Quality control

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QUALITY CONTROL (Q.C.):

QUALITY CONTROL (Q.C.) PRESENTED BY VIKAS JADHAV YASH INSTITUTE OF PHARMACY AURANGABAD DEPARTMENT OF PHARMACEUTICAL ANALYSIS

Contents:

Contents Quality Quality Control Q.C. throughout production system Role of Q.C. Q.C. in an analytical testing laboratory I.P.Q.C

Quality:

Quality Definition : Quality should be built into product & testing alone can not be relied onto ensure product quality. Where from the ‘ Quality comes ’ ? How to achieve Quality ?

QUALITY CONTROL (Q.C.):

QUALITY CONTROL (Q.C.) Definition : Q.C.is the part of GMP concerned with sampling, specifications, testing, with the organization, documentation and release procedures which ensure that the necessary and relevant test are actually carried out and that materials are neither released for use, nor products released for sale or supply, until their quality has been satisfactory.

Steps In Q.C.:

Steps In Q.C. Steps involves – 1) Choosing the control subject 2) Choosing an unit of measure 3) Setting a standard value 4) Providing device 5) Conducting actual management 6) Interpreting the mean between the actual and standard 7) Taking decision and acting on difference

Q.C. Throughout Production Systems:

Q.C. Throughout Production Systems Raw Materials, Parts, and Supplies Production Processes Products and Services Inputs Conversion Outputs Control Charts and Acceptance Tests Control Charts and Acceptance Tests Control Charts Quality of Inputs Quality of Outputs Quality of Partially Completed Products

Role of Q.C.:

Role of Q.C. Establish, validate, and implement all the Q.C. procedure, maintain sufficient standards and reagents. Evaluate, maintain, and store reference and working standards for substances. Ensure the correct labeling of containers of materials and products. Ensure that the stability of API and product is monitored . Participate in the investigation of complaints related to quality of product. Participate in environmental monitoring.

Q.C. In an Analytical Testing Laboratory:

Q.C. In an Analytical Testing Laboratory Manpower. Laboratory standard. Calibrated instruments. Safety in operations. Analysis cost. Laboratory data capture and details of data.

I.P.Q.C.:

I.P.Q.C. To assure batch uniformity and integrity of drug products. Process control and their limits Test and examination to be conducted Appropriate sampling procedures for I.P.Q.C. materials of each batch

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