TYPES OF PROCESS VALIDATION

1. Types of process validation

Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation (repeated validation).

Prospective validation is carried out during the development stage by means 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 might lead to critical situations.

CLEANING VALIDATION PROTOCOL FOR PHARMACEUTICALS

1.      Introduction:

The validation of the cleaning procedures is establishing documented evidence that the procedure is effective and capable for removing the contaminants associated with previous products, residues agents as well as the control of potential microbial contaminants.

The cleaning validation is not only ensure the compliance of the regulatory requirements, but a more important benefit for performing cleaning procedure validation is the identification and the correction of the potential problems which could compromise the safety, efficacy or quality of the subsequent batches of drug product.

ANALYTICAL METHOD VALIDATION

  1.       Principle

1.1   This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed and may be acceptable. Manufacturers should choose the validation protocol and