Analytical methods Good Manufacturing Practice

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

In setting limits for lead and other heavy metals, the committee considers the amount of a food chemical consumed, the feasibility of manufacturing a product within these limits, and the availability of analytical methods to ensure compliance. The constraints of good manufacturing practice and the availability of reliable analytical methods are often limiting factors in setting lower limits for lead and other heavy metals. 

Analytical method transfer should be performed using a validated procedure this transfer data can be useful in determining intermediate precision of the method. The transferring laboratory should ensure that the recipient laboratory(s) is (are) current Good Manufacturing Practice (cGMP) compliant a record of successful audit by QA personnel is essential, especially if the laboratory is a contractor. 

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. 

World Health Organization. Analytical method validation. In Supplementary guidelines on good manufacturing practices validation. Appendix 4. Technical Report Series, Annex 4, No. 937. Geneva WHO 2006. 

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