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Appendix D: Pharmaceutical Analysis

The pharmaceutical industry operates under the cGMP laws, guidance and regulations. These incorporate many of the requirements in ISO/IEC 17025. Both pharmaceutical cGMP and ISO/IEC 17025 are based on good science and sound metrological practices. The United States regulations in the 21CFR 211 Subpart 1, Laboratory Controls, 211.160 b) state

Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

ISO/IEC 17025 and cGMP align in most requirements; hence, a laboratory meeting cGMP requirements will meet many ISO/IEC 17025 requirements. In this ALACC guide, additional information is added for the pharmaceutical industry to indicate these similarities, differences or point to a cGMP system that meets an ISO/IEC requirement. It is not practical to identify all the cGMP documents and systems that address the ISO/IEC 17025 requirements, so only the most relevant are identified.

The following are such requirements:

a. Decision rules

i. Decision rules are not required in the cGMP. They are discussed in USP stimuli article “ Fitness for Use: Decision Rules and Target Measurement Uncertainty ”; USP Pharmacopeia Forum 42(2), Stimuli Article, usp.org

b. Proficiency testing (PT)

i. PT is not required in cGMP but is required for ISO/IEC 17025.

c. Quality control checks (independent checks)

i. The cGMP guides provide information on confirmatory checks, such as System Suitability checks. ISO/IEC 17025 provides additional information on what these checks are and how to use them. i. In cGMP equipment qualification follows a rigorous qualification program including Installation Qualification/Operational Qualification/Performance Qualification ii. In cGMP autoclave validation and water purification are rigorously described i. The evaluation and use of measurement uncertainty are required in ISO/IEC 17025. ii. The USP published a Pharmacopeia Forum stimuli article on Measurement “Uncertainty for the Pharmaceutical Industry” ; USP Pharmacopeia Forum 44(1), usp.org

d. Equipment Qualification

e. Measurement uncertainty & Target Measurement uncertainty

08/09/2018