Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Preservation of Control Samples of Active Ingredients. This SOP ensures that control samples of active ingredients (API) are preserved and stored in a manner that maintains their integrity, ensuring reliable quality control and regulatory compliance.

1. Purpose

To establish a standardized procedure for the proper preservation, storage, and handling of control samples of active pharmaceutical ingredients (APIs) to maintain their quality and integrity for use in regulatory compliance, quality control, and future reference.

2. Scope

This SOP applies to the handling, preservation, and storage of control samples of APIs at [Company/Facility Name]. It covers the procedures for selecting appropriate samples, labeling, and ensuring their preservation in compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.

3. Responsibilities

• Quality Control (QC) Personnel: Responsible for the collection, labeling, and storage of control samples. Ensures compliance with this SOP during preservation.

• QC Supervisor: Responsible for overseeing the control sample preservation process and ensuring records are maintained.

• Warehouse/Storage Personnel: Ensures proper storage conditions are maintained for the control samples.

• Regulatory Affairs: Ensures compliance with regulatory requirements regarding the storage and retention of control samples.

4. Materials and Equipment

• Control Sample Containers (e.g., glass vials, amber bottles)

• Appropriate labeling materials (e.g., labels, barcode scanners)

• Desiccators or refrigerators (depending on storage requirements)

• Temperature and humidity monitoring equipment (if required)

• Freezer (if required for temperature-sensitive samples)

• Record forms for documentation (e.g., control sample log, storage conditions log)

5. Procedure

5.1 Collection of Control Samples

1. Sample Selection:

   • Select representative control samples from the production batch of the API in accordance with GMP and regulatory guidelines.

   • Control samples should be collected at the time of production or after final approval of the API batch.

2. Quantity of Sample:

   • Typically, a control sample of 1-2% of the batch size is collected. The exact quantity should be determined based on regulatory requirements or company policy.

   • The sample must be large enough to perform multiple tests over its retention period.

3. Sample Handling:

   • Ensure that the samples are collected using clean and dry equipment to avoid contamination.

   • Handle the sample with care to avoid degradation or contamination. Avoid unnecessary exposure to air, light, or moisture.

5.2 Labeling of Control Samples

1. Labeling Information:

   • Label each control sample container with the following information:

     • Product name (API)

     • Batch number

     • Date of manufacture

     • Expiry date (if applicable)

     • Date of sample collection

     • Sample identifier (e.g., “Control Sample”)

     • Quantity of sample collected

     • Name of the person collecting the sample

2. Additional Information:

   • If necessary, barcode or number each sample for easier tracking and retrieval.

   • Ensure all labels are legible and tamper-evident (if required).

5.3 Storage of Control Samples

1. Storage Conditions:

   • Store the control samples in a clean, dry environment, free from contaminants.

   • Ensure that the storage area is temperature and humidity-controlled (e.g., 25°C ± 2°C, 60% relative humidity, unless otherwise specified for specific APIs).

   • If the API is sensitive to light, store the samples in amber containers or opaque packaging to protect them from photodegradation.

   • If the sample is temperature-sensitive, store in a refrigerator or freezer as per the specific API requirements.

2. Use of Desiccators or Humidity-Controlled Storage:

   • If the sample is hygroscopic or sensitive to moisture, store in desiccators or other humidity-controlled environments.

   • Ensure that any desiccators or humidity control equipment are regularly monitored and maintained.

3. Separation and Organization:

   • Store control samples separately from other materials to avoid confusion. Use labeled shelves or storage bins to organize control samples based on product and batch number.

   • Ensure control samples are easily accessible for future analysis or inspection.

5.4 Monitoring and Recordkeeping

1. Temperature and Humidity Monitoring:

   • Monitor and document the storage conditions (e.g., temperature and humidity) regularly using calibrated instruments.

   • Maintain a log of temperature and humidity readings for audit and compliance purposes.

2. Control Sample Log:

   • Maintain a log of control samples that includes details such as:

     • Sample identifier

     • Batch number

     • Date of sample collection

     • Storage location

     • Condition of storage

     • Temperature/humidity logs (if applicable)

     • Name of the personnel responsible for storing the sample

3. Storage Period:

   • Control samples should be stored for a minimum of [Enter number of years] years or the duration specified by regulatory requirements or internal policies.

   • After the retention period, control samples should be disposed of following the company’s waste disposal procedures, ensuring that the disposal process is compliant with environmental and safety regulations.

5.5 Retrieval and Testing of Control Samples

1. Sample Retrieval:

   • Retrieve control samples from storage only when needed for testing, stability studies, or regulatory inspections.

   • Record the date and reason for sample retrieval in the control sample log.

2. Testing:

   • Perform any necessary testing or analysis on the control sample in accordance with the required testing methods (e.g., stability testing, quality control analysis).

3. Re-storage of Remaining Sample:

   • If a portion of the control sample remains after testing, ensure that the remaining sample is returned to its proper storage conditions and re-record its location and status in the control sample log.

5.6 Disposal of Control Samples

1. Disposal:

   • When control samples are no longer required or have exceeded their retention period, dispose of them in accordance with regulatory requirements and company policies.

   • Disposal should be carried out in a way that ensures the API cannot be retrieved or misused.

2. Record of Disposal:

   • Document the disposal of control samples, including the batch number, sample identifier, and reason for disposal, along with the date of disposal.

6. Precautions

• Ensure that control samples are not exposed to conditions that may compromise their integrity, such as high temperatures, humidity, or light.

• Handle all samples with care to prevent contamination or degradation.

• Follow the specific storage requirements for each API as detailed in the product’s data sheet, if available.

• Ensure that control sample containers are sealed tightly to prevent leakage or contamination.

7. Documentation and Records

• Control Sample Log: A log documenting all control sample details, including collection, storage, testing, and disposal information.

• Temperature and Humidity Logs: A record of the temperature and humidity readings in the storage area.

• Disposal Log: A record of the disposal of control samples when their retention period has expired.

8. Reference Documents

• Regulatory guidelines for sample retention (e.g., FDA, EMA, ICH guidelines)

• USP and other pharmacopeial guidelines on sample preservation

• Manufacturer’s storage and handling instructions for active pharmaceutical ingredients.

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