Validation guidelines

The International Gonference on Flarmonization (IGH) is attempting to standardize regulations and testing for pharmaceutical products. This 

The ICH committee consists of six members the European Commission of the European Union (EU), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health and Welfare, Japan (MHW), the Japan Pharmaceutical Manufacturers Association (JPMA), the US. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). Additional members include observers from the World Health Organization (WHO), European Free Trade Association, and Canada (Health Canada). The International Federation of Pharmaceutical Manufacturers and Associations (IFPM A) has been closely involved with ICH since its inception. This mixture of governmental agencies and professional representatives is performing an exceptional task developing one set of guidelines for three major markets. 

However, in the case of NIR spectroscopy, and when it comes to nonlinear relahonships in complex, single-, or multicomponent mixtures, the physics are a little less understood (or understood by fewer workers). Certainly, the mathematical techniques used to unravel the mysteries of complex nonlinear instrument signals are even less widely understood. 

What this means is that an educational process should be undertaken for industrial analysts and the agency addressing the complexities of NIR spectroscopy. Analysts must educate themselves about chemometrics before practicing NIR spectroscopy. They must also develop guidelines and create appropriate laws to regulate a field that is just beginning to be understood and appreciated. 

Sample Selection, Spectra Collection, Modeling, Cross-Validation, Statistical Evaluation 

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Method validation guidelines for use in trace analysis have been proposed by various authors, but there is little consistency in the recommended approaches. The general validation guidelines proposed by standards organizations such as ISO (International Organization for Standardization), DIN (Deutsches Institut fUr Normung German Institute for Standardization) and others are often not well defined and consequently... 

Method qualification is based on ICH method validation guidelines. Method type (purity or identity) will dictate the level of qualification testing necessary. Several strategies for method qualification and validation exist and are based on needs, resources available, and the project timeframe. One approach is to perform minimal development and qualification, which may be necessary for projects with shorter timelines, but it may place more burden and risk on future validation activities for robustness testing, and can result in failure. As discussed in Chapter 4, an alternate approach would invest more time and resources into method development, followed by extensive qualification and robusmess testing to determine if further development is... 

SUBJECT Hot Air Sterilization Tunnel Certification and Validation Guideline... 

To describe the validation guideline for the ampule and vial hlling machine to be free from contamination during the hlling cycle... 

To describe validation guideline for the computerized equipment to meet the installation qualification... 

To describe the validation guideline for performance qualification of computerized equipment to ensure that it meets the performance requirement... 

Process and equipment validation certification guideline Hot air sterilization tunnel certification/validation guideline Steam sterilization certification/validation guideline Validation and certification of hot air sterilization tunnel Validation and certification of SIP preparation/mobile vessel Validation/revalidation of sterilization cycles in sterilizer by Kaye validator... 

Waters Corporation (2004), Validation Guidelines Terminology and Definitions, available http //www.waters.com/WatersDivision. 

The FDA process validation guidelines [1] refer to a quality assurance system in place that requires revalidation whenever there are changes in packaging (assumed to be the primary container-closure system), formulation, equipment or processes (meaning not clear) which could impact on product effectiveness or product characteristics and whenever there are changes in product characteristics. 

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. 

The early involvment of industry was useful in that it paved the way for the official documents to be issued by the regulators. The first of them was the well-known process validation guideline of the U.S. FDA [3] in 1987. 

Health Canada. Validation Guidelines for Pharmaceutical Dosage Forms. Ottawa Therapeutics Products Programme (2000) www.hc-sc.gc.ca/hpb-dgps/therapeut. 

Validation guidelines must comply with all formal procedural controls established by the company/organization. They are internal documents providing detailed procedures, activities and sample products necessary to successfully execute a computer systems or related project. 

The very critical view, at least theoretically, taken by courts of witness and party testimony is based on the understanding of human nature gained in the course of centuries by many jurists. It should be accepted as a valid guideline by historians as well, even if the methods used to determine truth in scientific pursuits are necessarily different than those employed in court. For example, while a Court must reach an absolute decision regarding what is true and what is false, and must do so within a limited period of time, science cannot, indeed may not reach a conclusive and final verdict if it wants to remain true to its maxim of openness in every respect. Whereas in a court case the close relation of the proceedings to a human fate causes emotion to exert a strong and distorting influence on the process by which the verdict is reached, this influence usually is, or should be, minor in scientific pursuits. 

The Japanese Ministry of Health and Welfare (MHW) [later Ministry of Health, Labor and Welfare (MHLW)] issued its computer validation guideline in 1993.It specifically avoided the validation and qualification terminology, although it covered rudimentary validation requirements ... 

Adding to this problem is the lack of unambiguous, scientifically valid guidelines from the International Conference on Harmonization (ICH) guidance (1). This leads to having to choose between what the user thinks the regulators want and the scientific approach. 

Cleaning Validation Guidelines., Health Canada Therapeutic Products Programme, 1 May, 2000. http //www.hc-sc. gc.ca/hpb-gps/therapeut/zfiles/english/guides/ validate/ validation guide e.pdf(accessed September 2000). 

The FDA LAL test-validation guideline describes how to use all LAL methods and identifies three basic requirements ... 

There is much confusion regarding the definition of process validation and what constitutes process validation documentation. The term validation is used here generically to cover the entire spectrum of current GMP concerns, essential most of which are facility, equipment, component, method, and process qualification. Based upon the FDA process validation guidelines, the specific term should be reserved for the final stage(s) of the product and process development sequence. The essential or key steps or stages of a successfully completed development program are shown in Table 1. 

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