SOP for handling of Handling of Reference Standards, Impurity standards and System suitability solutions in pharmaceutical.
1.0 Purpose:
To lay down the procedure for handling of Handling of Reference Standards, Impurity standards and System suitability suitability.
2.0 Scope:
This procedure is applicable for handling of Reference Standards, Impurity standards and System suitability solutions in Quality Control Laboratory.
3.0 Responsibility:
QC Officer /Executive/ Designee :
• To follow the procedure for Handling of Reference Standards, Impurity standards and System suitability solutions.
• To follow the procedure for Handling of Reference Standards, Impurity standards and System suitability solutions.
• To close the vial properly after usage and store as per required storage condition.
• Maintain reference standard usage logbook.
• To record and maintain all raw data as per procedure.
QC Head / Designee :
• To procure reference standards when it is required.
• To procure reference standards when it is required.
• To verify the current lot of the reference standards from the relative pharmacopeia from the website.
• To review and ensure compliance of SOP.
QA Head / Designee :
• To approve, implement and ensure compliance of SOP.
• To approve, implement and ensure compliance of SOP.
4.0 Procedure:
4.1 Procurement Reference Standard:
4.1.1 Reference standards, are procured from reference pharmacopoeial agencies. (E.g. IP, BP , USP and EP not limited with certificate.)
4.1.2 In case of reference standard is not available from reference pharmacopoeial agencies, manufacturers reference standard with COA can be used for preparing working standard and system suitability solutions.
4.1.3 Reference standard of impurity are procured from the reference pharmacopoeial agencies, manufacturer or from the authorized chemical suppliers, ensuring COA along with the supply.
4.2 Handling of Reference Standards:
4.2.1 After receiving reference standards, check the received quantity against indented quantity and other technical details as per checklist for pharmacopoeial reference standard. In case of not received the COA /MSDS along with the consignment, downloaded from the website. Initiated with date of receipt on reference standard bottle.
4.2.2 After checking the consignment QC officer/Executive shall enter the details in reference standard usage log book.
4.2.3 After opening the reference standard vial, transfer the required quantity of the material and immediately tightly close the vial.
4.2.4 Avoid the handling loss during usage of the reference standards.
4.2.5 After usage, analyst shall entry in the usage log book.
4.2.6 QC Head/designee shall verify the current lot validity of the reference standards from the relative pharmacopeia through the website and take print out of the updated list at every 3 Months.
4.3 Preparation and handling of System suitability Solution :
4.3.1 QC Officer/designee shall prepare the system suitability solution using respective standard test procedure as per the requirement.
4.3.2 For preparation of system suitability solution minimum quantity of reference standard and impurity standard can use by reducing the dilution and mention the preparation details in record.
4.3.3 All System suitability solution consist the unique number as bellow.
ABC/QC/SST/XX/YYY
Where ,
ABC stands for company name
QC stands for Quality control
SST stands for System suitability solution.
XX stands for current year
YYY stands for serial number started from 001, 002 and so on as come in the list..
ABC/QC/SST/XX/YYY
Where ,
ABC stands for company name
QC stands for Quality control
SST stands for System suitability solution.
XX stands for current year
YYY stands for serial number started from 001, 002 and so on as come in the list..
4.3.4 Preserve the SST solution in appropriate glass stopper /Vials and in volumetric flask with proper identification. Label them with the details.
4.3.5 Validity of System suitability solution is 3 months from the date of preparation. After the validity period is over dispose the solution.
4.3.6 QC officer shall prepare the list of System suitability solution and updated the list at every 3 months.
4.4 Storage:
4.4.1 Keep all the reference standard vials at recommended storage condition.
4.4.2 If the storage condition is not mentioned, store the reference standards in refrigerator.
4.4.3 After expiry, discard the remaining quantity of reference standard and record in Remarks Column.
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