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

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

QSRTrainingManagement ResponsibilityDesign ControlProcess ControlInspection, Lot traceability

cGMP and QSR are essentially the sameMandated by FDA; only in US