STANDARD OPERATING PROCEDUREMicrobial Testing of Raw Material, Packing Materials, Finished Product, and Stability Samples

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/xxxx
Microbial Testing of Raw Material, Packing Materials, Finished Product, and Stability Samples		Effective Date:
		Review Date:
		Page No.:

 

1.0            OBJECTIVE:

1.1                       To lay down a procedure for the microbiological testing of raw materials, packing material, finished product and stability samples.

2.0            SCOPE:

2.1                       This procedure is applicable to microbiological testing of raw materials, packing materials, finished products and stability samples.

3.0            RESPONSIBILITY:

3.1                 Microbiologist – Responsible for analysis and reporting the results.

3.2                 Section in-charge – Responsible for review the activity and results.

3.3                 QC Head – Responsible for implementing the Procedure.

3.4                 QA Head – Overall compliance.

4.0            PROCEDURE:

4.1                       After receiving the samples of packing materials, raw material, finished and stability entry shall be done in respective inward registers.

4.2                       Raw materials and packing materials shall be entered in Annexure I (Raw Material inward register).

4.3                       Finished Products and Stability samples shall be entered in Annexure II (Finished Products inward register).

4.4                       Allotment of M.R. No. shall be MX/YYZZZ, where M stands for micro, X stands for material (raw material, packaging material- R, Finished product, Stability, Blending, core, coated, packing strips - F) YY stands for academic year, ZZZ -sequential number starting from 001 for respective material.

4.5                       Preparation of microbial media:

4.5.1                 Prepare and sterilize the required media as per current version of SOP QC/MB/xxx Preparation and sterilization of Microbial Media.

4.6                       The material shall be tested for Total Aerobic Microbial Count (TAMC), Total Yeast & Mold Count (TYMC) and Test for specified micro-organisms as per pharmacopeia status and specification.

4.7                       Analysis shall be carried out as per current version of general test procedure GP/043.

4.8                       After Completion of microbial analysis certificate of analysis shall be made as per finished product / raw material specification.

4.9                       Raw data for microbiological analysis for raw materials and packing materials, finished products, and stability samples shall be written in Annexure IV.

4.10                   Microbiological Test report for raw materials, packing materials, finished products, and stability samples shall be prepared in Annexure III.

4.11                   If any sample is positive for any specified micro-organism, perform the confirmatory test.

4.12                   The results of the confirmatory tests shall be recorded in Annexure VI.

4.13                   If any results fail to meet specification, an out of specification shall be carried out as per current version of SOP QA/GN/014.

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	MB: Microbiology

7.0            REFERENCES:

7.1                       European Pharmacopeia chapter 2.6.12 & 2.6.13 (Microbiological Examination of non-sterile Products: Microbial Enumeration test and Test for specified microorganisms).

United States Pharmacopeia Chapter <61> &<62> (Microbiological Examination of non-sterile Products: Microbial Enumeration test and Test for specified microorganisms)