Quality Control personnel Responsibilities in Pharmaceuticals
Quality Control in Pharmaceuticals
Quality assurance and quality control are two aspects of quality management and quality assurance and quality control activities are interrelated.
What is Quality Control :
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. It involves in chemical, physical and some time microbiological testing of a pharmaceutical product.
Quality control involves testing of units and determining if they are within the specifications for the final product.
In Quality Control there are different sections like Raw Material, Packing Material, In process, Finished Products, Good Laboratory Practices, Calibration, Specification and Stability etc…
For Good Laboratory Practices pl Refer : https://pharmaceuticalupdates.com/2019/01/20/good-laboratory-practices-glp-rules-for-pharmaceuticals-and-other-quality-control-laboratories/
Responsibilities of Quality Control personnel (But not Limited To) :
To follow the laid down safety precautions while working in the laboratory.
Maintenance or upkeep of Laboratory working area.
Ensure compliance with current Good Laboratory Practices and current Good Manufacturing Practices.
Sampling of Purified / Potable Water and its analysis.
Analysis of Raw Materials (API / Excipients), Analysis of finished Product, Packing Material, In process samples and Stability Sample.
Qualification of Laboratory Instruments and Equipment’s.
Daily Calibration and Monthly Calibration of Analytical Balances and other Instruments.
Preparation of Calibration Schedules and ensure for proper execution.
Sampling and analysis of process validation and cleaning validation samples.
Review and checked all analytical Document like Test Data sheet, Daily and monthly instrument calibration, GLP record etc.
Preparation of Specification of Raw, Packing, In process & Finished products.
Preparation of Standard Test Procedure for Raw, Packing, In process & Finished products.
Reporting of Incidence, Out of Specification and Out of Trend results observed during analysis.
Preparation of Certificate of Analysis (COA) .
Trending of water, Out of Specification and Out of Trend etc.
Preparation of Stability summary after analysis.
Status labeling of Quality control instruments, Chemicals & Glassware.
Disposal of balance samples after completion of analysis and its documentation.
Refer Responsibility of Quality Assurance : https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/
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