QC | Quality Control in Pharmaceutical Industry

Quality Control in Pharmaceutical Industry

Description of the Quality Control in Pharmaceutical Industry

activities:

• The Quality control in Pharmaceutical Industry is responsible for the following activities:
• Sampling & analysis of Raw materials, IPQC Samples, Packaging Materials and Finished Products.
• Documentation related to sample handling and analysis.
• Preparation & review of Specifications and test procedures for Raw materials, In- process samples,
• Finished
• Products and Packaging materials.
• Preparation & review of QC – SOPs.
• Investigation of QC failures
• Calibrations of the instruments and equipment in the QC laboratory.
• Stability testing.
• Ensuring GLP in laboratory
• Incoming, In-Process & Final Inspection of products.
• Internal Calibration of equipment’s.
• Management of laboratory equipment’s.
• Management of samples. 
• Management of inspection and calibration records.
• Review and approve the Specification and Standard testing procedures.
• Review and approve the Calibration record.
• Review and approve the working standard qualification record.
• Analysis of raw materials/packaging materials/In Process & Finished Products as per the Specification and standard test procedure. View and approve the volumetric solution preparation and standardization record
• Analytical Raw Data and Report of Raw material, in-process, semi-finished and finished product.
• Specification /STP/GTP/TDS of Raw Material /Packaging materials /In Process & Finished Products.

SOP on Handling & Storage of Reference Standards
SOP on Preparation & Storage of Working Standard
SOP on Rounding Off The Digits
SOP on Receipt, Identification, Performance, Utilization And Destruction of HPLC Column
SOP on Procedure For HPLC Column Washing
SOP on Preparation of Indicator Solutions
SOP on Preparation and standardization of Volumetric solutions
Procedure For Cleaning of Sampling Devices
Performance Qualification of Volumetric Air Sampler  
Performance Qualification of Autoclave
Performance Qualification of Bacteriological Incubator 
Performance Qualification of Crystal Panel Viewer
Performance Qualification of Bod Incubator
Performance Qualification of Colony Counter
Performance Qualification of Double Door Autoclave 
Performance Qualification of Heating Block
Performance Qualification of Hot Air Oven
Performance Qualification of Laminar Air Flow
Performance Qualification of Air Born Particle Counter
Performance Qualification of Vortex Mixer