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WHO issues supplementary guidelines on GMP on sterile process validation

 

The World Health Organization (WHO) has issued guidelines for the revision of the supplementary guidelines on good manufacturing practices: on-sterile process validation. The industry will need to revert with their views by May 24.

Further to the Supplementary Guideline on good manufacturing practices: validation, as published in the WHO Technical Report, No. 937,1 102 additional guidelines to support current approaches in GMP are published herewith to further support the scope of process validation linked to quality risk management and quality by design principles as described by WHO and the International Conference on Harmonization (ICH).

The guideline allows for different approaches in process validation. The principles are applicable to non-sterile finished pharmaceutical dosage forms.

Thorough knowledge of product and process development studies; previous manufacturing experience; and quality risk management (QRM) principles are essential in the all approaches to process validation as the focus is now on the life-cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and maintenance of the process during routine commercial production.

A risk based approach to validation is recommended, linked to in-line or on-line controls and monitoring to ensure that a process is in a state of control during routine manufacture process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture, stated WHO in its draft report.

The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available for inspection. Manufacturers should confirm that a manufacturing process is under control before a product is placed on the market.

Process validation is associated with the collection and evaluation of data, from the process design stage through commercial production, which provides scientific evidence that a process is capable of consistently delivering a quality product. Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the required quality.

A risk assessment approach should be used to determine the scope and extent to which process(es) and starting material variability may affect product quality. The critical parameters should be identified and documented and be based on knowledge of the product or processes concerned, according to the stage of the product life-cycle.

The objectives of process validation is to ensure that the design is evaluated to show that it is reproducible. The commercial manufacturing process is defined and controlled, and that the validation should cover all manufactured strengths used for production of the marketed product. A matrix approach may be acceptable based on appropriate risk assessment, according to WHO.

The scope and extent of continuous process verification will be influenced by a number of factors. These include prior development and manufacturing knowledge from similar products. The extent of process understanding gained from development studies and commercial manufacturing experience. The complexity of the product manufacturing process and the level of process automation and analytical technologies used.

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