Revalidation in pharmaceutical manufacturing its regulatory and general requirements.
Validation in pharmaceutical is not only mandatory by law or regulation, but also it a is one of the method by which pharmaceutical quality assurance ensure that the drug manufactured in the firm will always meet the required quality standards. Validation is a process of collecting or gathering and documenting the evidence in terms of operating parameters, therefore revalidation is essential for ensuring that the any changes done in process environment and process machinery methods scale ups ect, will not change alter or affect product quality and its characteristics.
We can classify of Revalidation as follows
1) Revalidation after any change in the product formula, process ,method which affect the quality of product.
2)Scheduled periodic Revalidation.
Revalidation after changes.
It is mandatory to carry out revalidation if there are changes made in manufacturing process, procedures, methods, formula, equipments, raw material, packaging material, manufacturing aria support systems like water and steam, and in process controls or any other changes in an established quality product which may alter or affect the quality of the product.
Qualified validation team should review any requested changes in above mode, and decide about the revalidation and revalidation procedure. Some of the performance tests and procedures, for process and equipments adapted while carrying out first validation may be adapted in the revalidation as well.
Which are the major changes which require revalidation?
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.
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.
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.
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.
See also media fill run
Why there should be periodic revalidation:
A drug product may under go 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 and preplanned scheduled revalidations enables a firm to be repaired and be capable of conducting revalidation efficiently and effectively. Revalidations conducted and plans are inspected by regulatory agencies world wide during FDA inspections.
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.
Important points before revalidation must be verified:
Implementation of revised standard operating procedures.
Analytical method, if there are any changes in the analytical methods they must be validated before the process revalidation up on which all results depend.
Scheduled cleaning and sanitization plan completed.
Preparation of master formula if there is any change in the product formula
Change in batch size, rational for change, and its effect on the quality of the product should be considered before implementation and then considered for revalidation.
Calibration of instruments, which will be used during the process after a change, is implemented.
Preventive maintenance is completed. It should be completed on schedules.
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