Regulatory Overview

Why list all departments? Manufacturing Quality Assurance Quality Control Chemistry Microbiology Inspection Regulatory Audits Clinical Trials FDA filings Materials Management Receiving Distribution Inventory Control Human Resources Finance Sales and Marketing Management Research and Development

Regulations Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Current Good Manufacturing Practices (cGMP) Quality System Regulations (QSR) International Organization of Standarization (ISO)

Standard Operating Procedures: SOPs Procedures for the following: Manufacture the product Test and release the product Train personnel Label and packaging the product How to handle non conforming product How to design new products

Standard Operating Procedures Good SOPs contain the following: Purpose or scope Materials Procedure Must be written in proper order Must include sufficient detail for operator to follow Should include “checkers” for calculations Must include initials and signature of operator Must have Supervisors review and sign off\ Should be reviewed and updated as needed

GLP Good Laboratory Practices Prescribes practices for conducting non clinical lab studies that support or are intended to support applications for research or marketing of regulated products. Required for research applications to be submitted to the FDA Intended to assure the quality and integrity of safety data filed Does not include human studies or clinical studies

Good Laboratory Practice 21 CFR PART 58 Intended to support applications for research or marketing permits for products regulated by the FDA Including food and color additives Including animal food additives Including toxic drugs Including medical devices for human use Including biological products and.. Including electronic products Not used for basic research

Examples of what’s included Good lab practices Labeling reagent bottles w/ proper info. Reagent name, date, initials or name of who prepared it Equipment monitoring Calibrated, cleaned and verification logs Written procedures Filled out, reviewed by QA, and maintained Personnel should be qualified or at least knowledgeable

QSR QSR: Quality System Regulations Standard produced by the FDA which companies MUST follow Include standards such as training, document control, process control, design control

QSR QSR cGMP and QSR are essentially the same Training Management Responsibility Design Control Process Control Inspection, Lot traceability cGMP and QSR are essentially the same Mandated by FDA; only in US

ISO Similar to QSR International standard Voluntary Provides marketing edge and is well received by customers Risks: failure or loss of certification, add’tl expense