Role of Quality control department in Pharmaceutical Industry

The main purpose of the Quality control the department is checking the quality of the product at every stage of the manufacturing stage during the manufacturing of the product.

Quality of the product means the percentage purity of the product and the impurity presence of the product. 

Calibration of the instruments used in Laboratory:

The instruments are used for the analysis of the sample shall be calibrated and operated as per the standard operating procedure. The instrument calibrations are performed by the QC. and all calibration records are maintained

Sampling:

A sampling of the raw material and the finished product shall be done by the QC person as per the SOP.

Analysis:

Analysis of raw material:

The raw material received should be analyses before it utilize into the manufacturing activity.

Analysis of in-process sample:

To maintain the critical in the processing activity during the manufacturing there is the requirement of the in-process analysis. The in-process analysis is performed by the QC personnel

Analysis of the finished product:

The final sample shall be analyzed and COA shall be prepared. After that procedure material shall be released as per the procedure.

Analysis of cleaning sample:

The equipment used in manufacturing the process shall be cleaned before a new batch is charged. And there should not the availability of previous material hence after cleaning the sample shall be analyzed for the presence of the previous product.

Analysis of packing materials:

The packing material used also tested as per the SOP.

In the API industry, the packing materials are the liners bag and the drums. If the material is liquid then the packing material used is carboys.

For formulation, different types of packaging materials are used.example: for liquid syrup and the suspension glass or plastic bottles are used

Approval or rejection of the material:

After testing of the finished sample if the sample is meet the predefined specifications the QC person approved the material but if the material is not meet the predefined  specification material rejected. The approved or rejected label has been paste on the material.

Preparation different reagent and the solution:

Different solutions and reagents are used in the analysis. Some solutions and indicators are prepared in-house. That solution and reagents are also prepared by the QC personnel and the record shall be maintained 

Documentation of all analysis:

All analysis is done in quality control the lab shall be recorded. Different protocols are available the records of analysis usage log book are used to detail the usage of equipment and which samples are tested

Preparation of the document specification, test method, and the test protocol:

A standard operating procedure, specifications, test method, protocols, formats are the different documents prepared by the QC Personnel received and approved by the QA and master copy shall be kept with QA department. Test method and specification control copy shall be given. Test protocols and formats are issued to the QC department as per the requirement.

Schedule the activity of stability study and Stability study analysis:

 Stability study shall be performed by the QC department. the purpose of the stability study is to evaluate  time duration in which sample retain unchanged (in terms of purity and the impurities ).based on the stability data retest period or expiry date shall be assign.