responsibilities of quality control and microbiological department

1.0 Purpose
1.1 To describe a procedure for assigning responsibilities of Quality Control (Q.C) and Microbiological department.

2.0 Scope
2.1 This standard operating procedure is applicable for assigning responsibilities of Quality Control (Q.C) and

Microbiological department at ABC PVT.LTD.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 Responsibilities of Quality Control Department
5.1.1 To provide the analytical service to the manufacturing and other departments through following activities.
5.1.1.1 Sampling and testing of starting raw materials, packaging materials, and intermediate and,

bulk samples, to assess whether these conforms to the pre-defined release specifications or not.
5.1.1.2 Sampling and testing of finished drug products.
5.1.2 Stability testing of drug products and control samples.
5.1.3 Evaluation, storage and maintenance, of the reference standards, and working standards for APIs.
5.1.4 To calibrate all analytical instruments as per schedule and maintain the record.
5.1.5 To prepare, standardize the volumetric solutions, buffer solutions, indicators etc
5.1.6 To assist Quality Assurance department for conducting laboratory investigations related to

non-conformance, Out of Specification laboratory results and market complaints etc.
5.1.7 To prepare specifications and Standard Test Procedure.
5.1.8 To prepare and maintain laboratory records, (manually and/or by recording instruments)

to demonstrating that all the required sampling, inspecting, and testing procedures have actually

been carried out and that any deviations have been fully recorded and investigated.
5.1.9 To follow the different aspects of cGLP (Good Laboratory practices).

5.2 Responsibility of Microbiological Department
5.2.1 To conduct the Microbiological analysis of raw materials, intermediate samples (if any), and

finished drug products as per the specification.
5.2.2 To carry out microbiological assay determination of raw materials, and drug products.
5.2.3 To conduct the environmental monitoring of manufacturing, quality control and ware house

departments at regular intervals.
5.2.4 To carry out Validation of water system, Clean area, and other validation (i.e. for Microbiological aspects)

in assistance with QA department.
5.2.5 To monitor the microbial Quality of water on regular basis.
5.2.6 To carry out cleaning, sanitization and fumigation of Microbiological department.
5.2.7 To validate the equipments like Autoclave, LAF etc installed in the microbiological section.
5.2.8 To maintain Microbial culture as per the standard test procedures.
5.2.9 To perform testing as per the Standard Testing Procedure (STP’s) and prepare required documentations.
5.2.10 To follow the procedure laid down in the Good Laboratory Manual.

6.0 Reference
In House Specification

7.0 Attachments
Not Applicable

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure

10.0 Revision History