Facility RA

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

Hi All,

I am a fresher in pharma consultancy and want to know is there any protocol for preparing Facility Risk Analysis? what all parameters do we have to consider while preparing these documents and performing these activities?

Best Regards
Suave

2

Dear Suave,
Please consider the following Risks for facility

-Risk of Finance
-Risk of Marketing
-Risk of Environment
-Risk from Labour
-Risk of Design
-Occupational exposure Risk
-Risk of Finished Goods Storage & Transporting (Logistics)
-Risk of Power Failures & Power Generation.
-Risks of Raw material Storage & Usage of Materials
-Risks of Cross contaminations
-Risks during Process & Processes.
-Risks of External quality control Testing
-Risks of Training
-Risks of Civil constructions
-Risks from Utilities and Miantenance

These are not limited. But these gives you an overall idea where and what you are building.

Regards

3

Suave

Beware; there is much nonsense talked about risk assessments in the pharmaceutical industry. To actually think about a risk assessment (RA) for a facility makes me think someone is seriously miss-directing you. A RA for a facility would be an enormous, unwieldy and impossible to control document.

RA’s are used in many forms and at many stages from the initial product concept through to the final supplying of the product to the end user.
There are many forms of RA; some extremely complicated, some quite basic and simple. The first thing you must do is document what you are trying to assess. Sounds simple, but so many people go off in tangents; talking about a multitude of different risks.

In validation we use risk assessments to allow us to document our rationale for the scope of validation we intend to apply to a piece of equipment / a process / a software program / a utility / part of a facility.

So the risk assessment must look at the subject matter and decide whether it needs an in depth degree of validation because it is complex and could have an unseen deleterious affect on the final product, or whether it could have no such effect and only requires basic verification to verify that it is fit for purpose.

That is the risk assessment we are directed by the FDA in GMP to put into place and use. This gave us the much sought ability to vary the degree and intensity of the validation task; based on the outcome of such a documented risk assessment (which the regulators have the right to review).

There is no point at the validation stage in considering other risks - they would be adequately considered at the appropriate time in the products design and or development.

Alex Kennedy

4

Alex,
You must also understand and oblige soon as it becomes a "Necessary Evil or Ghost " in pharma & Bio-Pharma Industry.
Total FDA is talking about it and this includes big pharma gaints.
In the year 1970 when “Validation” concept was introduced into Aseptic or Sterile manufacturing areas pharma Folks have similar thoughts. By early 1980’s it took its place into Non-Sterile manufacturung too.
I can tell you the change is slow and inevitable even we agree to that or not.Soon we will travel with this tide.
The only problem with this topic is that the awareness and Knowledge is very limited and its in packets.ISPE has launched the Risk guides so that this topic will be seen as an important topic.
I certainly agree to your point that Facility RA is an enormous task.It cannot be put on a white sheet in a single day or single shot.

5

Quality Risk Management for Facilities, Equipment and Utilities Design of facility/equipment

“To determine appropriate zones when designing buildings and facilities, e.g.,

[b][COLOR=“blue”]- flow of material and personnel;

  • minimize contamination;
  • pest control measures;
  • prevention of mix-ups;
  • open versus closed equipment;
  • clean rooms versus isolator technologies;
  • dedicated or segregated facilities/equipment.[/color][/b]

[b][COLOR=“darkred”]To determine appropriate product contact materials for equipment and containers (e.g., selection of stainless steel grade, gaskets, lubricants);

To determine appropriate utilities (e.g., steam, gases, power source, compressed air, heating, ventilation and air conditioning (HVAC), water);

To determine appropriate preventive maintenance for associated equipment (e.g., inventory of necessary spare parts).”[/color][/b]

Regards

6

Please provide any report for facility and utility risk assessment