Standard Operating Procedure for Analysis and Release of Raw Materials

Standard Operating Procedure for Analysis and Release of Raw Materials
Standard Operating Procedure for Analysis and Release of Raw Materials

Standard Operating Procedure for Analysis and Release of Raw Materials

1. Purpose:

To lay down a procedure for Analysis and Release of Raw Materials.

2. Scope:

The scope of this is applicable document is to provide the procedure for Analysis and Release of Raw Materials in quality control laboratory at [company name].

3. Responsibility:

QC Analyst: Analysis of raw materials

QC Supervisor: Allocation of raw material sample, submit samples to analyst for analysis

QA Reviewer: Review the data.

QC Head: Approval of raw materials, and ensure the compliance of this SOP.

4. Definitions:

Not Applicable

5. Procedure:

• Raw materials must always be examined in accordance with the specifications.

• Raw materials heaving test with tests where % Water content or % Loss on Drying (LOD) test available shall be analyzed first.

• All raw materials must be analyzed within one month period once sampling is done.

• If raw materials are not released within a month after the date of sampling, the delay in material release must be justified. It must be recorded in the “Extension Request Form for Raw Material Release” format (Refer respective format).

• The raw material department in charge will provide a time schedule for the completion of the task.

• The justification for the delay must be examined and approved by Head QC and the Head QA.

• Whenever label is required to re-generate and Certificate of Analysis (CoA) to be re-printed from the Laboratory Information Management System (LIMS) system, it must be appropriately explained.

• The QC Analyst should conduct the analysis and data input in the LIMS.

• The QC Analyst shall print Approved/ Rejected label from LIMS based on analysis results.

• Supervisor of Raw material shall allocate the sample to QC analyst through LIMS for analysis of Raw material.

• Supervisor shall handover the sample to analyst to carryout analysis.

• Raw material all containers shall be analyzed for identification test. 100% containers shall be analyzed for identification using any one representative identification test.  

• Identification test shall be performed for all the sub composite sample shall be done before analysis of composite sample. 

• A composite sample of all containers shall be analyzed in accordance with the specifications.

• QC analyst shall perform the analysis and enter the data details in LIMS.

• For Raw material under scope of reduced/ skip lot testing:

• For raw material API, each container of the batch must be examined for identification using FT-NIR/ Raman.

• The appearance and identification of the composite sample must be accomplished in accordance with the specifications. The results of any additional tests required by the specification must be transcribed from the manufacturer’s COA, which is received with the shipment.

• The QC analyst must record the findings of the FT-NIR/ Raman tests in the LIMS.

• If the FT-NIR/ Raman is under maintenance, the 100% sample should be performed at the QC laboratory using FTIR.

• If the material fails the identification test using FT-NIR Raman, complete testing must be performed in accordance with the corresponding specification before reaching a decision on batch approval/rejection of the material.

• Raw material API eligible for skip lot testing should be fully tested at the specified period (every 5th, 10th, or 20th batch) as required by respective specification.

• If a confirmed failure is discovered for a product under the scope of rationalized testing, complete testing of the material will be commenced for the next three batches received from the manufacturer. If the data is judged to be adequate, skip lot testing can be restarted following a review of the full API testing and risk assessment to re-start the reduced testing.

• After completion of analysis, QC reviewer and QA shall review the data in the LIMS as well as audit trail in the respective instruments.

• On completion of checking, Raw material shall be Approved or Rejected by QC head in the LIMS.

• QC analyst shall print Approved or Rejected label from LIMS and affix labels on all the containers of the Raw Material.

• Content of Approved label are Material Name, Material Code, A.R. No., Manufacturer, Mfr. Batch No., Mfg. Date, Exp. Date, Quantity, Retest Due On, No. of containers, Printed on, Date

• Content of Rejected label are Material Name, Material Code, A.R. No., Manufacturer, Mfr. Batch No., Mfg. Date, Exp. Date, Quantity, Reason for Rejection, No. of containers, Printed on, Date

• In case Raw material is rejected because of quality issue, Rejection Report shall be prepared by QC person and inform to QA and Head Warehouse. 

• In case of any test of any raw material to be carried out at Contract Testing Laboratory, it shall be sent to contract testing laboratory as per approved list. Ensure that applicable test is allocated to approved laboratory where the specific test is allowed as per the list.

• Analysis and release procedure for Nitrogen gas:

• In case of any test where assay or potency limit is ± 5%- or one-sided limit, evaluate the results of QC test against manufacturer’s COA. Both the results must not differ by ± 2%. In case it is differed by more that this criterion, it shall be investigated.

6. Frequency:

On receipt of new material or during retest

7. Formats:

7.1 Approved Label

Material Name

Material Code

A.R. No.

Manufacturer

Mfr. Batch No.

Mfg. Date

Exp. Date

Quantity

Retest Due On

No. of containers

Printed on

Date

7.2 Rejected Label

Material Name

Material Code

A.R. No.

Manufacturer

Mfr. Batch No.

Mfg. Date

Exp. Date

Quantity

Reason for Rejection

No. of containers

Printed on

Date

7.3 List of Raw Materials under scope of Rationalize testing

Sr. No.

Name of Material           

Code No.           

Effective Date

7.4 Extension request form for release of Raw material

Material Name

Material code

A.R. No.

Date of Sampling

Summary of Test Completed to as on Date

Test pending

Justification for Extension Request

Timeline for completion of all the tests

Requested by

Reviewed by Head QC

Approved by Head QA

To refer more similar procedures of quality control laboratory, click here.

To refer more SOP of Pharmaceutical Industry, click here

Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

WHO guidelines for sampling of pharmaceutical products and related materials

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