Processes and Procedures

The primary thmst of GMP is that it is not enough merely to make chemicals to meet USP or other apphcable specifications. The chemicals must be made under clean and sanitary conditions, procedures and processes must be vahdated and documented, and processing and packaging must be carried out under conditions that preclude mixup and mislabeling. Records must be kept of complaints, and the manufacturer must know enough about the storage properties of the products to specify storage conditions and, if necessary, expiration dates on the label. 

Sec. 820.70 Production and process controls - Address production procedures and process controls, changes to the process, environmental controls, clothing and hygiene of personnel, prevention of contamination, suitability and layout of buildings, equipment qualification, maintenance, periodic inspection, and adjustment, removal of unwanted manufacturing materials from devices and automated (computer controlled) processes... 

Reproducibility of Manufacturing Processes The aim of GMP is to ensure the manufacture of safe, potent, pure, and effective drug in a consistent manner. The development program exists to evaluate procedures and processes that can be implemented in a large-scale manufacturing environment to ensure the drug product conforms to the intended safety, potency, purity, effectiveness, and consistency on a routine basis. 

For registrable devices, the MRA included an 18-month transition period, to allow each party to gain confidence in the other s procedures and processes for pre-market assessment. 

An example of the minimum requirement for potency assay of the drug substance and drug product is tabulated in Table 4. Note that the postponement of intermediate precision is aligned with previous discussion that the use of early phase analytical method resides mainly in one laboratory and is used only by a very limited number of analysts. Each individual company s phased method validation procedures and processes will vary, but the overall philosophy is the same. The extent of and expectations from early phase method validation are lower than the requirements in the later stages of development. The validation exercise becomes larger and more detailed and collects a larger body of data to ensure that the method is robust and appropriate for use at the commercial site. 

Having a set of procedures written down and in place is only the very first small step down the road to a Total Quality organisation. The key to going further along this road, is to recognise that all procedures and processes can be continuously improved. The activity of continuous improvement requires the involvement of all staff, at whatever level in the organisation. In this activity nobody is exempt, least of all the Manager, who must lead by example [B-32]. 

Arindam Bose (Pfizer Central Research) further discussed the ICH documents and presented a rationale for the recommended combination of test procedures and process clearance validations required to demonstrate that marketed biopharmaceuticals are free of adventitious agents. He showed that testing of Pre-Seed Stock (PSS), the Master Cell Bank (MCB), and the Working Cell Bank (WCB) is required to demonstrate that they are free from contamination by mycoplasma, bacteria, molds, and yeasts. In addition, viral clearance validation studies must be performed on scaled down versions of each chromatographic step and the viral inactivation/removal step employed in the product purification scheme. Finally, clearance studies must be conducted with a panel of relevant and model viruses (typically three to four) to establish that the purification scheme will indeed purge any viruses that may be inadvertently introduced during processing. 

A risk assessment should also be conducted that will focus primarily on the procedures and processes that have to be put in place to ensure the maintenance of a high quality of service. Issues of concern include (1) robustness of the POCT device, (2) quality of the results produced, (3) competence of the operator of the device, (4) effectiveness of the process for transmission of the results to the caregiver, (5) competence of the caregiver to interpret the results provided,... 

The primary objective of this chapter is to highlight current industry best practices in effecting successful method transfers for those carrying out ligandbinding assays in biological matrices, usually plasma or serum. In most instances, the data generated support pharmacokinetic and/or pharmacodynamic evaluations as part of the chug development process. However, the procedures and processes are applicable to any GXP environment only the acceptance criteria will vary. 

Newly developing fields of science are organized according to universally recognized classifications using well-defined terms to describe the fundamentals, correlations, equipment, procedures, and processes. This is not the case for those technologies that were known for centuries and have been developed empirically and independently for different applications (see also Chapters 2 and 3). In such cases the same process, procedure, activity or piece of equipment may have different names in different industries or the same term may have different meanings in different fields of application. 

In drug manufacture and supply the terminology may differ. In particular, the term "quality system" is rarely used, and it is "quality assurance" that usually embraces such elements as organizational structure, procedures, and processes. 

FL Bryan. Risks of practices, procedures and processes that lead to outbreaks of foodborne diseases. J Food Prot 51(8) 663-673, 1988. 

For this report the committee did not evaluate the two ACWA program sites at Pueblo Chemical Depot (Colorado) and Blue Grass Army Depot (Kentucky). However, the committee suggests that ACWA government and contractor management personnel review this report in detail for information, issues, and recommendations that have potential applicability to the ACWA program procedures and processes. This is particularly important since the ACWA sites... 

There is a view commonly held that the chemical war, like other aspects of the scientific war of 1914-18, was more characterized by rapidity and size, than by innovation or inventiveness. Without denying speed and scale, this easy formula masks the complexity of the task that confronted industry. To neglect this is to downplay the significance of inventiveness and innovation of many kinds, and the skill-base of the people involved. Scaling up from untested designs took time and involved factors that tested ideas, procedures, and processes. Each has its importance in the history of applied science. If such issues are not viewed as sufficiently fundamental to be included in the history of science, this suggests a professional shortsightedness we must resist. 

Concluding the effect of procedures and processing parameters on the rate and efficiency of osmotic dehydration it can be stated that all of them are equally important. The kind and concentration of the osmoactive substance, the weight ratio of the solution to food, the kind of osmosed material, its size and shape, temperatnre and pressure, and the pretreatment of the material prior to osmosis affect strongly not only the course of the process but also, first of all, influence the quality and organoleptic attributes of the final product. 

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