Good manufacturing practice verification

Calibration, in current Good Manufacturing Practices (GMP) terminology, refers to instrument qualification or performance verification... 

Calibration, in current Good Manufacturing Practices (cGMP) terminology, refers to instrument qualification or performance verification of the HPLC. Note that neither any internal instrumental adjustment nor detector response curve for quantitation is intended here as in the common usage of the terminology. In most pharmaceutical laboratories. 

Method validation is covered in the current Good Manufacturing Practices (cGMPs) under section 211.165(e) which indicates that The accuracy, sensitivity, specificity, and reproducibility of tests methods. .. shall be established and documented . Such validation and documentation may be accomplished in accordance with 211.194(a) (2) which includes the need to indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested . Methods included in recognized standard references such as the current USP/NF are understood to be validated. The suitability of all testing methods used shall be verified under actual conditions of use (211.194). For new products for which methods are developed, analytical method validation as described in this chapter will be necessary for methods already included in the USP, method verification will suffice. 

Equipment documentation verification of the technical documentation used during qualification on compliance with basic Good Manufacturing Practice (GMP) rules (6,7). 

Verification of compliance of investigational medicinal products with good clinical and manufacturing practice... 

G. Inspections, Verification of Compliance of Investigational Medical Products with Good Clinical Practice and Good Manufacturing... 

Quality control refers to that part of good pharmaceutical manufacturing practices concerned with the operations of verification of quality levels acceptance or rejection of raw materials, acceptance or rejection of semifinished or finished products, estimation of the stability of products, examination of returned products and supervision of retained sample stores. 

Many manufacturers now serve the market. Some of these offer standard units for well-proven applications, or for the user to determine their suitability. Others design for use, based upon experience and good practice. While many similar types of applications recur, permutations of the range of bulk products with differing applications and environmental conditions are so vast that it is common to find new duties for which no prior identical example of use can be drawn upon for performance verification. In such circumstances, the application criteria and basis of specification need to be established with some precision, as no feeder, screw type machine, or indeed any other form of handling equipment, can guarantee to handle a bulk material of unspecified condition. 

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