What you should know for effective handling deviations in a pharmaceutical company
Definition of Deviation: Any observed and non-observed departure of value or an event or procedure or action from set parameter, written and approved standards or acceptable limits or statements is called as deviation. If someone do not follow or finds a difference in what is done and what is in written instructions while manufacturing, sampling, storage of Raw material, sampling of raw as well as finished product, during testing of raw, bulk, and finished product, or packing material, by virtue of the requirement or by virtue of circumstances, such events are called as deviations.
There are two types of deviations: 1) Planned deviation 2) Unplanned Deviation.
Any deviation done with permissions from quality assurance department and Facility heads, Regulatory agencies are called as planed deviations.
Any accidental departure from set standards set parameters acceptable limits or statements is called as incidence, and it is categorized as unplanned deviation.
For any planned deviations, detailed information of what is written instructions, procedures, or set parameter should be mentioned along with what is the outcome of the planned deviation. Before approving a planned deviation, a comparison and impact evaluation on all systems is required to be done and if the outcome do not affect the final quality of product and do not adversely affect the systems, it can be accepted based on risk assessment and procedure to eliminate root cause through corrective and preventive actions. For any planned deviation before execution a written approval of deviation is must.
For an unplanned deviation, it should be treated as an incidence or an accidental case, and investigation is required to be conducted by considering all systems, we have described in detail how to do investigation under topic handling of market complaints. Risk assessment should be done, investigation should be done and a root cause must be found out for the unplanned deviations. These root causes must be addressed or eliminated through proper designing and implementation of corrective and preventive action. An unplanned deviation should not be approved without investigation and mitigation of root cause of the deviation, through corrective and preventive actions, impact of the deviation on other systems must be done to evaluate the quality of final product is not affected by any unplanned deviation.
Reporting of an incidence or deviation in a pharmaceutical manufacturing company must be done immediately as it happens to head of the department, further he will have to report the same within 12 hours to Quality assurance department in written format. Till then if the deviation is going to affect the equipment, procedure, process, system, further activity should be halted until the approval of deviation, if CAPA is must it should be implemented before proceeding for further activity.
Why it is necessary to log a deviation?
It is important to eliminate the root cause of the deviation so that it do not occur repeatedly otherwise there is risk to the quality of product being manufactured. Without reporting a deviation one can’t do mitigation hence all sorts of deviations must be reported and logged immediately.
Regulatory requirements for deviation:
If a pharmaceutical company do not have a system to identify report and investigate and to mitigation of deviations its considered as lack of adequate quality management system therefore it becomes violation of GMP guidelines, therefore even if the product meets the standard and it is manufactured in a facility that lacs adequate quality management system, such product is termed as substandard product.