediately transfer the collected sample into the labeled container and seal it tightly.
4.2.5 Record details of the sampling process in the sampling log, including the sample ID, batch number, date, time, and any observations.
4.3 Handling and Transport of Samples
4.3.1 Handle samples with care to avoid contamination, degradation, or loss during transport to the QC laboratory.
4.3.2 If samples need to be transported, use appropriate packaging to protect them from physical damage and environmental conditions (e.g., temperature, humidity).
4.3.3 Ensure samples are transported to the QC laboratory as soon as possible after collection to maintain their integrity.
4.4 Storage of Samples
4.4.1 Store samples under conditions specified in the sampling plan (e.g., refrigerated, room temperature) until testing is performed.
4.4.2 Label storage areas with appropriate information to ensure proper identification and retrieval of samples.
4.4.3 Monitor storage conditions regularly to ensure compliance with specified requirements.
4.5 Documentation
4.5.1 Ensure all details of the sample collection process are accurately recorded in the sampling log and any associated forms.
4.5.2 Maintain records of sample collection, handling, and storage according to company policy and regulatory requirements.
4.5.3 Ensure that documentation is complete, accurate, and readily accessible for review by QA personnel or regulatory inspectors.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
6) Documents, if any
Sampling Plan
Sampling Log
Sample Collection Forms
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP (United States Pharmacopeia) General Chapter on Sampling
8) SOP Version
Version 1.0