How much percentage of deviation is allowed for “Batch size deviation”?
Is there any specific guidelines OR requirements exist for it?
Take a risk based approach for your specific product/process/application. In my experience I have seen criteria where the batch size must be exactly that of the validated size or a deviation is required. I have also seen an allowed +/- 10% variation without deviation. As always with such matters, it is better to proceduralize your approach in advance so decision making is streamlined after the deviation occurs.
It is not a good practice to have deviations in Batch manufcaturing. I agree with Brian regarding the allowed +/- 10% deviations at times in Industry.
We have to understand when such deviation occurs the unit operations like Mixing/Blending/Drying and other parameters get effected. The reason is due to the fact that the R&D and Production start-up team will optimize all these parameters and keep a proper record of Critical control points. At these points the parameters will varie when there is swing either way in quantities. In such casses of deviations it is always risky to release the batch immediately. This batch should go an extended testing for all parameters.
The critical control points must be selected and extended and comprehensive testing must be done at each stage before it gets a release slip to pass to next stage. This batch becomes very crtical for the company.
Most of deviations happen when active ingredient is less than the approved batch size. This happens when an avialbale API or Excipient is found short in stores. The production head takes batch with available material.
The reason for a batch deviation also happens as per requirement of market demad. It might be a 5% or 10% more than actual batch size.
These deviations at times ruin the reputation of company as shop floor production chemists will have a little or no knowledge about how Btach sizes are validated and fixed. It is the responsibility of QA and Compliance department to hold the batch for extended testing and release such batches.
Manufacturing chemists should not have a preconcieved notions about Batch size deviations. If they take it granted it will ruin total compliance procedures.
Technically spaeking no where the Batch should deviate. The reason is Btach sizes are fixed by industries depending up on multiple factors like Capacities, Products, Parameters, Market demands and stability data vaialble from R&D and Pilot studies.
Regards
Dear Mr.lalit,
I 100% agree with Mr.Durgaprasad sir and in addition to that, when the altration ( i.e increasement / decreasement ) are mandatory in the size of a batch first of all an appropriate rationalised deviation has to be raised supported by OOS Progrramme and then if all ingrediants ( ARM/API & Exepients ) are proportionally Increased or decreased the batch deviation can be accepted as for as my exp. is concerned.
As per the specific customer requirement, some cases batch size deviation permitted with pre approval from quality assurance through planned deviations, but the following terms and conditions applicable are…
- The batch size should not varied +/- 10% variation of batch size
- The equipment operating range should be feasible for proposed batch size.
- The proportional quantities of the raw material shall be calculated, verified and
approved prior to change implementation. - Training shall be impart to relevant personnel prior to deviation of the batch size.
The deviation batch quality and productivity shall be assessed and the batch shall be released after satisfactory review from QA.
There is no specific guideline available for batch size deviation, but the proposed deviation should not affect the quality and yields of the batches.
El sistema de gestión de cambio debe ser el que capte esta propuesta de cambio de tamaño lote, sobre todo si es un proceso validado.
El cambio del tamaño del lote debe realizarse sobre el Maestro de Producción actualizado y aprobado posterior a la Validación de Proceso.
El cambio se considera no significativo o de bajo impacto, si dentro del proceso total, el sub-lote de una de las operaciones unitarias discontinuas( ej: amasado, secado, lubricado) cambia a un tamaño, que sea múltiplo entero.
Siempre y cuando, se mantengan los parámetros críticos de proceso dentro del rango normal de operación.
Antes de realizar el cambio, este debe ser aprobado por QA y el personal debe ser capacitado del cambio.
Sorry but I don’t think we can accept spanish on this forum
[quote=DANIELQF]El sistema de gestión de cambio debe ser el que capte esta propuesta de cambio de tamaño lote, sobre todo si es un proceso validado.
El cambio del tamaño del lote debe realizarse sobre el Maestro de Producción actualizado y aprobado posterior a la Validación de Proceso.
El cambio se considera no significativo o de bajo impacto, si dentro del proceso total, el sub-lote de una de las operaciones unitarias discontinuas( ej: amasado, secado, lubricado) cambia a un tamaño, que sea múltiplo entero.
Siempre y cuando, se mantengan los parámetros críticos de proceso dentro del rango normal de operación.
Antes de realizar el cambio, este debe ser aprobado por QA y el personal debe ser capacitado del cambio.[/quote]
According to the measurement units, like weight, volume, cell number, substance content conc’n, etc, you can provide the methods or measures and to make verify if the deviation be within a reliable range or not by the method. Prior to this, it would be better to refer to the statistical concept, especially for set up the number of sample points.