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Responsibility department and their responsibility for Process Validation

The validation working party is convened to define progress, coordinate and ultimately, approved the entire effort, including all of the documentation generated.

The working party would usually include the following discipline members, preferably those with a good insight into the company’s operation.[16]

Table 2: Responsibility department and their responsibility for Process Validation

Department or Designee


3rd Level of Process


Prepare and review the validation protocol. Ensue regarding the Title, Market, Batch Size, Report no, Batch details, Product details, Reference documents.

2nd Level of Process


Responsible for execution of process validation batch. Ensure that the information regarding reason for validation, product specification & acceptance criteria, measuring device used, batch fabrication details, in-process characteristics, validation data, results & conclusion.

1st Level of Process


Review validation protocol and clarify validation report. Also ensure that batches are executed as per the plan and approved protocol. Prepare periodic revalidation calendar.


Review validation protocol and certify validation report. Review periodic revalidation calendar.

2nd level of Quality

Assurance Manager

Responsible for withdrawing sample as defined in the validation protocol. Review the protocol with respect sampling plans and procedure, and validation sample analysis results. Responsible for analyzing the samples as per defined specification/procedure details in the protocol and responsible for review and approval of validation protocol and certify validation report.

Head (Engineering)

Review the equipment and area in perfect working condition as required shall certify the above in validation protocol and validation report.

Manager Operation

Review and ensure that the information regarding batch details, product details, pack details of input material, equipment used, batch fabrication details, in-process characteristics, yield monitoring, result & conclusion.


Regulatory Person

Review the batch details, product details, pack details of input material with respect to the regulatory requirements and approved dossier in case of commercialized products in the validation protocol and certify the validation report.

Head (Quality Assurance)

Approve the validation protocol for implementation and certify the validation report.

Validation protocol

Detailed protocol for performing validations are essential to ensure that the process is adequately validated. Process validation protocols should include the following elements:

  • Scope of coverage of the validation study.
  • Objectives Validation team membership, their qualifications and responsibilities.
  • Type of validation: prospective, concurrent, retrospective, re-validation.
  • Number and selection of batches to be on the validation study.
  • A list of all equipment to be used; their normal and worst case operating parameters.
  • Outcome of IQ, OQ for critical equipment.
  • Requirements for calibration of all measuring devices.
  • Critical process parameters and their respective tolerances.
  • Process variables and attributes with probable risk and prevention shall be captured.
  • Description of the processing steps: copy of the master documents for the product.
  • Sampling points, stages of sampling, methods of sampling, sampling plans.
  •  Statistical tools to be used in the analysis of data.
  • Training requirements for the processing operators.
  • Validated test methods to be used in process testing and for the finished product.
  • Specifications for raw and packaging materials and test methods.
  • Forms and charts to be used for documenting results.
  • Format for presentation of results, documenting conclusions and for approval of study result[16,17]

Process Validation Decision

The following model may be useful in determining whether or not a process should be Validated

Process Validation Decision Tree

(i) Process Validation Decision Tree for change in process controls of manufacturing process of drug products:

The pharmaceutical Process Validation is the most important and recognized parameters for in-process materials and finished product . The product should be designed robustly enough to withstand variations in the manufacturing process and the manufacturing process should be capable and stable to assure continued safe products that perform adequately. Process validation involves a series of activities taking place over the lifecycle of the product and process.  Validation has been proven assurance for the process efficiency and sturdiness and it is the full fledged quality attributing tool for the pharmaceutical industries and making different type dosage form and solution. Validation is the commonest word in the areas of drug development, manufacturing and specification of finished products. It also renders reduction in the cost linked with process monitoring, sampling and testing. Apart from all the consistency and reliability of a validated process to produce a quality product is the very important for an industry.

The Importance of process validation are-Assurance of Quality-Validation is an extension of the concepts of quality assurance since close control of the process is necessary to assure product quality  end product testing, in the absence of validation, gives little assurance of quality for variety reasons, among which are very limited sample size. The limited number of tests performed on a sample. For example, it is impractical to test for all potential impurities or contaminants. The limited sensitivity of the test.

Process Optimization-The optimization of a process for maximum efficiency, while maintaining quality standards, is a consequence of validation. Literal meaning of word to optimize is “To make as effective, perfect or useful as possible”. The optimization of the facility, equipment, systems, and processes results in a product that meets quality requirements at the lowest cost.

Reduction of quality costs -Finally it can be concluded that process validation is a key element in the quality assurance of pharmaceutical product as the end product testing is not sufficient to assure the quality of finished product


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