Quality Programs

The Quality Program approach should be used for all CGMP activities. The FDA and the ICH have guidelines^1,2 regarding this approach (see Appendix C). The Quality Programs are major sets of plans that are needed for a successful process validation program. Table 4.4 lists some of the more common Quality Programs needed for a well-rounded process validation.

 

Table 4.4

Basic Quality Programs

Calibration

Change control

Cleaning

Document control

Preventive maintenance

Receiving

Sampling

Shipping

Training

Validation

Warehousing

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Related

Related posts:

1. of PV
2. Abstract
3. Process Development
4. Notes

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