methods to detect contaminants.

Quality Assurance (QA) Team: Responsible for reviewing the results of impurity testing, approving raw materials for use in production, and ensuring compliance with regulatory and internal quality standards.

4. Accountability

The QC Manager is accountable for ensuring that all raw material impurities are identified accurately and promptly. The Procurement Supervisor is responsible for ensuring the raw materials meet the initial specification and are accompanied by proper documentation. The QA Manager is accountable for overseeing the approval process of raw materials based on impurity testing results.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that all testing equipment, such as analytical balances, pH meters, and chromatography systems, are calibrated and ready for use.
2. Review the supplier CoAs for each raw material to ensure that the materials meet the required specifications for purity. If the CoAs are incomplete or unavailable, initiate additional testing to confirm the purity of the materials.
3. Ensure that all raw materials are stored according to the recommended conditions (e.g., temperature, humidity) to prevent any degradation or contamination prior to testing.

5.2 Sample Collection

1. Collect representative samples of raw materials for impurity testing. Samples should be taken from sealed containers to ensure they are not contaminated.
2. Ensure that the sample is homogeneous and free from any visible contamination (e.g., foreign particles, discoloration).
3. Label each sample clearly with the material name, batch number, sampling date, and the purpose of the test to ensure traceability during testing.

5.3 Impurity Identification Procedure

1. Perform a physical inspection of the sample for visible contaminants (e.g., foreign particles, color changes, or improper texture).
2. Conduct the following tests to identify specific types of impurities:
   • Microbial Testing: Test the raw material for the presence of microbial contamination, including bacteria, yeast, and mold, using appropriate growth media and incubation conditions.
   • Heavy Metals Testing: Test for the presence of heavy metals (e.g., lead, mercury) using atomic absorption spectrometry or inductively coupled plasma (ICP) analysis.
   • Chemical Impurity Testing: Perform chemical tests such as high-performance liquid chromatography (HPLC) or gas chromatography (GC) to identify the presence of residual solvents, pesticides, or other chemicals that may be contaminants.
   • Physical Impurities: Conduct tests such as microscopy or filtration to detect physical contaminants (e.g., glass, plastic, or other particulate matter).
3. Document all test results and the specific methods used in the Impurity Testing Log (Annexure-1).

5.4 Interpretation of Results

1. Compare the test results to the defined specifications for each raw material. The materials should meet the defined limits for microbial content, chemical residues, heavy metals, and physical impurities.
2. If the impurity levels exceed the acceptable limits, mark the test as “Fail” in the Impurity Testing Log (Annexure-1).
3. Investigate the cause of the impurity by reviewing the supplier’s records, production processes, and storage conditions. Determine whether the impurity is due to the raw material itself or contamination during handling or storage.
4. If the raw material passes the impurity test, mark the test as “Pass” and proceed with the approval of the raw material for use in production.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, impurity levels, and corrective actions taken in the Impurity Testing Log (Annexure-1).
2. If the material fails the impurity test, place the material in quarantine until corrective actions are implemented. Communicate with the supplier to resolve the issue, which may include requesting a replacement batch.
3. Ensure that all deviation reports and corrective actions are documented in the Deviation Log (Annexure-2).

5.6 Documentation and Record-Keeping

1. Ensure that all records related to impurity testing are complete, accurate, and securely stored. This includes the Impurity Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Impurity Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs for Raw Material Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Impurity Testing Log

Batch Number	Sample ID	Sampling Date	Test Type	Impurity Level (CFU/g, ppm)	Operator
12345	S-001	21/01/2026	Microbial Test	Pass	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Heavy metal contamination	Contacted supplier for a new batch	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head