Pharmaceuticals process validation program

Spiller, B. A. Process validation program. AstraZeneca (Stuart) Pharmaceuticals Internal Document, July 28, 1978. 

Stress testing is used to help identify degradation pathways under the influence of accelerated heat, light, and RH conditions in the presence or absence of air or oxygen. Such stability testing protocols represent an important aspect of a pharmaceutical ingredient process validation program. 

It should be noted that not all parameters that are critical to the manufacturing process are critical with regard to product quality some parameters may be designated critical for process performance, safety, health, or environmental reasons. Because of the nature and importance of these other critical parameters, it is usual for pharmaceutical manufacturers to consider them under the validation program. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

All necessary activities and responsibilities for the qualification and validation are controlled and specified in this Validation Master Plan. Every step of the described validation program for facilities, equipment, processes, process controls, and cleaning is in accordance with the current European Community Guidelines for GMP and FDA, and the cGMP guideline for finished pharmaceutical manufacturers. All requirements in these directives are fulfilled in this validation process. 

The pharmaceutical manufacturer must establish effective policies and plans for regulatory compliance and validation to enable individuals to clearly understand the company commitment and requirements. Computer validation planning should ensure an appropriate training program, preparation of validation guidelines and procedures, system GMP compliance risk and criticality assessment, a documented validation strategy and rationale, clearly defined quality-related critical parameters and data for the manufacturing process. 

To fulfill these requirements, a complete program for validation has been developed for ABC Pharmaceutical Company to ensure that all processes and equipment affecting the quality, integrity, safety, and efficacy of the pharmaceutical product are qualified and validated. 

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