Basic orientation training to introduce employees to GMP.

1. GMP Orientation
Presented by
Alameda Chemical

2. Why GMP?
► ACS has decided to venture into FDA
regulated materials
► FDA materials are highly regulated
► ACS must develop and follow strict
procedures to ensure the safety and
integrity of the FDA regulated materials
under our control
► ACS must provide adequate training

3. What are GMP’s?
► GMP or Good Manufacturing Practices are
control measures used to ensure the
quality, safety, purity, and efficacy of
pharmaceutical products.
► GMP’s are much like our quality procedures,
only they are geared toward FDA regulated
materials and processes

4. GMP Regulations and FDA
►A brief review of the GMP section of the
FDA regulation under 21 CFR 211.

5. Organization
and Personnel
► Responsibilities
of QC Unit
► Personnel Responsibilities
► Personnel Qualifications
► Consultants and Contractors

6. Buildings and Facilities
► Space
► Lighting
► HVAC
► Plumbing and Water
► Sewage and Refuse
► Toileting Facilities
► Sanitation and Maintenance

7. Equipment
► Design
► Construction
► Cleaningand Maintenance
► Automatic, Mechanical, and Electronic
Equipment
► Filters

8. Control of Components, Drug Product
Containers, and Closures
► Receipt
► Testing
► Use
► Storage
► RejectedMaterials and Retesting
► Requirements
► Drug Product Containers and Closures

9. Production and
Process Controls
► Charge In
► Calculation of Yield
► Equipment Identification
► Sampling
► Time Limitations
► Control of Microbiological
► Contamination
► Reprocessing

10. Packaging and
Labeling Control
► Inspections
► Issuance
► Pre-use Inspection
► Tamper-resistant Packaging
► Drug Product Inspection
► Lot Numbers
► Expiration Dating

11. Holding and Distribution
► Storage and Warehousing
► Inventory Control
► Environmental Control

12. Laboratory Controls
► Testing and Release
► Specifications
► Stability Testing
► Contamination Testing
► Reserve Samples

13. Records and Reports
► General Requirements
► Logs – Equipment Cleaning and Use
► Component, Drug Product Container, Closure, and Labeling
Records
► Master Production and Control Record
► Batch Production and Control Record
► Production Record Review
► Laboratory Records
► Distribution Record
► Complaint Files

14. Returned and Salvaged Drug
Products
► Returned Product
► Salvaging Drug Products
► Documentation
► Summary:
Do it Right
Document It
Disclose Errors

15. Contamination Control
► What is Contamination Control?
► Adulterated Drugs

16. Types and Sources of Contamination
► Food Adulteration
► Food Consumption Rules
► Pest Control
► Restricted Personal Items
► Restricted Substance Items
► Contamination Categories

17. Examples of Contamination
► Glass Shards
► Metal Shards
► Hair
► Mold
► Bacteria
► Campylobacter
► Streptococci
► Listeria
► E. Coli

18. Building and Facilities
► Environmental Controls
► Cleaning
► Housekeeping
► Sewage and Refuse

19. Personnel Responsibilities
► Hand Washing
► Illness and Lesions
► Clothing and Gowning

20. Raw Materials
and Components
► Testing
► Component Cleaning

21. Contamination Summary
► Quality
► Purity
► Safety
► Efficacy

22. Proper Documentation Practices
► Regulations:
Predicate Rule
Documentation Retrieval
Inspection by FDA
Retention
Preservation
Formats

23. Required Documents
► Review Required ACS Documents here once
established

24. Organization
and Personnel
► Overview
 Which GMP’s affect people
► Organization
 The Quality Unit
► Personnel
 Staffing
 Training
 Consultants and Contractors
► Personnel Hygiene
 Clothing
 Rest Rooms
 Hand Washing
 Illness and Lesions