DRA- process validation

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PROCESS VALIDATION :

PROCESS VALIDATION Submitted by: CH.Raja sekhar , Regd.No.11AB1S0318 M.pharm (pharmaceutics), Vignan college of pharmacy

Contents :

Contents Introduction Various regulatory requirements of validation When should a process be validated Types of process validation Priority for Process Validation Types of documentation. Process validation of some Pharmaceutical Processes

Introduction :

Introduction Why Is Validation Required? It would not be feasible to use the equipment without knowing whether it will produce the product we wanted or not. Efficient u se of resources is necessary for the continued success of the industry. The pharmaceutical industries are concerned about validation because of the following reasons. Assurance of quality Cost reduction Government regulation

Responsible Department :

Responsible Department

Process Validation :

Process Validation Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: - “Process Validation” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes”

General view of process validation :

General view of process validation

Validation of Manufacturing Process:

Validation of Manufacturing Process

QUALIFICATION :

QUALIFICATION Design Qualification (DQ ) Defines the functional and operational specification of the instrument, program, or equipment and details the rationale for choosing the supplier. Installation Qualification (IQ) Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.

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Operational Qualification to provide a high degree of assurance that the equipment functions as intended. Component Operational Qualification of which calibration can be considered a large part. System Operational Qualification to determine if the entire system operates as an integrated whole. Process Performance Qualification: This verifies that the system is repeatable and is consistently producing a quality product. Performance Qualification (PQ) Demonstrates that the process or equipment performs as intended in a consistent manner over time. Test with materials like placebo

When To Validate:

After finalizing formula, process, and specifications Either before or after new drug application (NDA) Approval Prefer to start during process development phase More frequently being done before NDA approval/filing When To Validate

Regulatory Requirements For Validation :

Regulatory Requirements For Validation

Types Of Process Validation :

Types Of Process Validation

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A) Prospective validation Also called as premarket validation Carried out prior to distribution of new product or existing product made under a revised manufacturing processes where such revision may affect product specification or quality characteristic B) Concurrent validation Study is carried out under a protocol during a course of normal production. It gives assurance of present batch being studied and offer limited assurance regarding consistency of quality from batch to batch. This may be practical approach under certain circumstances…. When previously validated process is being transferred to a third party contract manufacturer or to another manufacturing site. Where the product is a different strength of a previously validated product with the same ratio of active / inactive ingredients

C) Retrospective validation :

C) Retrospective validation Conducted for a product already being marketed, and is based on extensive Historical data accumulated over several lots and over time . Some essential elements of retrospective validation:- Batches manufactured for a defined period Batch size/ strength/ manufacturer/ year Master manufacturing/ packaging documents Current specifications for active materials/ finished products List of process deviations, corrective actions and change to mfg. documents Data for stability testing for several batches Trend analysis including those for quality related complaints

D) Revalidation:

All or a portion of validation that is required to be repeated when changes that affect original validation are made. Examples of changes requiring revalidation Changes to product specifications Process parameters Equipment (type, function, location, control system, major repairs) Raw materials Manufacturing materials Packaging material D) Revalidation

Change Control :

Change Control Written procedures should be in place to describe actions to be taken if a change is proposed to a product component, process equipment, process environment, processing site, method of production or testing or any other change that may affect product quality or support system operations. All changes must be formally requested, documented and accepted by the validation team. The likely impact / risk of the change on the product must be assessed and the need for the extent of re-validation should be determined

Validation Master Plan :

Validation Master Plan The format and content should include: Introduction: validation policy, scope, location and schedule Organizational structure: personnel responsibilities Plant/ process /product description: rational for inclusions or exclusions and extent of validation Specific process Considerations that are critical and those requiring extra attention List of products/ processes/ systems to be validated, summarized in a matrix format, validation approach Re-validation activities, actual status and future planning Key acceptance criteria Documentation format Reference to the required SOP’s Time plans of each validation project and sub-project.

Validation Protocol :

Validation Protocol General information & Objective Responsibility Protocol Approval Validation Team Process Flow Chart Manufacturing Process Review of Equipments / Utilities, Raw Materials and Packing Materials, Validation Procedure Sampling Location Documentation Acceptance Criteria Summary & Conclusion

Documentation (GMP):

Documentation ( GMP) To define the specifications for all materials, method of manufacture. To know the information necessary to decide whether or not to release a batch of product for sale. To provide on audit trial that shall permit investigation of the history of any suspected defective batch.

Requirements for documentation:

Requirements for documentation Every applicant or hold for a registration certificate should be in possession of master documentation. Master document should be authorized and the name of the applicant or holder of registration certificate should be visible. Possession of master documentation is a pre-requisite of medicine. The registration dossier should be in compliant with master documentation. There should be written procedure for updating of master documentation and the system should ensure that current approved master documentation is being used.

EQUIPMENT VALIDATION:

EQUIPMENT VALIDATION Any major equipment changes after the initial validation will result in the need for subsequent revalidation. In the end, equipment validation will create specification ranges and tolerances that will be applied to the normal operation of equipment.

EQUIPMENT VALIDATION:

EQUIPMENT VALIDATION As mentioned earlier, each piece of must be validated in order to legally operate within the facility. The goal is to produce consistent results with minimal variation without compromising the integrity of the product and the persons operating the equipment. A plan of validation should be drafted and executed by engineers in order to satisfy guidelines. The validation plan generally consists of IQ and OQ sections.

Some Common Variables In The Manufacture Of Tablet Products :

Some Common Variables In The Manufacture Of Tablet Products • Particle size of drug substance • Bulk density of drug substance/excipients • Powder load in granulator • Amount and concentration of binder • Mixer speed and mixing times • Granulation moisture content • Milling conditions • Lubricant blending times • Tablet hardness • Coating solution spray rate

Approaches to Improve Process Validation #1 :

Approaches to Improve Process Validation #1 Focus on “newness” anything new like components or raw materials, equipment, process or package steps, dosage form • Adequate trials at full-size for new item • Assure raw material/component is from vendor’s routine production Complete review of pre-validation documentation Adequately identify cause and correct problems Data used in establishing operating ranges and specifications Data submitted to regulatory agencies

Approaches to Improve Process Validation #2 :

Approaches to Improve Process Validation #2 Handling out-of specification (OOS) results Identify if caused by equipment, product, normal process variation, or error or combination May require additional experimentation Pursue conservative approach, if unsure of cause Mechanism to bring development/validation issues to team management for resolution Review meetings Team approach Open, honest interaction

References:

I. R. Berry, R. A. Nash , Pharmaceutical Process Validation, Eastern Hemisphere Distribution, 3 rd edition 2003 Elsie J, Augustine O Review article:An Overview of Pharmaceutical Validation and Process Controls in Drug Development Tropical Journal of Pharmaceutical Research, December 2002; 1 (2): 115-122 Guideline on General Principles of Process Validation (www.fda.gov/cder/guidance/pv.htm), May 1987) Quality System Regulation, Title 21 Part 820 of the Code of Federal Regulations (www.accessdata.fda.gov/scripts/cdrh/ cfdocs / cfcfr / CFRSearch.cfm ? CFRPart =820 (Apr 2003) References

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