Raw material specifications

In the laboratory or process research section a laboratory procedure for a fine chemical is worked out. The resulting process description provides the necessary data for the determination of preliminary product specifications, the manufacture of semicommercial quantities in the pilot plant, the assessment of the ecological impact, an estimation of the manufacturing cost in an industrial-scale plant, and the vaHdation of the process and determination of raw material specifications. 

Contamination. Manufacturers of cosmetics must be careful to guard against chemical and microbial contamination. Chemical contamination, which may result from the presence of undesirable impurities in raw materials, is avoidable by adhering to rigid specifications for raw materials. Compendial specifications and pubHcations by the CTFA and other professional societies form the basis of most intracompany raw material specifications. Moreover, all packaging components must meet not only physical and design specifications but also such chemical requirements as extractables and absence of dust and similar contaminants (see Packaging, cosLffiTics and pharmaceuticals). 

It is of paramount importance to make sure that the operating company has a full understanding of all analytical product and raw materials specifications w ithin the plant at the earliest study stage. Such specifications have major impact on capital and operating costs. 

These results must be shared (ASAP) with Tom in the warehouse. Together we conclude that careful venting of the drums and then-prompt use would be safe. The raw material is perfectly acceptable— and has probably received more thorough analysis than any lots received in quite some time Furthermore, an investigation, with the supplier of the ethoxylate, is undertaken to learn whether sodium borohydride has been used in our shipments in the past or if this was a one-time mistake. If it was not a mistake, can it be eliminated In addition, the recommendation was made to change our raw material specification by reducing the amount of allowable moisture and raising the lower pH limit. Finally, a full report on this incident was written for the company files. 

The final step in the Problem Solving process is to report the results to the customer with whom you have been working so hard. However, it is not enough to report just the results. The problem is not solved until appropriate recommendations have been made. In the Bulging Drum Problem, these included proper use/disposition of the raw material, changes to raw material specifications, and conversations with the supplier. The problem is not solved until the paperwork (i.e., Memo, Report, Recommendation, etc.) is completed ... 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

Examples of a few oral suspensions in which a specific and well-defined particle-size specification for the drug substance is important include phenytoin suspension, car-bamazepine suspension, trimethoprim and sulfamethoxazole suspension, and hydrocortisone suspension. It is therefore a good idea to indicate particle size in the raw material specification, even though it is meant for dissolving in the processing, to better validate the manufacturing process while avoiding scale-up problems. 

The name, type, class, style, grade, item code number, or other precise identification traceable to the raw material specification. 

Raw material specifications and their acceptable limits. All raw materials are tested before they are used in a pharmaceutical product. These materials must meet quality standards or meaningful specifications, and their limits must be set so that the use of unsafe, impure, and inefficacious materials will not be allowed in the product. The control labs will run the tests or have a contractor perform them, but QA will ensure that the lab procedures are properly followed and documented. Furthermore, QA will ensure that no raw materials were released improperly. 

List of all applicable reports supporting formulation and design development (e.g., safety reports for excipients, raw material specification justification report for excipients). 

A common error is to limit the types of deviations reported to and evaluated by the APR system to just deviations from finished-product specifications. All deviations should be evaluated, including deviations from manufacturing procedures, in-process specifications, deviations from raw material specifications, and other expected results. Each of these occurrences could indicate changes are necessary to prevent recurrence. For example, the cause of deviations from manufacturing procedures is frequently evaluated as a lack of training. If there are several of these occurrences by different individuals, however, it is also likely that there maybe another root cause, such as unclear or insufficient batch record instructions or inadequately designed or unclear batch record data forms. 

Section 1 - Project and Process. This starts with the project definition (objective, description, location, product and raw material specifications, quantity, quality, output requirements, throughput for equipment sizing purposes). Closely linked with this is a statement of the mode of operation (e.g. day time only or 24 hour operation, continuous or batch processing) and expected control philosophy (centralised computer or local, methods of data collection and storage, programmable controllers or hard-wired ). 

Raw material specifications—lists of vendors and specifications for each material used in the step with particular attention to the impurity content of intermediates that contribute to the structure of the final API. 

In the case of purification there will be target specifications for the final product and these must be clearly defined at the start of the process. The raw material specifications are equally... 

Raw material specifications that are not documented in the development report... 

The comparative chemical cleanliness, residual contaminant level, and control over the properties of carbon blacks produced through the furnace process cannot be overstated. Carbon blacks containing high levels of residue and chemical contamination may adversely affect end-use performance. For plastics used in sensitive applications such as fiber and for some engineering resin formulations, raw material specifications require low levels of chemical and residual contaminants. 

Raw material specifications and testing Weighing of batch ingredients according to DMF-filed recipe ... 

Formulation Formulation Primary production lot - summary of raw material specifications... 

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