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Saturday, April 9, 2011

Continued Process Verification Process Validation Stage 3

Pharma Process validation,aspects of continued process verification

Continued process verification: can be defined as assuring that during routine pharma production the manufacturing and other processes remains in complete state of control.

Pharmaceutical manufacturing process are required to be validated so as to comply with the requirements of current good manufacturing guidelines on process validation published by US FDA in Jan 2011 they give great emphasis on continued process verification in its guidelines and has stated it as stage 3 in process validation process they say that the objective of the third validation stage in pharma process validation is the continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. FDA stated in its guidelines that a system or systems for detecting unplanned departures or deviations from the process as designed is essential to accomplish this goal. Adherence to the current good manufacturing practices (CGMP) requirements, specifically, the collection and evaluation of information and data about the performance of the process, will allow detection of undesired process variability. Evaluating the performance of the process identifies problems and determines whether action must be taken to correct, anticipate, and prevent problems so that the process remains in control (§ CFR 211.180(e)).
Also see ( process validation in pharma )


An ongoing program to collect and analyze product and process data that relate to product quality must be established (§ CFR 211.180(e)). The data collected should include relevant process trends and quality of incoming materials or components, in-process material, and finished products. The data should be statistically trended and reviewed by trained personnel. The information collected should verify that the quality attributes are being appropriately controlled throughout the process.
FDA has stated in its guidelines that they recommend that a statistician or person with adequate training in statistical process control techniques develop the data collection plan and statistical methods and procedures used in measuring and evaluating process stability and process capability. Procedures should describe how trending and calculations are to be performed and should guard against overreaction to individual events as well as against failure to detect unintended process variability. Production data should be collected to evaluate process stability and capability. The quality unit should review this information. If properly carried out, these efforts can identify variability in the process and/or signal potential process improvements. Also se what is pharma validation

Good process design and development should anticipate significant sources of variability and establish appropriate detection, control, and/or mitigation strategies, as well as appropriate alert and action limits. However, a process is likely to encounter sources of variation that were not previously detected or to which the process was not previously exposed. Many tools and techniques, some statistical and others more qualitative, can be used to detect variation, characterize it, and determine the root cause. US FDA recommends that the drug manufacturer use quantitative, statistical methods whenever appropriate and feasible. Scrutiny of intra-batch as well as inter-batch variation is part of a comprehensive continued process verification program under § cfr 211.180(e). Also se what is validation in pharmaceuticals manufacturing

US FDA recommend continued monitoring and sampling of process parameters and quality attributes at the level established during the process qualification stage until sufficient data are available to generate significant variability estimates. These estimates can provide the basis for establishing levels and frequency of routine sampling and monitoring for the particular product and process. Monitoring can then be adjusted to a statistically appropriate and representative level. Process variability should be periodically assessed and monitoring adjusted accordingly. Also see ( process validation in pharma )

Variation can also be detected by the timely assessment of defect complaints, out-of-specification findings, process deviation reports, process yield variations, batch records, incoming raw material records, and adverse event reports. Production line operators and quality unit staff should be encouraged to provide feedback on process performance. US FDA recommend that the quality unit meet periodically with production staff to evaluate data, discuss possible trends or undesirable process variation, and coordinate any correction or follow-up actions by production.
Data gathered during this stage might suggest ways to improve and/or optimize the process by altering some aspect of the process or product, such as the operating conditions (ranges and set-points), process controls, component, or in-process material characteristics. A description of the planned change, a well-justified rationale for the change, an implementation plan, and quality unit approval before implementation must be documented (§ CFR 211.100). Depending on how the proposed change might affect product quality, additional process design and process qualification activities could be warranted. Also se what is pharma validation
Maintenance of the facility, utilities, and equipment is another important aspect of ensuring that a process remains in control. Once established, qualification status must be maintained through routine monitoring, maintenance, and calibration procedures and schedules (21 CFR part 211, subparts C and D). The equipment and facility qualification data should be assessed periodically to determine whether re-qualification should be performed and the extent of that re-qualification. Maintenance and calibration frequency should be adjusted based on feedback from these activities.FDA guideline

Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical prodct to foreign contries
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Process Validation Series    

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations

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Details on pharma guidelines are here at who guideline blogspot com(whoguideline.blogspot.com)


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