Facilitated by: Dr. T. M. Pramodkumar Professor JSSCP, Mysore.

Prepared by: Hardik Pandya 1st M.Pharm Regulatory affairs JSSCP, Mysore
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 Re-validation

provides the evidence that changes in a process and /or the process environment that are introduced do not adversely affect process characteristics and product quality. Documentation requirements will be the same as for the initial validation of the process.

It would not be feasible to use the equipments without knowing whether it will produce the product we want or not. The pharmaceutical industry uses expensive materials, sophisticated facilities & equipments and highly qualified personnel. The efficient use of these resources is necessary for the continued success of the industry. The cost of product failures, rejects, reworks, and recalls, complaints are the significant parts of the total production cost. Detailed study and control of the manufacturing processre-validation is necessary if failure to be reduced and productivity improved.

The pharmaceutical industries are concerned about Re-validation because of the following reasons. Assurance of quality Cost reduction Government regulation

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Revalidation after any change in the product formula, process ,method which affect the quality of product. Scheduled periodic Revalidation.

Following changes requires re-validation: Raw material, starting material: Drug product and its process should be revalidated if there are changes in the starting material, even if there are change in the physical properties of the starting material like crystal properties, viscosity, bulk density, specific gravity, particle size distribution of the active as well as excipients as these physical properties might adversely affect the process and then product quality.

Packaging material: If there are changes done in packaging material revalidation must be done if the packaging material comes directly in contact with dosage form as well as if the physical properties of the packaging material being changed may affect the stability and quality of the drug.

Manufacturing process: Re validation must be done whenever there are changes in manufacturing process like change in the time required for the process like mixing, homogenization, recirculation cooling time, and temperatures applied for various processes.
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Equipments: Re validation must be done whenever there are changes in equipment like instruments used for various measurements in manufacturing and in process quality assurance, even their repair and changes in the spare parts and components must be considered for revalidation. Support systems and maintenance: Revalidation must be done whenever there are changes and repairing is done in the support systems ( water system ventilation and air handling systems) and production area these changes may be critical on product quality, for example if the manufacturing aria is for sterile products which may affect product quality, clean room environment and sterility of the product in case of sterile product manufactured by aseptic process.

A drug product may undergo changes over the time for improvement in its formulation for efficacy and quality. The equipment and the support systems may undergo wear and tear as well, therefore revalidation becomes important requirement hence adapting a intentionally. Pre-planned scheduled revalidations, enables a firm to be capable of conducting revalidation efficiently and effectively. The frequency and period of revalidation can be decided by studying data collected on regular basis from all in process quality control parameters and quality control reports of finished product.

Additionally, the following points should be checked at the time of a scheduled revalidation: Have any changes in master formula and methods, batch size, etc., occurred? If so, has their impact on the product been assessed? Have calibrations been made in accordance with the established programme and time schedule? Has preventive maintenance been performed in accordance with the programme and time schedule? Have the standard operating procedures (SOPs) been properly updated? Have the SOPs been implemented? Have the cleaning and hygiene programmes been carried out? Have any changes been made in the analytical control methods? 10

 http://whoguideline.blogspot.com/2011/06/

revalidation-aspects-revalidate-in.html http://pharmaceuticalvalidation.blogspot.co m/2008/01/types-of-process-validation.html

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Do you Have any queries friends

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