Sterilization quality assurance

Baird R.M. Bloomfield S.F.L. (eds) ( 996) Microbial Quality Assurance of Cosmetics, Toiletries andNon-sterile Pharmaceuticals. London Taylor and Francis. 

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) London HMSO. Spooner D.F. (1996) Hazards associated with the microbiological contamination of cosmetics, toiletries andnon-sterile pharmaceuticals. Iw.Microhial Quality Assurance in Cosmetics, Toiletries andNon-sterile Pharmaceuticals, 2nd edn (eds R.M. Baird S.F. Bloomfield), pp. 9-27. London Taylor Francis. 

Baird, R.M., ed.. Microbial Quality Assurance. In Cosmetics, Toiletries and Non-Sterile Pharmaceuticals, Taylor and Francis, London, 1996. 

The equipment sterilization charts are included in the batch production record. The equipment sterilization charts for stability batch are produced in support of this submission. These sterilization charts shall be reviewed by Quality Assurance for adherence to the sterilization cycles specified in the batch records. 

The quality control of the final product must be carried out before release of the batch (except for the sterility and the endotoxin tests for extremely short-lived radionuclides). Consequently, all procedures must not only be very fast but also very accurate, and in all cases it is very important to have a properly established quality assurance system that might permit parametric release of the produced batches. The quality control assays that must be carried out in the radiopharmaceutical includ the following ... 

Quality assurance (QA) testing and recertification of LAF systems and other engineering controls, which support the aseptic process (process auditing), irrespective of quality control, or procedures to demonstrate conformance with product specifications of identity, purity, sterility, and apyrogenicity (product auditing). 

In industry, the LFCB is used to conduct small batch sterile filling operations, in the general manipulation and isolation of non-hazardous materials, and in quality assurance/quality control (QA/QC) sterility testing. 

ASHP technical assistance bulletin, quality assurance for pharmacy-prepared sterile products. AJHP 1993, 50,... 

Baird, R. M. 8c Bloomfield, S. F. L. (1996) Microbial Quality Assurance of Cosmetics, Toiletries and Non-sterile Pharmaceuticals. Taylor 8c Francis, London. 

Quality control and quality assurance of sterile products... 

There are many definitions of quality (see Sharp, 2000). For the purpose of pharmaceutical products the term quality is usually taken to mean fitness for purpose. Not only must the product have the desired therapeutic properties it must also be safe for administration by the route intended. Some products such as injections must be sterile, while others such as oral drugs need not be sterile, but must be free from pathogens that can be contracted via the oral route (British Pharmacopoeia, 2003, Appendix XVID). A great deal more space in the literature is dedicated to quality of sterile products, but this reflects the additional quality assurance required compared with that for non-sterile products (Sharp, 2000). 

Whereas readers are referred to these specific documents for details available on the Web site http //www.fda.gov/cder/fdama, some of the specifics are briefly mentioned here. The essence of this guidance emphasizes the importance of the overall quality assurance in manufacturing a PET radiopharmaceutical. All equipment and measurements used in the manufacture must be validated. The areas and hoods in which PET radiopharmaceuticals are manufactured must be run in a sterile condition. The personnel responsible for the manufacture must be well trained in the methodology, and an appropriate number of personnel are required in a production laboratory. Each step of the production must be verified and records must be maintained. The sterility and pyrogen testing of the finished product must be performed by appropriate methods. If a PET radiopharmaceutical is to be commercially distributed, appropriate containers and techniques must be adopted for safe shipments. 

To support their high standards, sterile products require the greatest attention to detail in the quality of design stage, the highest quality standards and most effective quality assurance and quality control procedures. The fact that the seal is usually based on rubber means that the effectiveness and integrity of the total closure system has to be evaluated at several phases of the product shelf life, i.e. 

Microbial Quality Assurance in Cosmetics, Toiletries and Non-Sterile Pharmaceuticals... 

The discodermolide isolated from the 6 g campaign proved to be a monohydrate. In agreement with our quality assurance department, we could only use the material from the 60 g campaign and eventually the 500 g campaign without repeating the toxicology if the following conditions were met a) the synthetic route was identical, b) the material produced had the same side product profile c) the material was equally pure or better and d) the same crystal modification was produced (8 or 9 modifications are known) and e) the material was sterile. 

Doolan. P. T.. Dwyer. J.. Dwyer. V, M.. Filch, F. R., Halls. N. A and Tallentire, A. (1985). Towards microbiological quality assurance in radiation sterilization processing A limiting case model. Journal of Applied Bacteriology SSt jM)3-306. 

All instrumentation within aseptic manufacturing facilities should be identified during validation, and the potential of each instrument for causing deleterious effects to sterility should be independently evaluated. All instruments should be calibrated and scheduled for routine recalibration and for routine preventative maintenance. A system should be set up to ensure that any failure to meet these predetermined schedules is flagged to Quality Assurance to evaluate the effect on sterility. 

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