3 replies to this topic

[QARegulatoryProfessional]

There are four specific preventive controls outlined with FSMA but from my understanding others may be necessary depending on your facility. Can a CGMP be used as a preventive control (i.e. CGMP - pest control program to prevent the risk of pest infestation)?  

[Kellio]

Not all cGMPs can be a PC Control.  Your PCs are based on Risks. a PC Control must go beyond HACCP's CCPs and CPs. PC's are similar to the OPRP's used in ISO 22000. Just like a CCP, it is must have and it must be monitored, verified, and validated frequently.

 

For Some:

Receiving Raw materials and packaging is a PC Control.

Environmental Testing is a PC Control.

Sanitation is a PC Control.

Labeling (Allergen) is PC Control

Metals Detector is a PC Control

 

The Question is: How is your risk assessment determines the Preventive Control?

 

I hope this helps,

 

Kelio

[CMHeywood]

My opinion is that a cGMP can be part of a control program if you have:

(1)  Documented procedure that describes the control program.

(2)  Documented training - program materials and training records.

(3)  Documented records of the control activities (operator records).

(4)  Documented audit schedule.

(5)  Documented CPAR system.

(6)  Documented management review of the first five.

This accomplishes the monitoring (operator check sheets for example), verification (is being done), and validation (is working effectively).

 

Pest control is a Good Manufacturing Practice.  Some people would consider pest control to be a prerequisite program (PRP) that affects the whole facility, and not a CCP that is implemented at one particular point in the processing.

[smgendel]

GMPs and PCs are different things, and GMPs are NOT preventive controls.  The confusion arises because some types of controls can be either a GMP or a PC, depending on how you use them.  In general, you can think of it in terms of whether the control is general to the facility or specific to products.  For example. general facility sanitation is usually a GMP while allergen cleaning of processing equipment would be an allergen control PC.  Iit is more important to make sure that hazards are controlled than it is to worry about what you call the control.