Process Validation

1.0     Purpose     :   To lay down a procedure for process validation.

2.0     Objective   :  To provide documented procedure for process validation.

3.0    Scope       : To define role/responsibility of various functions responsible for process validation.

4.0     Responsibility    :

·        Primary        :         Officer QA/ QC/ Production

·        Secondary    :         Manager QA/ QC/ Production

5.0      Procedure   :

Validation is the act of demonstrating and documenting a procedure which operates effectively. Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.

·        Types of Process Validation:

Ø      Prospective Validation: Validation carried out during the development stage on the basis of a risk analysis of the production process, which is broken down into individual steps; these are then evaluated on the basis of past experience to determine whether they may lead to critical situation.

Ø      Concurrent Validation: Validation carried out during routine production of products intended for sale.

Ø      Retrospective Validation: Involves the evaluation of past experience of production on the condition that composition, procedures and equipment remain unchanged. The source of data for this validation may include batch document, process control chart, maintenance logbook, records of personnel change process capability studies, FP data and stability results.

·        The proposed validation is designed as per the concurrent validation GMP guidelines because of the following reasons:

Ø      All the stages are already commercialized and a large number of batches of each stage are carried out on a large scale.

Ø      All critical quality attributes are established.

Ø      In process checks at each stage for acceptance are established as ‘In-process checks specification’.

Ø      Standard output in terms of quality and quantity is defined and established.

Ø      No failure of process or product at each stage is observed for a large number of batches.

Ø      The process now will be repeated by the standard SOPs for manufacturing, testing, and cleaning at each stage and monitored thoroughly to get output of consistent quality and quantity to create a validation report to comply with concurrent validation provisions.

·        General Concept:

Ø      Three consecutive validations will be performed to prove that the method is validated.

Ø      Whenever a new product is introduced, equipment usage and nature of potential contaminant will be studied to assess whether it poses a challenging study for process validation

·        Description of Process:

Ø      The  manufacturing process comprises of 5 chemical steps, packing and report writing on each step being common for all stages, starting from --. All the stages are taken under purview of the protocol.

R           Stage I:

R           Stage II:

R           Stage III:

R           Stage IV:

R           Stage V l

Ø      Before starting the process equipment should be cleaned and ECR report should be there and all raw materials should be analyzed and attached AR No. report should be attached with process validation report.

Ø      The unit operations with critical process parameter and operating range with in process check is well established as this product is prepared on actual commercial scale. All the three batches that to be taken for process validation is provided in the tabular form.

Ø      Process is well optimized with respect to molar proportion of ingredients, time, temperatures etc.; no parameter needs to be verified in the existing commercial process. Reaction time is the only parameter, which is variable and hence critical. Therefore only time will be monitored as per the frequency given above to establish the consistency of quantity and quality for all V Stages.

Ø      Check that all the stages follow acceptance criteria according to protocol