Change control vs Deviation system

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi I have a question on change control if anyone can help. We currently have a separate procedure for our deviation system which currently handles our temporary changes and emergency planned deviations or changes. I am currently revising the change control system and some people on site argue that temporary changes and emergency changes should be handled by our change control system not within a deviation system.

The argument for the current set up is that it is linked to the change control system and CAPA system (activities or document changes required due to the deviation), the system is working (all emergency changes and temporary changes are raised and approval for the planned deviation is required from QA before it can be implemented (it even covers the procedure for if QA are not available).

The question therefore is this sufficient or should we be looking to incorporate these situations into change control?

Any thoughts?
:confused:

2

To understand the concept you must know some terms which are commonly used in Pharmaceutical Manfacturing companies :
CHANGE
ALTER
MODIFY
REPLACED BY
ADDED
REMOVED

When ever such terms apply or applicable or found in a system or documented you use change control.

[b]To work satisfactorily under a GMP system with out having any problems you will implement Change Control system which performs following functions:

Capture the intent of the change.

Evaluate the effects of the change.

Authorize the change.

Record the facts about the change and the new status.[/b]

In a manufacturing organization, the levels of management and their impact on change are as follows:

[b]Senior management — numerically few; may ask for change, but rarely actually make changes.

Quality departments — numerically larger; audit, monitor and to some extent control change, but again, do not actually make changes.

Engineering departments — frequently smaller than quality departments; prone to making changes during design and construction, but less so postvalidation.

Operation and maintenance departments — numerically large; on site four times as long as quality department, and potentially the greatest engine for change in operational plants.

Process changes: When intended quality parameters are not met as per preapproved specifications that were transfered either from R&D or by Quality unit, changes in process parameters are bound to happen. These are either in scale-up phase or during manufacturing phase. These are to be effectively implemented thru a robust change control system.[/b]

Any deviation is a change and it should be initiated by Change control system.

This is a serious business for Global Multinational facilities who have facilities in multiple places and other continents under different Regulatory systems. To know, Understand, reason and question why such changes happened is necessary for the parent organization.
Regards

3

Mr. Prasad,
Your mean to say planned deviation & unplanned deviation should be govern by change control system. Usually companies have thier SOP if we are making any permanent changes that they are addressing with change control system, if they are going to perform minor changes that they are addressing thrugh planned deviation, if there are any unforeseen deviation or incidental change that addressing though unplanned deviation. Suggest me best.

4

I mean to say any deviation- either planned or unplanned or deviation caused due to errors or repair of a machine – all these must have a change control in a Quality system.
All these changes must follow these steps:

Identification of a Deviation
Effects of a Deviation
Verification of a new design
Risk based consideration of such design so that deviations in future can be minimized
Bringing effective change control implementation for such system.

This is a serious matter and both EU/FDA give much important to Change Control Management system in a Pharma/Biopharma work places where R&D or Manufacturing or Quality control operations are being performed.

The new padigram of Process validation in stage -1 attracts the Change control cause in Validation and Design of Experiments (DoE). This is pretty new to R&D units and slowly the awareness and heat will pick up in this area.

In a quality system when a necessary or intended outcome is not attained due to deviation we invoke the Change control system( may be thru CAPA in manufacturing places). This might be at Quality, Processs or Engg stages.
Regards

5

Yes,

All deviations after suitable evaluation can / should / Must be implemented through Change control.

Tempo…changes are planned departure from std. procedures & should be govern through deviation management, but if you want to make it permanent it must be routed / governed by Change management…

Unforseen departure definetly come under deviation management & suffixed with CAP which on a later stage if required routed through change management.

Happy reading !