Standard Operating Procedure for Storage of under test samples in Quality Control Laboratory
1.0 Purpose:
To lay down a procedure for Storage of under Test Samples in Quality Control Laboratory.
2.0 Scope:
The scope of this procedure is applicable for Storage of under Test Samples (Raw Materials, Semi – Finished, Finished, Process Validation, Stability and Packaging Material) in Quality Control Laboratory.
3.0 Responsibility:
QC Personnel: To Sample and Store the Under Test Samples.
Head QC/ Designee: To Monitor the Activity.
4.0 Definitions:
NA
5.0 Procedure:
• All Under Test Samples shall be kept in the respective cabinets under lock and key, and the keys shall be kept with the respective section head.
• Sterile/ Injectable Material Products shall be stored as per the product storage condition or as mentioned in the respective specification, in the cooling cabinet/ Deep freezer at ambient temperature.
• For cold chain products (2 – 8°C / – 20 °C), maintain the product / material list as per the respective format “Format for storage condition of cold chain product / raw material”.
• In case of cold chain products (i.e. 2 to 8 °C / – 20 °C) mentioned as per respective Format, carry the sample from the stability chamber to the Quality Control Laboratory in a container with a cool pack.
• Cabinets for storage of Under Test samples shall be separate for Active Raw Material, Excipient, and Liquid Samples.
• Semi-Finished and Finished Products shall also have separate Cabinets for Storage.
• Liquid Under Test samples shall be stored in a separate Storage Cabinet.
• Stability Study Samples shall be collected and stored separately as per the storage condition.
• Always handle the under-test samples carefully.
• Avoid spillage and contamination while handling the under-test samples.
• Wear Personal Protective Equipment (PPE) like Hand Gloves, Safety Goggles, Nose Mask (whichever applicable) while handling under test samples.
• Sample Storage Cabinets are placed in the Quality Control Laboratory.
• The Section In-charge/Designee shall receive and check the under-test samples against the Sampling Plan and Observation Sheet.
• He/She shall make necessary entries in the Inward Register and place the under-test samples in the respective Sample Storage Cabinet under Lock and Key.
• The Section In-charge/Designee shall allocate the under-test samples for Analysis.
• The Analyst shall take the under-test sample for analysis from the respective storage cabinet and keep the sample with him/her until the analysis is complete or until the end of the shift.
• If the analysis is pending or not completed, the under-test sample shall be kept in the respective storage cabinet.
• After completing Analysis, Analyst shall complete the report.
• The Reviewer shall review the report and calculation part as per “SOP for Review of Analytical Report”.
• After Analysis is complete and Batch is released, leftover samples shall be destroyed as per “SOP for Disposal of Leftover Samples and Scrap”.
• Raw Material, Finished Product, Stability, and Process Validation samples shall be stored as per their respective Formats.
• The Temperature of the Quality Control Laboratory should be about 23 ± 2 ºC except for Hot Room.
6.0 Acceptance Criteria:
Not Applicable.
7.0 Frequency:
For all the Under Test Samples received in Quality Control Laboratory.
8.0 Format for recording:
8.1 Format for “Raw Material, Finished Product, Stability and Process Validation sample storage cabinet”.
8.2 Format for “Storage condition of cold chain product / raw material”.