1. OBJECTIVE

To lay down specific procedure for product / process validation of new as well as existing formulation to have a documented evidence that each specific process will consistently yield a product meeting all its predetermined design and quality specifications.

  1. RESPONSIBILITY
  • Scientist – For the development of process
  • Manager- Validation — To review the validation batches
  1. PROCEDURE
  • All the products / process of new as well as existing product shall be validated.
  • Validation shall be carried out as per the approved protocol with detailing methods, conditions, procedures, test and acceptance criteria.
  •  The product / process validation shall involve following types of technique depending upon the approach used to carry out validation activity.
  •  Prospective process validation

3.4.1  This approach to validation shall be under taken as a new product or a product manufactured by revised formula/ manufacturing procedure where in the revision is expected to alter the product characteristics. This validation activity shall be undertaken before the commercial distribution of the batch and in associated with the technology transfer from Formulation research and Development to production. The number of batches to be taken up for the validation study shall be three consecutive batches or in line with the regulatory requirement of the country where filing is proposed.

The validation batches (if applicable) shall be subjected to stability studies following  current SOP on stability studies.

  •  Retrospective Process Validation

3.5.1  This approach of validation shall be undertaken as products already in commercial   distribution and have a long history of compliance to established standards.

  • Retrospective validation shall involve in depth analysis of production, testing and control data. A minimum of ten consecutive batches shall required for data generation to certify the process

3.6       Concurrent Process Validation

3.6.1    This approach of validation shall be undertaken during actual process of product manufacture and shall involve monitoring of critical processing steps and final product analysis to generate data to establish that the process is under control.

  • The number of batches to be taken up for validation study shall be three consecutive batches or in line with the regulatory requirement of that particular country.
  • The Validation batches (if applicable) shall be subjected to stability studies by following the current SOP on post production stability studies.

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3.7      Revalidation

3.7.1   Process revalidation shall be undertaken when a change occurs in a previously validated process, the change which could have an impact on product characteristics. Even if there is no change in the previously validated process then also process to be revalidated after every five years.

3.7.2  The revalidation is required in case of

  • Change in Batch Size
  • Change in manufacturing location / site
  • Change in component
  • Change in critical equipment
  • Change in process
  • Change in the vendor of the critical ingredient of the formulae.
  • A series of batch fail to meet product specification
  • Revalidation shall be done in response to the change control procedure my concerned department.
  • Depending upon the nature of the change directly revalidation for a validated product, a supplementary validation protocol may be issued with eliminatory certain portions of sampling procedure and tests where the process is not affected by the change. Information from the earlier validation exercise shall support the areas not revalidated.
  • Validation protocol shall be prepared by elaborating in detail plan of sampling, monitoring of  the process, testing of the samples, evaluation, acceptance criteria for the compliance of the product to designed product attributes.
  • A typical Validation protocol should address the following areas.
  • A. Protocol Approval
  • B. Overview

1. Objective

2. Purpose

3. Reason for validation

4. Responsibility

5. Validation stage

C. Product details

  • Product Name
  • Generic Name
  • Product Design
  • Batch Details
  • Location of manipulating
  • Market
  • Product Packs
  • Stipulated manufacturing and storage condition
  • Product acceptance criteria

D. Reference documents

  • Master formula Record
  • Master formula / Batch packing record
  • Superseded Master formula / BPRR / BPAR.
  • Standard operating procedure
    • Process validation
    • Test monitoring
    • Sampling (Unit dose)
    • Unit dose sampler
    • QA sampling
    • All of the SOP’s of the manufacturing

E. Manufacturing process

  • Process flow chart
  • Raw material acceptance criteria
  • Equipments and materials
  • Manufacturing check sheet.

F. Sampling procedure and acceptance criteria

  • Validation sampling procedure and acceptance criteria.
  • QA Sampling and acceptance criteria

G. Additional information (if require)

  • Particle size distribution
  • Bulk density / Tapped density

H. Documentation

  • Qualification Report
  • Batch Production Record
  • HVAC

3.9   Validation protocol shall have the approvals of responsible persons of the  following functions

  • Process development / QA
  • Production
  • Engineering
  • Drug regulatory affairs
  • Quality assurance

The same personnel shall sign any changes in the protocol.

3.10  Based on the results generated during the study performed as per approved validation protocol, a validation report shall prepared by concerned scientist of process development validation report shall have the certificated of involved functional head.

3.11  A process qualification report shall be compiled what includes approved  validation protocol and report.

3.12  Due to some reason if a revalidation of the products / process carried out the supplementary protocol and report shall be added to the qualification report.

3.13  If for some reason it is not possible to manufacture required number of batches in succession of complete the prospective / concurrent validation exercised the data obtained during production process along with the product testing data of a particular batch may be reviewed and batch may be released.

3.14  The subject batch shall be closely monitored during production, subjected to additional tests and shall meet the requirements of the acceptance criteria set in the validation protocols. Subsequent batches may be taken up for validation when planned.

3.15  The QA manager shall finally approves the validation batches may be taken for the validation when planned.

3.16  Based on the validation results the product development scientist shall finalize the manufacturing procedure, set in process limits and freeze the product / process steps

3.17  Revised master formula (if required) incorporating the findings / recommendations to validation report to be issued by product development the findings / recommendation of validation and report to be issued by product development to subsequent production.

  1. ABBREVIATIONS

4.1       QA       –           Quality Assurance.

4.2       FRD     –           Formulation Research Development.

  1. REFERENCES

Nil.

  1. ANNEXURES

Nil