1. Regulatory Overview

2. 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

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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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