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Quality Control

DESCRIPTION OF THE QUALITY CONTROL SYSTEM AND OF THE ACTIVITIES OF THE QUALITY CONTROL DEPARTMENT. PROCESS FOR THE RELEASE OF PRINTED COMPONENTS AND FINISHED GOODS.
The Quality Control Department is part of the Quality Assurance Deparmtment.It is headed by Quality Control Incharge.The major activities of the Quality Control Department are:
  •  Approval/Rejection of raw and packaging materials as per Respective SOP.
  •  Testing of in-process samples as per respective SOP.
  •  Testing of finished goods as per respective SOP.
  •  Carrying out stability studies as per respective SOP.
  •  Testing of water as per respective SOP.

PROCEDURE FOR APPROVAL/TESTING OF RAW MATERIAL
For unloading of the raw material receiving way has been ear marked. There & Then the goods are de dusted & immediately transformed to the sampling area under intimation to the Q.C, after sampling in the sampling booth, the goods are transferred to under test area & yellow labels are affixed on each & every container. As soon as Q.C.Department intimated the result the approved Raw material is shifted to Approved R.M.area. Green Label is affixed on the yellow Label & Simultaneously the rejected goods are shifted to Rejected Areas with Red label affixed on the yellow Label.

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PROCEDURE FOR RELEASE OF PRINTED PACKAGING MATERIAL.
All printed packaging material on receipt from vendor are stored in warehouse with "Under Test status. A Goods Receipt Note for the Goods is made and sent to Q.C.Dept.on the receipt of the goods Receipt Note, the Q.C.Dept.assigns and Analytical Reference Number to sampling .Samples are tested as per the approved specifications and compared with approved standards and shade cards, following standard Test Procedurs.If the samples conform to the specifications, then the consignment is released and an "Released Label is pasted over the "Under Test" label.

PROCEDURE FOR RELEASE OF FINISHED GOODS.
As soon as any batch has been finally packed, the in –process Q.A.Personal draw random samples of the finished goods. These random samples are tested as per approved specifications by the Q.C.Dept.These specifications are normally more stringent that the Pharmacopoeia requirements. If the random samples meet the specification (Known as Product Release Specifications), the Quality Control Department certifies that the goods meet the laid down specifications.

The batch Production Record is then reviewed by the Quality Assurance. He Checks for the completion of the documents and for the compliance with cGMPs at various steps. The QA "Releases the batch for distribution by signing the BPR. For carrying out to above responsibilities the Quality Control Department has been provided with the latest equipments, instruments & Glass wave.

LIST OF Q.C. EQUIPMENTS
Instrument of Laboratory

H.P.L.C. (High Performance Liquid Chromatography).

U.V.Cabinet

UV-Visible Spectrophotometer.

Magnetic Stirrer

Polarimeter

Muffle Furnace

I.R.moisture Balance.

Water Bath

P H Meter

Hot Air Oven

Karl fisher Auto Titrater

Weight Balance

Dissolution Apparatus.

Disintegration Test Machine

Melting Point Apparatus.

Friability Test Apparatus

Ultrasonic Cleaner.

Leak Test Apparatus.