Laboratory OPERATIONS

Laboratory operations, whether internal at a manufacturing facility or external at a contract laboratory, are an essential part of Current Good Manufacturing Practice (cGMP) requirements that have been promulgated by the Food and Drug Administration (FDA) for dietary supplements and pharmaceutical drugs. 

• Subpart J of 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is assigned as the Production and Process Control System: Requirements for Laboratory Operations.
• In 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart I is dedicated to Laboratory Controls.

Although tobacco specific cGMPs, which will be referred to as Tobacco Product Manufacturing Practices (TPMPs) have not yet been promulgated by the FDA, it is clear that laboratory operations are also already an essential part of tobacco manufacturing requirements. 

• Section 915(b) - Testing, Reporting, and Disclosure of the Family Smoking Prevention and Control Act (Tobacco Control Act or TCA) of 2009 states that the regulations promulgated “shall require testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents.”

All of this emphasis on the laboratory and testing is because the reason material (ingredient, component, constituent, and additive) and finished product testing is conducted, is to determine whether required regulatory specifications have been met. Only products that have been demonstrated to meet all finished product specifications can be approved for release and distribution by the Quality Unit. 

It is therefore, imperative that the laboratory facilities, equipment, operational procedures and processes, and test methods are appropriate for their intended use. All laboratory personnel must also be qualified to perform their assigned job function. Moreover:

• Dietary Supplement test methods must be demonstrated to be scientifically valid;
• Pharmaceutical Drug test methods must be validated or verified, for United States Pharmacopeia – National Formulary (USP-NF) compendial methods Discussing a Lifecycle Approach to Validation and Verification of Analytical Procedures | Quality Matters | U.S. Pharmacopeia Blog (usp.org); and
• Tobacco test methods should undergo a validation or verification in accordance to the FDA Center for Tobacco Products (CTP) Draft Guidance for Industry, Validation and Verification of Analytical Testing Methods Used for Tobacco Products

Written procedures must also be in place for all laboratory operations, including for valid test methods, and documentation of the performance and results of each test method must be provided contemporaneously. 

TLC Regulatory and Laboratory Consulting has extensive experience with the development, improvement, and implementation of a laboratory facility that is compliant with cGMPs;, and the performance and evaluation of test method validations and verifications for the FDA regulated industry.