1. Quality Systems in a Production Facility
Chapter 7

2. Issues relating to resources
Facilities and Equipment
Process must flow in an orderly fashion
Storage of approved and unapproved raws
Storage of sterile and nonsterile items
Control of environmental factors
Humidity
Temperature
Dust
Accommodate equipment and personnel

3. Facilities, continued Good housekeeping
Clean
Pest and rodent control
Environmental monitoring and control
Suitable equipment that is maintained and where needed calibrated
Thermometers
Scales

4. Raw materials Raw materials are considered to be resources
Flow in, transformed to product, flow out
Receive  quarantined  tested  approved  used for production
Disapproved  returned to supplier

5. Raw material handling Must be labeled upon arrival to avoid confusion
Raws must be tested and found to conform to specifications before they are used by production
Storage conditions must avoid material hazards and address perishabiltiy issues
Traceability of materials must be assured

6. Specifications
Descriptions that define and characterize properties that a product must possess based on its intended use
Specifications for the same property may vary depending on use
Specifications are associated with analytical methods
Specs are written as ranges due to variations from product to product

7. Establishing specifications
Is a key element for any quality program
Establish specs by:
Defining characteristics of product
Document those specifications
Ensure that specifications are met
FDA scrutinizes specs for regulated products

8. Processes Products are made by processes
Processes are a set of interrelated resources and activities which transform inputs into outputs
Process must include monitoring
Critical points or points of control
In process testing
. pH control of oxidation
Use of oxygen rather than nitrogen

9. Validation of Processes and Equipment
Goal of Validation is to ensure that product quality is built into a product as it is produced
Process validation is defined “as establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specs and quality attributes” (FDA)

10. Steps for designing a process Table 7.3
Define purpose of process
Define the endpoint of the process
Select a method to define/measure desired endpoint
Establish specs for raw materials
Determine steps for the process
Scale up process from lab to plant scale
P-116

11. Continued Analyze potential problems
Determine operation at critical points
Develop methods to monitor the process
Develop methods to control the process
Develop effective record keeping of process
Write and approve all SOPs required for the process

12. Items to be validated Table 7.4
Processes (Unit operation)
Cleaning and sterilization
Fermentation
Purification, packaging labeling of product
Analytical methods
Mixing and blending
Major equipment
Heating, venting, and air conditioning
Water purification
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13. Continued Tests and assays Autoclaves and steam generators
Computers that control manufacturing
Freeze dryers
Tests and assays
Microbiological assays
Contaminant tests
Raw materials analyses
Final product tests

14. Validation of process Occurs when process is in place
Requires a validation protocol
Validation protocol is a document which details how the validation tests will be conducted
Equipment must be validated
Installation qualification
Operational qualification

15. Components of a validation protocol, Table 7.5
Description of process
Explanation of features of process to evaluate
Description of equipment, raws, and intermediate products that are evaluated
Explanation of sampling
Procedures for tests and assays
P-120

16. Continued
Explanation of how results of the assays are to be analyzed including statistical methods
A statement of how many times a test is repeated
SOPs describing how to run the process
Give students a description of a process (cookie baking) and have them validate