Pharmaceuticals process validation report

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

In the present chapter, the pharmaceutical industry validation system has been reviewed. To have an appropriate validation system it is first required to define which equipment, facilities, and processes will be validated, when they will be validated, and by whom this must be performed. This definition is based on a risk assessment priority and is written in a specific document, the so-called MVP. In order to generate an adequate validation report, all the validation activities should be described in the validation protocols, SOPs, and specific procedures. 

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. 

WHO expert committee on specifications for pharmaceutical preparations, 34th report. Good Manufacturing Practices Guidelines on Validation of Manufacturing Processes (Annex 6). Geneva World Health Organization, 1996. 

Part II Part II is the report concerning chemical, pharmaceutical, and biological documentation. The report details the composition, method of development of formulation, manufacturing processes under GMP, analytical test procedures, bioavailability, and bioequivalence. It should be noted that all analytical test procedures need to be validated, and the validation studies must be provided. 

On completion of the DQ process the pharmaceutical manufacturer s qualification summary report must record the completion of the DQ and acceptance of the system at site for the in situ qualifications required by the validation life cycle. 

The validation life cycle is typically split into eight main qualification phases as shown in Table 21.2 and are all execnted under the control of a Validation Plan. It must be clearly demonstrated that the Qnality Assnrance (QA) fnnction of the pharmaceutical manufacturer is endorsing the validation approach for the implemented LIMS as docnmented in the Validation Plan. In its simplest form this will reqnire the QA representative to anthorize the Validation Plan and the subsequent key documents prodnced to support validation (e.g., Qnalification documentation. Reports, etc.). Table 21.2 shows the linkage between project activities and the QuaUflcation process, which will be under the control of the Validation Plan. 

Additionally, the issuance of guidelines for pre- and post-New Drug Application approval inspections do provide, as the title suggests, guidance to the field inspector (and the pharmaceutical industry) on what should be addressed in the product development report (2,3). These considerations include the characterization of the final blend of the granulation and establishment of specifications to be used in the validation study. Establishing finished product specifications and in-process requirements are among the most important and critical steps in prod-... 

The recent literature on microwave-assisted chemistry has reported a multitude of different effects in chemical reactions and processes and attributed them to microwave radiation. Some of these published results cannot be reproduced, however, because the household microwave ovens employed often have serious technical shortcomings. Published experimental procedures are often insufficient and do not enable reproduction of the results obtained. Important factors required for qualification and validation, for example exact records, reproducibility, and transparency of reactions/processes, are commonly not reported, which poses a serious drawback in the industrial development of microwave-assisted reactions and processes for synthesis of fine chemicals, intermediates, and pharmaceuticals. Technical microwave devices for synthetic chemistry have been on the market for a while (cf a.m. explanations) and should enable comparative investigations to be conducted under set conditions. These investigations would enable better assessment of the observed effects. It is, furthermore, possible to obtain a better insight into the often discussed (nonthermal) microwave effects from these experiments (Ref. [138] and Chapter 4 of this book). Technical microwave systems are an important first step toward the use of microwave energy for technical synthesis. The actual scale-up of chemical reactions in the microwave is, however, still to be undertaken. Comparisons between microwave systems with different technical specifications should provide a measure for qualification of the systems employed, which in turn is important for validation of reactions and processes performed in such commercial systems. 

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