Regulatory Overview

1. Regulatory Overview

2. 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 Why list all departments?

3. 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

4. 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

5. GLP • Good Laboratory Practices • Prescribes practices for conducting non clinicallab 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

6. 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

7. 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

8. 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

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