process validation of drying&compression

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process validation

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PROCESS VALIDATION OF DRYING &COMPRESSION:

PROCESS VALIDATION OF DRYING &COMPRESSION Under the guidance of M. SANTHOSH KUMAR Department of Pharmaceutics presented by E.PRIYANKA M.Pharmceutics 1 st yr

WHY TO VALIDATE A PROCESS:

WHY TO VALIDATE A PROCESS Process validation of a finished product is required by the CGMP regulations. Process validation should be performed because, it is in accord with good business judgement. Validation helps to ensure product uniformity, reproducibility, &quality.

VALIDATION:

VALIDATION Is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it’s pre-determined specifications & quality characteristics.

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PHASES IN VALIDATION Phase1: pre-validation qualification phase Phase2: process validation phase phase3: validation maintenance phase TYPES OF PROCESS VALIDATION Prospective validation. Retrospective validation. Concurrent validation. Revalidation.

VALIDATION TEAM:

VALIDATION TEAM Organization Responsibility Engineering Install, qualify, and certify plant, facilities, equipment, and support system. Development Design and optimize manufacturing process within design limits, specifications, and/or requirements—in other words, the establishment of process capability information. Manufacturing Operate and maintain plant, facilities, equipment, support systems, and the specific manufacturing process within its design limits, specifications, and/or requirements. Quality assurance Establish approvable validation protocols and conduct process validation by monitoring, sampling, testing, challenging, and/ or auditing the specific manufacturing process for compliance with design limits, specifications, and/or requirements.

VALIDATION OF DRYING:

VALIDATION OF DRYING Validation of raw materials Validation of equipment Design qualification Installation qualification Operational qualification Performance qualification Validation of process

VALIDATION OF RAW MATERIAL:

VALIDATION OF RAW MATERIAL Each raw material validated by testing at least 3 batches from primary & alternate supplier ; which representing the acceptable ranges, both high and low . Depending on the susceptibility of the raw materials to aging , physical, chemical , and/or microbiological stability should be assessed If under acceptable range , especially for materials sensitive to small changes; The final step of raw material validation should involve an on-site inspection of the vendor’s to review the manufacturing operations, controlling & conforming to regulatory requirements.

EQUIPMENT VALIDATION:

EQUIPMENT VALIDATION Operating principle of the dryer Will the wet material be static Working load range& capacity of equipment Heating range& air flow capabilities Heat distribution

VALIDATION OF DRYING:

VALIDATION OF DRYING Inlet/outlet temperature Air flow Moisture uniformity Equipment capability/capacity

TROUBLES BECAUSE OF IMPROPER DRYING:

TROUBLES BECAUSE OF IMPROPER DRYING Over drying(low moisture content): Poor hardness Friability Less drying(high moisture content): Picking/sticking Poor chemical properties

PARAMETERS TO BE CONSIDERED FOR COMPRESSION:

PARAMETERS TO BE CONSIDERED FOR COMPRESSION Particle size uniformity Particle shape Flow property Compressibility index Moisture content

VALIDATION OF COMPRESSION:

VALIDATION OF COMPRESSION Raw material validation Equipment validation: Determination of parameters of machine Evaluation of parameters Specifications

VALIDATION OF COMPRESSION:

VALIDATION OF COMPRESSION Tooling Compression speed Compression/ejection force In process tests should be examined during compression: Appearance Hardness Tablet weight Friability Disintegration Weight uniformity

` PROBLEMS FACED :

` PROBLEMS FACED Rat holing bridging Sticking Picking Lamination Capping Double impression& Weight variation

REFERENCES:

REFERENCES Nash R A., Wachter A.H., Pharmaceutical process validation, 3 rd edition, Marcel Dekker publication.. Lachman L., Liebberman H.A., Kania J.L., The theorty and practice of industrial pharmacy, 3 rd edition, Varghese publishing house.. N. K. Jain & S. N. Sharma, A Text Book of Professional Pharmacy, Vallabh Prakashan ..

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