Analysis of Raw Materials

1.0 OBJECTIVE :

To describe the general procedure for Chemical and Microbiological Analysis of Raw Materials.

2.0 SCOPE :

This procedure gives guidelines for Analysis of active drugs and excipients being used in various formulations in order to confirm the characteristic that will provide the desired quality in dosage forms produced.

3.0 RESPONSIBILITY :

Quality Control Chemist and above

4.0 ACCOUNTABILITY:

Quality Control Head

5.0 PROCEDURE :

5.1 Verify Goods Receipt Note, Vendor’s name in list and Vendor’s certificate of analysis.

5.2 The details of Goods Receipt Note shall be entered in Raw Materials Register. Analytical Report Number shall be allocated and sampling of raw material shall be performed as per SOP of Sampling of Raw Materials.

5.3 Testing of materials

Raw material section head shall assign chemist/microbiologist for analysis.

The sample shall be handed over to assigned chemist / microbiologist with Goods receipt note (GRN), specification and analytical work sheet.

Analytical work sheet shall be issued by the document cell of QC department.

Chemical and instrument analysis shall be conducted in quality control department in respective section as per respective specification.

Microbiological analysis shall be conducted in the Microbiological section.

Raw material shall be analyzed under supervision of approved chemist as per given specification, which may be as per Pharmacopoeia or/and as per In-house specification.

Identification test shall be performed for all samples individually in case of active Ingredient.

All other tests will be performed by using pooled sample for analysis after completion of identification test.

Raw material analysis should be initiated within a week from the date of sampling.

The following precautions to be taken if the raw material is not analyzed within the time frame.

The samples should be stored at adequate storage conditions.

It should be ensured that the container used to store a sample should not interact with the sampled material nor allow contamination.

The container should also protect the sample from light, air and moisture, as required by the storage direction for the pharmaceutical product or related material sampled.

The container should be labeled with respect to sampled material.

The raw data of chromatographic analysis, system generated data from the software shall be printed out and attached with analytical worksheet by the Analyst.

The report of contract laboratory shall be checked and complied, wherever applicable and attached with analytical worksheet.

The report will be signed by officer and above for correctness.

The results and other required details will be entered in respective worksheet.

Checklist for Raw Material Analysis completion shall be filled by an Analyst and attached as 1st page on compiled analytical data.

Completed document as analytical report shall be submitted to raw material section head.

The analytical report shall be checked by Competent Technical Quality Control staff and authorized by FDA Approved competent technical staff-Quality Control.

6.0 ABBREVIATIONS:

Abbreviation Expanded form

SOP Standard Operating Procedure

No. Number

QC Quality Control

COA Certificate of analysis

GRN Goods Receipt Note

FDA Food and Drug Administration

7.0 ANNEXURES

Annex. No. Title

01 Checklist for Raw Material Analysis Completion

8.0 SOP REFERENCES