SOP on Responsibilities of Quality Assurance & Quality control

1.0 Purpose: This SOP describes the basic responsibilities of Quality Assurance and Production Chemists. 

2.0 Scope: This SOP applies to all Quality Assurance and Quality Control staff. 

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: None

5.1.1 It is the responsibility of the Quality Assurance to ensure that the quality policies adopted by the company are followed.

5.1.2 It is the responsibility of the Quality Assurance to keep contact with regulatory agencies and authorised for product acceptance and rejection

5.1.3 It is the responsibility of the Quality Assurance to identify and prepare the necessary SOPs relative to the control of quality.

5.1.4 It is the responsibility of the Quality Assurance to determine that the product meets all the applicable specifications and that it was manufactured according to internal standards and the GMPs.

5.1.5 It is the responsibility of the Quality Assurance for quality monitoring or audit function and it will determine that operations have adequate systems, facilities, and written procedures to control the quality of products produced.

5.1.6 It is the responsibility of the Quality Assurance to determine that the procedures are current and correct, and properly trained operators are following them.

5.1.7 It is the responsibility of the Quality Assurance to audit the facilities and operations and report to Managing director for the level of compliance and will allow the necessary changes and / or corrections to be made prior to either causing a product failure or being reported as a deficiency during an inspection

5.2.01 Quality Control chemist is responsible for the day-to-day control of quality within the company and to maintain relevant records.

5.2.02 Quality Control chemist is responsible for the analytical testing of incoming raw materials and inspection of packaging components and to maintain their relevant records.

5.2.03 Quality Control chemist is responsible to conduct in-process testing, perform environmental monitoring and inspect operations for compliance.

5.2.04 Quality Control chemist is responsible to conduct the required tests on semi-finished and finished dosage form.

5.2.05 Quality Control chemist is responsible for the sampling of raw materials, packaging materials, semi-finished or finished products for analytical testing control.

5.2.06 Quality Control chemist is responsible for the physical inspection of product and operations at the critical stages and control of product through its distribution.

5.2.07 Quality Control chemist is responsible for maintenance and calibration of the equipments and instruments in the laboratory.

5.2.08 Quality Control chemist is responsible for preparation of detailed specifications for testing of packaging components.

5.2.09 Quality Control chemist is responsible, as part of its testing and inspection functions, for monitoring the environmental conditions under which products are manufactured. Quality Control chemist is also responsible to establish the different levels of control depending on the intended use of the dosage form.

5.2.10 Quality Control chemist is responsible to control the packaging components especially those that come into direct contact with a product. These standards should be tested against rigid specifications to ensure that they meet predetermined functional standards.

5.2.11 Quality Control chemist is responsible to control the functions of following stores:

a. raw material

b. packaging components

c. finished goods

5.2.12 Quality Control chemist is responsible for the collection of retention samples of finished goods and to maintain the relevant  records. 

5.2.13 Quality Control chemist is responsible for the storage & maintenance of controlled / retention sample and to maintain the relevant records. 

5.2.14 Quality Control chemist is responsible to establish the stability of raw materials and finished products and to maintain the records of all the tests performed.

5.2.15 Quality Control chemist is responsible to examine the batch manufacturing records to ascertain that the goods manufactured are in compliance with the master formula & GMP regulations.

5.2.16 Quality Control chemist is responsible to maintain the day to day records of samples received in the laboratory and tests required for testing in a note book.

5.2.17 Quality Control chemist is responsible for procurement of needed items in the laboratory in accordance with the established company’s procedures.

5.2.18 Quality Control chemist is responsible to maintain work areas in neat and orderly condition.

5.2.19 Quality Control chemist is responsible for the preparation of working standards and maintenance of their records.