API Q1 REQUIREMENTS 중 Special process Revalidation

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1. Process Reval‎idation.

Reval‎idation requirements should always be considered an integral aspect of an original validation approval. Reval‎idation may be time based or event based, for example, if time based it may be determined that a process will be subject to a full or partial reval‎idation every three years, alternatively if event based, a process may be subject to reval‎idation were there are significant changes, e.g. new equipment introductions, new materials applied, change suppliers, revised specifications, etc…

a process needs to be continually monitored to ensure it remains within a validated state. Any change within a product or process, including changes to personnel, equipment, procedures, etc., need to be eval‎uated to determine the potential consequences on validation status.

The identified potential reasons for reval‎idation as:.......... 적용대상기준

– change within a product or process with potential quality impacts,

– changing or negative trends in quality indicators,

– changes in the design of a product which can impact the associated process,

– transfer of a process between facilities,

– change of the application of a process.

the quality system should require a reval‎idation if changes are to be implemented in product packaging, equipment, formulation or processes which have the potential to impact product effectiveness or characteristics. In addition, where there are changes in the supply chain, the potential for subtle, potentially adverse changes in raw material characteristics needs to be considered, which may necessitate a reval‎idation.

2. Reval‎idation and change management.

It is necessary to define procedures for the management of proposed changes to specifications, methods of manufacture, processes, procedure, products, etc…   “Such changes shall be verified or where appropriate validated before implementation, and these activities shall be documented”.

In all change management systems, where proposed change may impact on validated products or processes, the potential impact of the change needs to be assessed in advance of implementation.

On a day to day basis the potential validation impact would ideally be identified 100% of the time, however in reality unforeseen consequences can arise from a change. Additionally, a series of relatively minor changes in themselves may not have a validation status impact, however the combined effect of such changes may be to impact validation status. Therefore, to counter these risks, it is good practice to have an annual validation status review, where the potential of all change on a product or process can be considered.

Where there are effective monitoring and measuring of processes and products and the control of monitoring and measuring devices can identify changes in the validated status of processes and equipment, then data from such monitoring can be utilized in the annual review for justifying the need for reval‎idation or for not reval‎idating.

3. Reval‎idation needs to be risk based.

Any decision on performing an original validation, the extent of an original validation and reval‎idation requirements should be based on a risk assessment. A risk eval‎uation process needs to be in-place which uniformly determines potential risk across processes and products. Where risks exceed a pre-determined threshold, then reval‎idation should be mandated. The organization will predetermine and justify such risk thresholds. The risk assessment, eval‎uation, minimization, control and monitoring process needs to be defined, documented and affectively implemented.

 

4. Reval‎idation summary.

The need for reval‎idation can arise from a number of sources:

– An identification for future and recurring reval‎idation can arise during the initial qualification validations.

– The ongoing performance of products and processes will continually be monitored and analyzed. Deviations in results performance, change in trends, etc., may highlight the need for reval‎idation.

– As changes are proposed to processes, equipment, specifications, etc.., reval‎idation may be required.

– Applicable Standards may demand reval‎idation of critical processes, resulting in a manufacturer needing to define reval‎idation cycle times.

– Organization policy may define reval‎idation expectations as part of an overall organization approach to quality. Equally, a desire to move away from a reliance on verification activities, may demand ongoing reval‎idation.

– Internal audits may highlight weaknesses in process controls and demand process reval‎idations.